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Testosterone

Testosterone Enanthate · Testosterone Cypionate · Testosterone Propionate · Testosterone Undecanoate

Sex Hormones & TRTApproved
MW
288.4g/mol
Formula
C19H28O2

Testosterone is a steroid hormone classified as an androgen, primarily produced in the testes in males and in smaller amounts in the ovaries and adrenal glands in females. Researchers primarily study testosterone for its role in regulating muscle mass, strength, and various physiological processes. Key findings from studies indicate that testosterone administration can lead to significant increases in fat-free mass and muscle size, with dose-dependent relationships observed in muscle strength and protein synthesis. Additionally, clinical evidence suggests that testosterone levels are associated with various androgen-dependent processes, which may respond differently to changes in testosterone concentration. Current research continues to explore the implications of testosterone in both health and disease, particularly in the context of testosterone deficiency and its therapeutic applications.

Overview

Übersicht

Testosterone is a steroid hormone that is both endogenously produced in the testes of males and in smaller amounts in the ovaries of females, as well as synthetically manufactured for therapeutic use. It belongs to the androgen class of hormones and is a primary male sex hormone responsible for the development of male reproductive tissues and secondary sexual characteristics. Researchers have extensively studied testosterone for its role in muscle mass and strength enhancement, as well as its effects on body composition and metabolic processes. Testosterone plays a crucial role in regulating various physiological processes, including muscle protein synthesis, fat distribution, bone density, and the maintenance of libido and mood. Researchers have observed that testosterone's effects on muscle mass and strength are dose-dependent, with higher doses leading to greater increases in fat-free mass and muscle size. The mechanism of action of testosterone involves binding to androgen receptors, which are nuclear receptors that regulate gene expression. Upon binding, the hormone-receptor complex translocates to the nucleus and influences the transcription of specific genes, leading to increased protein synthesis and muscle growth. Testosterone is metabolized primarily in the liver, and its pharmacokinetic properties vary depending on the form administered. For instance, testosterone enanthate and cypionate are long-acting esters used in intramuscular injections, while testosterone undecanoate is available for oral administration. Clinically, testosterone is used in hormone replacement therapy for men with hypogonadism, and its use is regulated by various health authorities. It is important to note that while testosterone can be beneficial in treating deficiencies, its misuse can lead to adverse health effects, and it is classified as a controlled substance in many countries.

Chemical profile

Chemische Struktur

Chemical structure of Testosterone
FormelC19H28O2
Molekulargewicht288.4g/mol
CAS-Nummer58-22-0
PubChem CID6013
Mechanism

Wirkmechanismus

Testosterone acts primarily on androgen receptors, which are part of the nuclear receptor family. Upon binding, the testosterone-receptor complex translocates to the cell nucleus, where it influences the transcription of genes involved in male sexual development and anabolic processes, leading to increased muscle protein synthesis and growth.

Mechanism

Signalweg

Testosterone primarily exerts its effects through binding to androgen receptors (AR) in target tissues, initiating androgen receptor signaling pathways that regulate gene expression. This activation leads to increased muscle protein synthesis, enhanced muscle mass, and strength, as well as modulation of fat metabolism and erythropoiesis. While the precise molecular mechanisms are still being elucidated, the signaling pathways involved include the AR-mediated transcriptional activation of anabolic genes and the modulation of insulin-like growth factor I (IGF-I) signaling.

Half-Life & Pharmacokinetics

ENEndogenous

Circulating half-life ~70 minutes

IMIntramuscular

~8 days (enanthate ester), ~14 days (cypionate ester)

TDTransdermal

Steady-state after 24-48h

POOral

Poor bioavailability due to first-pass metabolism

Testosterone enanthate and cypionate are long-acting esters, while testosterone undecanoate is designed for oral use with improved bioavailability.

Storage

Temperature

Store at room temperature (15-30C)

Light

Protect from light

Form

Oil solution stable for 2+ years

Notes

Ensure vials are sealed properly to prevent contamination.

Solubility

Löslichkeit

Testosterone is highly soluble in oil, which is relevant for its formulation in injectable preparations.

Legal Status

🇩🇪DE

Testosterone is a prescription-only medicine (verschreibungspflichtig) and is regulated under the Betäubungsmittelgesetz (BtMG) as a controlled substance.

🇺🇸US

Testosterone is FDA-approved for use in testosterone replacement therapy and is classified as a Schedule III controlled substance by the DEA, requiring a prescription.

🇦🇺AU

In Australia, testosterone is classified as a Schedule 4 (S4) prescription-only medicine under the Therapeutic Goods Administration (TGA).

🇬🇧UK

In the UK, testosterone is classified as a prescription-only medicine (POM) and is regulated by the MHRA.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Open Questions

Offene Forschungsfragen

Current evidence is limited regarding the specific dose-response relationships of testosterone across various androgen-dependent processes, as existing studies primarily focus on muscle mass and strength without addressing cognitive and sexual functions comprehensively. Further research is needed to clarify the long-term effects of supraphysiologic testosterone doses on health outcomes, particularly in diverse populations, including older men and those with comorbid conditions. Additionally, larger randomized controlled trials are necessary to explore the safety and efficacy of different testosterone formulations and delivery methods in treating testosterone deficiency, as well as their impact on cardiovascular health and metabolic parameters.

176 Research Publications

6,501

Total Citations

97

Human/RCT

4.0

Avg. Influence

2025

Latest

Sort
Filter
#01

The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men.

Bhasin S, et al. · The New England journal of medicine · 1996

HumanInfluence52.0
1080
Researchers observed that supraphysiologic doses of testosterone significantly increased fat-free mass, muscle size, and strength in normal men, particularly when combined with strength training.

Key findings

  1. 01Testosterone increased muscle size in both arms and legs compared to placebo.
  2. 02Participants combining testosterone with exercise gained more fat-free mass and strength than those who did not exercise.
  3. 03Mood and behavior remained unchanged across all groups.
#02

Testosterone dose-response relationships in healthy young men.

Bhasin S, et al. · American journal of physiology. Endocrinology and metabolism · 2001

HumanInfluence25.0
917
The study demonstrated that testosterone administration in healthy young men resulted in dose-dependent increases in fat-free mass, muscle size, strength, and power, with varying dose-response relationships for different androgen-dependent processes.

Key findings

  1. 01Higher testosterone doses resulted in greater increases in fat-free mass and muscle strength.
  2. 02Changes in muscle size and strength were closely linked to testosterone levels.
  3. 03Sexual function and cognitive abilities did not significantly change with varying testosterone doses.
#03

Effect of testosterone on muscle mass and muscle protein synthesis.

Griggs R C, et al. · Journal of applied physiology (Bethesda, Md. : 1985) · 1989

HumanInfluence11.0
492
The study demonstrated that pharmacological doses of testosterone enanthate increased muscle mass and muscle protein synthesis in normal male subjects.

Key findings

  1. 01Muscle mass increased by 20% on average.
  2. 02Muscle protein synthesis increased by 27%.
  3. 03Total body potassium also increased significantly.
#04

Outcomes of long-term testosterone replacement in older hypogonadal males: a retrospective analysis.

Case ReportInfluence11.0
324
Researchers observed that long-term testosterone replacement therapy in older hypogonadal males improved libido and increased hematocrit, while being well tolerated by the majority of subjects.
#05

Treatment of male hypogonadism with testosterone enanthate.

HumanInfluence6.0
280
The study demonstrated that testosterone enanthate effectively suppressed serum LH and FSH levels in men with primary hypogonadism, with varying efficacy across different dosage regimens.
#06

Testosterone suppresses hepcidin in men: a potential mechanism for testosterone-induced erythrocytosis.

HumanInfluence10.0
250
Researchers observed that testosterone administration significantly suppressed serum hepcidin levels in men, correlating with increased hematocrit and hemoglobin levels, particularly in older men.
#07

Effect of testosterone cypionate on postexercise ST segment depression.

HumanInfluence7.0
156
Researchers observed that testosterone cypionate treatment significantly reduced postexercise ST segment depression in men, suggesting potential cardiovascular benefits.
#08

Effects of testosterone replacement on sexual behavior in hypogonadal men.

HumanInfluence3.0
154
The study demonstrated that testosterone replacement improved sexual behavior in hypogonadal men, with a critical testosterone threshold identified between 2.0 and 4.5 ng/ml.
#09

Intramuscular injection of testosterone undecanoate for the treatment of male hypogonadism: phase I studies.

AnimalInfluence4.0
147
Researchers observed that testosterone undecanoate in castor oil has a longer half-life compared to testosterone undecanoate in tea seed oil, making it a promising option for hypogonadal men.
#10

Testosterone treatment comes of age: new options for hypogonadal men.

ReviewInfluence7.0
139
Researchers observed that new testosterone formulations, including transdermal gels and injectable undecanoate, provide more stable serum testosterone levels and improved patient compliance compared to older methods.

Clinical Trials (154)

Preclinical
Phase I
Phase II
Phase III
Approved

154

Total Trials

14,515

Total Enrolled

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate or Salivary Gland Cancer

NCT00588185RECRUITING
Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

300

Started

2003

Primary outcome

To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI.

Prostate Cancer

Hair Cortisol and Testosterone Levels in Patients With and Without Acute Myocardial Infarction(MI)

NCT01144065COMPLETED
Sponsor

Meir Medical Center

Enrollment

180

Started

2010

Primary outcome

Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups

Acute Myocardial Infarction

Effect of Testosterone Pretreatment in POR

NCT04602143COMPLETED
Sponsor

Hanoi Medical University

Enrollment

165

Started

2018

Primary outcome

Number of oocytes retrieved

Infertility

Testosterone Antidepressant Augmentation in Women

NCT01783574COMPLETED
Sponsor

Massachusetts General Hospital

Enrollment

101

Started

2013

Primary outcome

Depressive Symptom Severity

Depression

Puberty, Testosterone, and Brain Development

NCT06670053RECRUITING
Sponsor

University of Colorado, Denver

Enrollment

100

Started

2024

Primary outcome

Change in headache burden

Gender IdentityGender Dysphoria in Adolescents and AdultsHeadacheTransgender

Testosterone Undecanoate and Quality of Life of Men and Spouses

Sponsor

Meir Medical Center

Enrollment

80

Started

2013

Primary outcome

patient and spouse satisfaction an quality of life

Hypogonadism

Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome

NCT01585831COMPLETED
Sponsor

University of Colorado, Denver

Enrollment

48

Started

2012

Primary outcome

Change From Baseline on the Delis-Kaplan Executive Function System

Klinefelter SyndromeXXY Syndrome

The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

NCT04134130COMPLETED
Sponsor

Lund University

Enrollment

33

Started

2019

Primary outcome

PSA-concentration

Prostate Cancer Recurrent

Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients

Sponsor

London North West Healthcare NHS Trust

Enrollment

30

Started

2022

Primary outcome

Number of days required for a patient to be recruited on the study and how many patients are recruited

Colorectal CancerSarcopeniaHypogonadism, MalePerioperative CareTestosterone Replacement Therapy

Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients

NCT00847314COMPLETED
Sponsor

Bayer

Enrollment

30

Started

2007

Primary outcome

Waist Circumference

Hypogonadism

Testosterone-induced Muscle Memory and Underlying Mechanisms

NCT06188767RECRUITING
Sponsor

Morten Hostrup, PhD

Enrollment

30

Started

2025

Primary outcome

Fiber cross-sectional area

Skeletal Muscle Physiology

The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS

NCT00202241COMPLETED
Sponsor

Queen's University

Enrollment

30

Started

1999

Primary outcome

differences in serum lipid levels

HIVAIDSLipodystrophyHyperlipidemia

Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Enrollment

27

Started

2022

Primary outcome

Progression in the development of secondary sexual characteristics

Delayed PubertyMale Hypogonadism

Androgen Effects in HIV-infected Women

NCT00095212COMPLETED
Sponsor

Massachusetts General Hospital

Enrollment

25

Started

2004

Primary outcome

Lean Body Mass

HIV Infection

Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

NCT00645658COMPLETED
Sponsor

Palo Alto Veterans Institute for Research

Enrollment

17

Started

2007

Primary outcome

Thigh Cross Sectional Area

Kidney FailureKidney Diseases

A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer

NCT01084759COMPLETED
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

16

Started

2010

Primary outcome

Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.

Prostate Cancer

Testosterone Therapy for Pubertal Delay in Duchenne Muscular Dystrophy

NCT02571205COMPLETED
Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Enrollment

15

Started

2015

Primary outcome

Total score in the Treatment Satisfaction Questionnaire for Medication (TSQM)

Duchenne Muscular Dystrophy

Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.

Sponsor

Paracelsus Medical University

Enrollment

12

Started

2014

Primary outcome

Salivary testosterone concentration

CircadianExerciseTestosterone

Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism

NCT00613288COMPLETED
Sponsor

University of Aarhus

Enrollment

12

Started

2007

Primary outcome

Testosterone influence on Insulin Sensitivity, Lipolysis and protein metabolism

Hypogonadism

Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors

NCT04551144TERMINATED
Sponsor

St. Louis University

Enrollment

4

Started

2020

Primary outcome

Androgen receptor

Gender IncongruenceTransgenderism

Purification of Testis-Stimulating Factor in Precocious Puberty

NCT00004344COMPLETED
Sponsor

National Center for Research Resources (NCRR)

Enrollment

4

Started

1997

Precocious Puberty

Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma

NCT00631137TERMINATED
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

1

Started

2008

Primary outcome

Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months

Brain and Central Nervous System TumorsMusculoskeletal Complications

Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance

NCT06733350Phase 4RECRUITING
Sponsor

Roswell Park Cancer Institute

Enrollment

600

Started

2025

Primary outcome

Gleason grade progression

Localized Prostate CarcinomaStage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8

Testosterone Replacement in Older Men and Atherosclerosis Progression

NCT00287586Phase 4COMPLETED
Sponsor

Brigham and Women's Hospital

Enrollment

308

Started

2004

Primary outcome

Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)

HypogonadismAtherosclerosis

The Role of 5-alpha Reductase in Mediating Testosterone Actions

NCT00493987Phase 4COMPLETED
Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Enrollment

184

Started

2002

Primary outcome

Change from baseline in fat-free mass, measured by DEXA scanning

Healthy

Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men

NCT07328542Phase 4NOT_YET_RECRUITING
Sponsor

Azurity Pharmaceuticals

Enrollment

144

Started

2026

Primary outcome

Number of participants with changes in 24-hour average systolic ambulatory blood pressure

Hypogonadism, Male

Testosterone Effects on Bone and Frailty

NCT00182871Phase 4COMPLETED
Sponsor

National Institute on Aging (NIA)

Enrollment

140

Started

2001

Primary outcome

Bone density and strength

AgingFrailtyOsteoporosis

Testosterone Replacement in Men With Diabetes and Obesity

NCT01127659Phase 4COMPLETED
Sponsor

University at Buffalo

Enrollment

137

Started

2010

Primary outcome

Insulin Sensitivity

Hypogonadism

Effects of Medications in Patients With Hypogonadism

NCT01601327Phase 4COMPLETED
Sponsor

Gulhane School of Medicine

Enrollment

119

Started

2008

Primary outcome

Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.

Idiopathic Hypogonadotropic Hypogonadism

Effects of Sex Steroids on the Serotonin System

NCT02715232Phase 4UNKNOWN
Sponsor

Medical University of Vienna

Enrollment

92

Started

2017

Primary outcome

blood-to-brain clearance/trapping (K*) of [11C]AMT

Gender Dysphoria

Testosterone Replacement in Metabolic Syndrome and Inflammation

NCT01123278Phase 4COMPLETED
Sponsor

University of Roma La Sapienza

Enrollment

82

Started

2004

Primary outcome

Fat-Free Mass (kg)

HypogonadismMetabolic SyndromeObesityErectile Dysfunction

Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

NCT07092527Phase 4RECRUITING
Sponsor

University of California, San Diego

Enrollment

80

Started

2025

Primary outcome

Evidence of Luteal Activity (ELA)

TransgenderismReproductive Issues

TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY

NCT03325647Phase 4COMPLETED
Sponsor

University of Colorado, Denver

Enrollment

72

Started

2017

Primary outcome

Change in Body Fat Percentage

Klinefelter Syndrome

Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)

NCT03792321Phase 4COMPLETED
Sponsor

University Medical Centre Ljubljana

Enrollment

55

Started

2014

Primary outcome

Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l

Hypogonadism, MaleDiabetes Mellitus, Type 2Obesity

Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery

NCT02734238Phase 4COMPLETED
Sponsor

Pennington Biomedical Research Center

Enrollment

53

Started

2016

Primary outcome

Body Composition at the End of Each Study Phase

Caloric RestrictionExercise

The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism

NCT02111473Phase 4COMPLETED
Sponsor

Gulhane School of Medicine

Enrollment

49

Started

2009

Primary outcome

the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23.

Hypogonadism

Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

NCT00350701Phase 4COMPLETED
Sponsor

University at Buffalo

Enrollment

49

Started

2006

Primary outcome

Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo

Diabetes Mellitus Type 2

Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy

NCT01201863Phase 4COMPLETED
Sponsor

Craig Hospital

Enrollment

46

Started

2010

Primary outcome

Restricted Functional Independence Measure (FIM)

Endocrine DysfunctionTraumaBrain Injury

The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction

NCT00421460Phase 4COMPLETED
Sponsor

Chulalongkorn University

Enrollment

30

Started

2007

Primary outcome

Response of treatment for 4 injections at 1 year; score on an IIEF-5

HypogonadismErectile Dysfunction

Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

NCT00355537Phase 4COMPLETED
Sponsor

Barnsley Hospital

Enrollment

19

Started

2006

Primary outcome

The effect of testosterone replacement on arterial stiffness measured by ultrasound derived index B of the femoral artery in men with a combination of DM, PVD and hypogonadism.

Diabetes MellitusPeripheral Vascular Disease

Effect of Testosterone Replacement on Insulin Resistance

NCT00487734Phase 4COMPLETED
Sponsor

McGuire Research Institute

Enrollment

19

Started

2007

Primary outcome

Change in insulin sensitivity as measured by HOMA-IR

Metabolic SyndromeHypogonadism

Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes

NCT02513940Phase 4COMPLETED
Sponsor

Indiana University

Enrollment

14

Started

2016

Primary outcome

Baseline (Pre-ibutilide) Individualized Rate-corrected QT Interval (QTF)

Long QT Syndrome

Intranasal Delivery of Testosterone and Its Effect on Doping Markers

NCT02611154Phase 4COMPLETED
Sponsor

University of Utah

Enrollment

5

Started

2015

Primary outcome

Steroid Levels in Urine Steroid Profile

Abuse of Anabolic Steroids

Androgen Effects on the Reproductive Neuroendocrine Axis

NCT06450405Phase 4TERMINATED
Sponsor

University of California, San Diego

Enrollment

2

Started

2025

Primary outcome

Evidence of Luteal Activity (ELA)

TransgenderismReproductive Issues

The Testosterone Trials in Older Men

NCT00799617Phase 3COMPLETED
Sponsor

University of Pennsylvania

Enrollment

790

Started

2009

Primary outcome

Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12

Andropause

Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido

NCT00331214Phase 3COMPLETED
Sponsor

Warner Chilcott

Enrollment

533

Started

2002

Primary outcome

To assess the efficacy of testosterone transdermal system (TS) as measured by the change from baseline in the frequency of total satisfying sexual activity captured by the Sexual Activity Log (SAL).

Hypoactive Sexual Desire Disorder

Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)

NCT00185198Phase 3COMPLETED
Sponsor

Bayer

Enrollment

363

Started

2004

Primary outcome

Lean body mass at 6 months

Androgens (Deficiency)Male

Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

NCT01403116Phase 3COMPLETED
Sponsor

Clarus Therapeutics, Inc.

Enrollment

325

Started

2011

Primary outcome

Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL

Male Hypogonadism

Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism

NCT01446042Phase 3COMPLETED
Sponsor

Acerus Pharmaceuticals Corporation

Enrollment

306

Started

2011

Primary outcome

Serum Testosterone Cavg

Male Hypogonadism

Testosterone TRANSdermal Gel for Poor Ovarian Responders Trial

NCT02418572Phase 3TERMINATED
Sponsor

Fundacion Dexeus

Enrollment

290

Started

2015

Primary outcome

Clinical pregnancy

InfertilityPoor Ovarian Response

The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men

NCT00696748Phase 3UNKNOWN
Sponsor

Russian Academy of Medical Sciences

Enrollment

250

Started

2005

Primary outcome

waist-to-hip ratio

Metabolic SyndromeHypogonadism

Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

NCT01573442Phase 3COMPLETED
Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

227

Started

2013

Primary outcome

Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3

ArthralgiaBreast CancerHot FlashesMusculoskeletal ComplicationsSexual Dysfunction

A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

NCT01665599Phase 3COMPLETED
Sponsor

Ferring Pharmaceuticals

Enrollment

180

Started

2012

Primary outcome

The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL

Adult Male Hypogonadism

Testosterone Therapy in Men With Low Testosterone Levels and Metabolic Syndrome or Early Stages of Type 2 Diabetes

NCT00479609Phase 3UNKNOWN
Sponsor

Karolinska Institutet

Enrollment

176

Started

2007

Primary outcome

Insulin sensitivity,

Metabolic Syndrome

A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

NCT02149264Phase 3COMPLETED
Sponsor

Ferring Pharmaceuticals

Enrollment

160

Started

2014

Primary outcome

The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL

Adult Male Hypogonadism

Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors

NCT00075855Phase 3COMPLETED
Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

150

Started

2004

Primary outcome

Overall mood

Cancer SurvivorSexual DysfunctionSexuality and Reproductive IssuesUnspecified Adult Solid Tumor, Protocol Specific

A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

NCT00522431Phase 3COMPLETED
Sponsor

Endo USA Inc., a Keenova Therapeutics Company

Enrollment

149

Started

2007

Primary outcome

Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90

Hypogonadism

Safety and Efficacy Trial of Testosterone Undecanoate

NCT01765179Phase 3COMPLETED
Sponsor

Clarus Therapeutics, Inc.

Enrollment

144

Started

2013

Primary outcome

Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL

Male Hypogonadism

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

NCT06343870Phase 3RECRUITING
Sponsor

University of Sao Paulo General Hospital

Enrollment

140

Started

2025

Primary outcome

Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms

MenopauseTestosterone DeficiencyEstrogen Deficiency

A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

NCT01993225Phase 3COMPLETED
Sponsor

Repros Therapeutics Inc.

Enrollment

120

Started

2014

Primary outcome

Comparison of the proportion of subjects who meet the composite endpoint of normal 24-hour average testosterone and sperm concentration.

Secondary Hypogonadism

Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

NCT00220298Phase 3COMPLETED
Sponsor

Bayer

Enrollment

96

Started

2003

Primary outcome

Efficacy and Safety of long term treatment with TU under real-life conditions

Hypogonadism

Optimizing Protein Intake in Older Americans With Mobility Limitations

NCT01275365Phase 3COMPLETED
Sponsor

Brigham and Women's Hospital

Enrollment

92

Started

2011

Primary outcome

Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)

Mobility Limitation

Lifestyle Intervention and Testosterone Replacement in Obese Seniors

NCT02367105Phase 3COMPLETED
Sponsor

VA Office of Research and Development

Enrollment

83

Started

2015

Primary outcome

Change in the Physical Performance Test

Obesity and Hypogonadism

A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations

NCT00857454Phase 3COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

71

Started

2008

Primary outcome

Change From Baseline MTE08 to MTE09 Endpoint in Draize Score

Hypogonadism

The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity

NCT06489457Phase 3COMPLETED
Sponsor

University Medical Centre Ljubljana

Enrollment

25

Started

2020

Primary outcome

Change in semen volume from baseline and between the treatment arms

Type 2 Diabetes MellitusObesityFunctional Hypogonadism

Effect of PROGRESSive Training and Teststerone in Older Frail Men

NCT02873559Phase 2/3COMPLETED
Sponsor

University Hospital, Gentofte, Copenhagen

Enrollment

192

Started

2016

Primary outcome

Stand-up-and Sit-test

Muscle Weakness

PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate

NCT01327495Phase 2/3COMPLETED
Sponsor

University of Washington

Enrollment

62

Started

2011

Primary outcome

Prostate Tissue DHT Concentrations After Treatment

Healthy

Androgen for Leydig Cell Proliferation

NCT01206270Phase 2/3COMPLETED
Sponsor

University of Roma La Sapienza

Enrollment

56

Started

2009

Primary outcome

Nodule Size per Number

Klinefelter SyndromeHypergonadotropic HypogonadismHypergonadotropic AzospermiaHypergonadotropic Cryptozoospermia

Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?

NCT05964920Phase 2/3COMPLETED
Sponsor

Norwegian School of Sport Sciences

Enrollment

45

Started

2024

Primary outcome

Fat-free mass

Healthy AgingAge-Related SarcopeniaTestosterone Deficiency

Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial

NCT07260825Phase 2/3NOT_YET_RECRUITING
Sponsor

TriHealth Inc.

Enrollment

44

Started

2025

Primary outcome

Typical pain with vaginal penetration within last 2 weeks

VulvodyniaDyspareuniaLichen Sclerosus of Vulva

Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency

NCT00161304Phase 2/3COMPLETED
Sponsor

Leonard S. Marks, M.D.

Enrollment

44

Started

2003

Men With Low Testosterone Levels

Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study

NCT04456530Phase 2/3UNKNOWN
Sponsor

The Stone Research Foundation for Sports Medicine and Arthritis

Enrollment

15

Started

2020

Primary outcome

Change in MRI Cross Sectional Area of the Quadriceps

Muscle AtrophySurgeryKnee Injuries and DisordersComplication of Surgical ProcedureTrauma

Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

NCT00160342Phase 2COMPLETED
Sponsor

Solvay Pharmaceuticals

Enrollment

1,251

Started

2005

Primary outcome

Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4

Hot Flushes, Menopause, Postmenopause

Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)

NCT00434824Phase 2COMPLETED
Sponsor

Merck Sharp & Dohme LLC

Enrollment

322

Started

2001

Primary outcome

Change from baseline on the total score of the AMS rating scale

HypogonadismAndrogens

The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial

NCT01469988Phase 2TERMINATED
Sponsor

University of Alberta

Enrollment

318

Started

2012

Primary outcome

In patients with chronic heart failure, does 26 weeks of treatment with transdermal testosterone improve peak VO2?

Heart Failure

Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance

NCT02286921Phase 2COMPLETED
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

222

Started

2015

Primary outcome

Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression

Castration Resistant Metastatic Prostate Cancer

Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems

NCT01743235Phase 2COMPLETED
Sponsor

Emotional Brain NY Inc.

Enrollment

207

Started

2012

Primary outcome

Satisfactory Sexual Episodes

Hypoactive Sexual Desire Disorder

Lybrido for Female Sexual Dysfunction

NCT01432665Phase 2COMPLETED
Sponsor

Emotional Brain NY Inc.

Enrollment

196

Started

2011

Primary outcome

The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting.

Hypoactive Sexual Desire Disorder

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

NCT04798469Phase 2RECRUITING
Sponsor

Brigham and Women's Hospital

Enrollment

150

Started

2022

Primary outcome

Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire

Opioid UsePainHypogonadism, Male

Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression

NCT04363164Phase 2RECRUITING
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

150

Started

2020

Primary outcome

Clinical or Radiographic Progression free survival

Castration Resistant Metastatic Prostate Cancer

Sexual Effects of Transdermal or Vaginal Testosterone

NCT06794346Phase 2UNKNOWN
Sponsor

University of Sao Paulo General Hospital

Enrollment

132

Started

2020

Primary outcome

Changes in sexual disorders measured by FSFI (Female Sexual Function index) after 12 and 24 weeks of treatment

Female Sexual DysfunctionPostmenopausal SymptomsTestosterone DeficiencyTestosterone Adverse Reaction

HORMA: Hormonal Regulators of Muscle and Metabolism in Aging

NCT00183040Phase 2COMPLETED
Sponsor

National Institute on Aging (NIA)

Enrollment

108

Started

2002

Primary outcome

measures of fractional synthetic rates of mixed and contractile (actin and myosin heavy chain [MHC]) skeletal muscle proteins and degradation of skeletal muscle (ubiquitin, and proteasome sub-units)

SarcopeniaMuscle WeaknessFrailty

Testosterone and Weight Loss

NCT01616732Phase 2COMPLETED
Sponsor

Austin Health

Enrollment

100

Started

2013

Primary outcome

weight

Obesity in Men

Product Transference Study of Testagen™ TDS®-Testosterone

NCT02733133Phase 2NOT_YET_RECRUITING
Sponsor

Transdermal Delivery Solutions Corp

Enrollment

96

Started

2027

Primary outcome

Transference of Topical Testosterone from Dosed Males to Female Partners As Measured by net change from Baseline of Serum Testosterone in nG/dL expressed as Maximum Serum Concentration or Cmax.

Hypogonadotropism

Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception

NCT00351819Phase 2COMPLETED
Sponsor

Boston University

Enrollment

84

Started

2006

Primary outcome

Brief Pain Inventory (BPI) at Week 14

PainHypogonadism

Multimodality Intervention for Function and Metabolism in SCI

NCT03576001Phase 2COMPLETED
Sponsor

Brigham and Women's Hospital

Enrollment

84

Started

2019

Primary outcome

Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone

Spinal Cord Injuries

Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder

NCT02101203Phase 2COMPLETED
Sponsor

Emotional Brain NY Inc.

Enrollment

80

Started

2013

Primary outcome

The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ).

Hypoactive Sexual Desire Disorder

A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss

NCT00001079Phase 2COMPLETED
Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

80

HIV InfectionsHIV Wasting Syndrome

A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels

NCT01419236Phase 2COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

76

Started

2011

Primary outcome

Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks

Ejaculatory DysfunctionHypogonadism

Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

NCT01724658Phase 2COMPLETED
Sponsor

Chulalongkorn University

Enrollment

70

Started

2012

Primary outcome

female sexual function index score

Female Sexual Dysfunction

Testosterone and Physical Function in HIV+ Men

NCT00260143Phase 2COMPLETED
Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

61

Started

2003

Primary outcome

Stair climb

HIV Associate Weight Loss

The Effect of Testosterone Supplementation on Rehabilitation Outcomes

NCT00037999Phase 2COMPLETED
Sponsor

US Department of Veterans Affairs

Enrollment

60

Started

2001

AgingFrail ElderlyRehabilitation

Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

NCT06084338Phase 2RECRUITING
Sponsor

VA Office of Research and Development

Enrollment

60

Started

2023

Primary outcome

6-month radiographic progression-free survival (rPFS)

Prostate Cancer

Safety of Testosterone Undecanoate i.m. in Hypogonadal Men

NCT00452322Phase 2COMPLETED
Sponsor

University Hospital Muenster

Enrollment

60

Started

1997

Primary outcome

Prostate (size, PSA-level)

Hypogonadism

Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women

NCT00004400Phase 2COMPLETED
Sponsor

Charles Drew University of Medicine and Science

Enrollment

56

Started

1997

HIV InfectionsCachexia

High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers

NCT05011383Phase 2RECRUITING
Sponsor

VA Office of Research and Development

Enrollment

51

Started

2021

Primary outcome

PSA response

Metastatic Prostate Cancer

Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

NCT06059118Phase 2RECRUITING
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

50

Started

2023

Primary outcome

PSA response rate at Cycle 1 Day 64

Prostate Cancer

Study of Testosterone and Athlete Response

NCT03210558Phase 2COMPLETED
Sponsor

Karolinska University Hospital

Enrollment

48

Started

2017

Primary outcome

Aerobic performance

Athletic PerformanceTestosteroneWomen's Health: Female Athlete/Female Athlete Triad

A Dose Ranging Study to Examine TDS-Testosterone 5%

NCT01894308Phase 2NOT_YET_RECRUITING
Sponsor

Transdermal Delivery Solutions Corp

Enrollment

48

Started

2027

Primary outcome

Dose Range Measure of serum levels of testosterone in response to varying doses

Hypogonadotropism

Testosterone and Alendronate in Hypogonadal Men

NCT01460654Phase 2TERMINATED
Sponsor

Massachusetts General Hospital

Enrollment

44

Started

2011

Primary outcome

Percent Change in Spine Bone Density From Baseline to 12 Months

HypogonadismOsteopeniaOsteoporosis

Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.

NCT00104572Phase 2COMPLETED
Sponsor

National Institute on Aging (NIA)

Enrollment

44

Started

2004

Primary outcome

Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density

HypogonadismDiabetesSarcopeniaOsteoporosisDepression

Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

NCT00004771Phase 2COMPLETED
Sponsor

National Center for Research Resources (NCRR)

Enrollment

40

Started

1992

Spinal Muscular AtrophyAmyotrophic Lateral SclerosisSpinobulbar Muscular Atrophy

Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems

NCT01323140Phase 2COMPLETED
Sponsor

Watson Pharmaceuticals

Enrollment

40

Started

2011

Primary outcome

Percent of Subjects With Testosterone Levels in the Normal Range.

Hypogonadism

Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)

NCT04895306Phase 2COMPLETED
Sponsor

Brigham and Women's Hospital

Enrollment

36

Started

2022

Primary outcome

Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire

PainOpioid UseAndrogen DeficiencyBack Pain

Bipolar Androgen-based Therapy for Prostate Cancer (BAT)

NCT01750398Phase 2COMPLETED
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

33

Started

2013

Primary outcome

Patients With PSA <4 ng/mL at the End of the Study

Recurrent Prostate Cancer

CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men

NCT00729859Phase 2COMPLETED
Sponsor

University of Washington

Enrollment

31

Started

2008

Primary outcome

Endothelial Progenitor Cells

Healthy

An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD

NCT06082817Phase 2NOT_YET_RECRUITING
Sponsor

San Diego Sexual Medicine

Enrollment

30

Started

2025

Primary outcome

Testosterone

Hypoactive Sexual Desire Disorder

Bipolar Androgen Therapy + Carboplatin in mCRPC

NCT03522064Phase 2RECRUITING
Sponsor

St Vincent's Hospital, Sydney

Enrollment

30

Started

2018

Primary outcome

PSA Response Rate

Castration-resistant Prostate CancerHomologous Recombination Deficiency

Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients

NCT03678233Phase 2UNKNOWN
Sponsor

University Hospital, Clermont-Ferrand

Enrollment

30

Started

2019

Primary outcome

Pourcentage of patients with normal median value of serum total testosterone

Hypermetabolism in ICULoss of Muscle MassFunctional Disability After ICUICU Acquired HypogonadismTreatment With Testosterone Gel in ICU

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

NCT00695110Phase 2COMPLETED
Sponsor

Clarus Therapeutics, Inc.

Enrollment

29

Started

2008

Primary outcome

Serum Testosterone Average Concentration (Cavg) (ng/dL)

Hypogonadism

Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)

NCT00239590Phase 2COMPLETED
Sponsor

Imperial College London

Enrollment

28

Started

2001

Primary outcome

Myocardial Perfusion

Coronary Heart Disease

Efficacy of an Intranasal Testosterone Product

NCT01252745Phase 2COMPLETED
Sponsor

Acerus Pharmaceuticals Corporation

Enrollment

22

Started

2010

Primary outcome

Cmax of Serum Testosterone

Hypogonadism

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

NCT04460872Phase 2RECRUITING
Sponsor

North Florida Foundation for Research and Education

Enrollment

21

Started

2021

Primary outcome

change in thigh muscle cross-sectional area

Spinal Cord InjurySpinal Cord InjuriesTrauma, Nervous SystemWounds and InjuryCentral Nervous System DiseasesSpinal Cord DiseasesGonadal DisordersEndocrine System DiseasesHypogonadismGenital Diseases, MaleSpinal Cord TraumaInjuries, Spinal CordWalking, DifficultyGait Disorders, NeurologicLocomotion Disorder, NeurologicWounds and InjuriesNervous System DiseasesTestosterone DeficiencyAndrogen DeficiencyHormone Deficiency

Efficacy, Pharmacokinetics and Safety of Testosterone

NCT01370369Phase 2COMPLETED
Sponsor

Ferring Pharmaceuticals

Enrollment

20

Started

2011

Primary outcome

Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.

Testicular Hypogonadism

Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

NCT00924612Phase 2COMPLETED
Sponsor

Clarus Therapeutics, Inc.

Enrollment

16

Started

2009

Primary outcome

Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet

Male Hypogonadism

Pharmacokinetic Study to Determine Time to Steady-state

NCT00911586Phase 2COMPLETED
Sponsor

Clarus Therapeutics, Inc.

Enrollment

15

Started

2009

Primary outcome

Serum T Concentration at Steady State

Male HypogonadismPrimary HypogonadismSecondary Hypogonadism

Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

NCT02697188Phase 2COMPLETED
Sponsor

Clarus Therapeutics, Inc.

Enrollment

12

Started

2007

Primary outcome

Mean Serum Testosterone Cavg

Hypogonadism

Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease

NCT00080756Phase 2UNKNOWN
Sponsor

City of Hope Medical Center

Enrollment

11

Started

2004

Primary outcome

Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300

brca1 Mutation Carrierbrca2 Mutation CarrierBreast Cancer

Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality

NCT04492553Phase 2COMPLETED
Sponsor

Lars Møller Pedersen

Enrollment

7

Started

2021

Primary outcome

Effect of testosterone on QLQ C-30 score

Hypogonadism

Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

NCT01516554Phase 2TERMINATED
Sponsor

Health Sciences Centre, Winnipeg, Manitoba

Enrollment

3

Started

2012

Primary outcome

Change in fatigue (measured with Modified Fatigue Impact Scale [M-FIS])

Multiple SclerosisFatigue

AIDS Wasting in Women: Anabolic Effects of Testosterone

NCT00006158Phase 2COMPLETED
Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Started

1998

AIDS Wasting Syndrome

Effect of Testosterone Treatment on Embryo Quality

NCT01662466Phase 1/2UNKNOWN
Sponsor

Center for Human Reproduction

Enrollment

180

Started

2012

Primary outcome

Clinical and Ongoing Pregnancy

Primary Ovarian InsufficiencyFemale Infertility Due to Diminished Ovarian Reserve

TRT as an Adjunctive ERAS Therapy in ESRD Patients Undergoing Kidney Transplantation

NCT07287800Phase 1/2ACTIVE_NOT_RECRUITING
Sponsor

University of California, Los Angeles

Enrollment

50

Started

2025

Primary outcome

Adverse Events

Hypogonadism, MaleEnd Stage Renal Disease (ESRD)Kidney Transplant

Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum

NCT00156650Phase 1/2COMPLETED
Sponsor

University of Washington

Enrollment

23

Started

2004

Primary outcome

Intratesticular hormone levels

Contraception

Oral Androgens in Man-4: (Short Title: Oral T-4)

NCT00399165Phase 1/2COMPLETED
Sponsor

University of Washington

Enrollment

20

Started

2006

Primary outcome

Dutasteride can suppress the secretion of LH and FSH after four weeks of administration.

Contraception

Testosterone Replacement for Male Opioid Agonist Maintained Patients

NCT01873989Phase 1/2COMPLETED
Sponsor

Yale University

Enrollment

15

Started

2012

Primary outcome

Number of Participants Demonstrating Abstinence

Chronic PainOpioid AddictionSymptomatic Hypogonadism

Subcutaneous Testosterone Project

NCT02229617Phase 1/2COMPLETED
Sponsor

University of British Columbia

Enrollment

14

Started

2015

Primary outcome

Serum Testosterone (Total)

Gender Dysphoria

Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17

NCT06312761Phase 1/2UNKNOWN
Sponsor

University of Washington

Enrollment

10

Started

2024

Primary outcome

average serum testosterone after dosing on day 2

Hypogonadism, Male

Phlebotomy Study of Testosterone Undecanoate

NCT02670343Phase 1/2COMPLETED
Sponsor

Clarus Therapeutics, Inc.

Enrollment

8

Started

2016

Primary outcome

% of Mean Difference in T Concentration Compared to Plain Collection Tube

Hypogonadism

Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults

NCT02203656Phase 1COMPLETED
Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

113

Started

2013

Primary outcome

Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score

Aging

CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy

NCT01378299Phase 1COMPLETED
Sponsor

VA Office of Research and Development

Enrollment

105

Started

2011

Primary outcome

Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene

Hypogonadism

Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

NCT02990533Phase 1COMPLETED
Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

80

Started

2016

Primary outcome

Physical Performance

Aging

Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease

NCT01578473Phase 1COMPLETED
Sponsor

Men's Health Boston

Enrollment

75

Started

2013

Primary outcome

penile curvature

Peyronie's Disease

Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men

NCT02432261Phase 1COMPLETED
Sponsor

Kimberly Myer

Enrollment

44

Started

2015

Primary outcome

Gonadotropin Suppression

Healthy

Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men

NCT00431197Phase 1COMPLETED
Sponsor

Mayo Clinic

Enrollment

40

Started

2004

Primary outcome

LH and Testosterone levels will be evaluated after 4 study visits

Hypogonadism

A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants

NCT01725451Phase 1COMPLETED
Sponsor

Eli Lilly and Company

Enrollment

30

Started

2012

Primary outcome

Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone

Healthy Participants

Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

NCT00878995Phase 1COMPLETED
Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

28

Started

2009

Primary outcome

Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.

CachexiaSquamous Cell Carcinoma

Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism

NCT02966652Phase 1COMPLETED
Sponsor

Neurocrine UK Limited

Enrollment

25

Started

2016

Primary outcome

Testosterone serum concentrations - Peak Plasma Concentration (Cmax)

Male Hypogonadism

Testosterone Replacement in Renal Failure

NCT02712944Phase 1TERMINATED
Sponsor

Texas Tech University Health Sciences Center

Enrollment

21

Started

2016

Primary outcome

Change in dosage of Erythropoietin stimulating agents (ESA)

Hypogonadism

A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers

NCT01962454Phase 1COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

20

Started

2014

Primary outcome

Change from Baseline in muscle derived protein synthesis rate

Cachexia

A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®

NCT01096329Phase 1TERMINATED
Sponsor

VIVUS LLC

Enrollment

16

Started

2010

Primary outcome

To measure the amount of testosterone in the blood after dosing

Hypoactive Sexual Desire Disorder

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

NCT06305598Phase 1RECRUITING
Sponsor

Roswell Park Cancer Institute

Enrollment

14

Started

2024

Primary outcome

Androgen receptor (AR) activity

Castration-Resistant Prostate CarcinomaMetastatic Prostate CarcinomaStage IVB Prostate Cancer AJCC v8

ORAL T-8 Oral Testosterone for Male Hormonal Contraception

NCT01167829Phase 1COMPLETED
Sponsor

University of Washington

Enrollment

14

Started

2010

Primary outcome

Maximum Testosterone Concentration

Healthy

Testosterone MD-Lotion Residual Washing Study

NCT00996151Phase 1COMPLETED
Sponsor

Acrux DDS Pty Ltd

Enrollment

10

Started

2009

Primary outcome

The amount of Testerone MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.

Hypergonadism

Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

NCT03345797Phase 1TERMINATED
Sponsor

Acerus Biopharma Inc.

Enrollment

8

Started

2018

Primary outcome

Maximum plasma concentration (Cmax)

Hypogonadism

Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption

NCT04166786Phase 1COMPLETED
Sponsor

Parc de Salut Mar

Enrollment

4

Started

2019

Primary outcome

Change in steroid profile in urine

Healthy Volunteers

Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer

NCT02995330Phase 1TERMINATED
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

3

Started

2017

Primary outcome

Prostate-specific Antigen (PSA) Response

Prostate Cancer

[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer

NCT02297386Phase 1COMPLETED
Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

3

Started

2014

Primary outcome

increase in standardize uptake values (SUV) between the second and third FDHT scans

Prostate CancerLocalized Prostate Cancer

Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy

NCT00006044Phase 1COMPLETED
Sponsor

Memorial Sloan Kettering Cancer Center

Started

2000

Prostate Cancer

Testosterone Therapy in Castration Resistant Prostate Cancer

NCT03734653Early Phase 1COMPLETED
Sponsor

University of Colorado, Denver

Enrollment

30

Started

2019

Primary outcome

Feasibility of the Administration of Transdermal Testosterone Alternating with Enzalutamide

Prostate CancerCastration-Resistant Prostate Cancer

Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome

NCT04327934Early Phase 1TERMINATED
Sponsor

Yale University

Enrollment

28

Started

2017

Primary outcome

Baroreflex Response to LBNP

Polycystic Ovary SyndromeHypertension

The Influence of Testosterone on Experimental Pain Perception

NCT05781685Early Phase 1COMPLETED
Sponsor

University of New Mexico

Enrollment

20

Started

2017

Primary outcome

Pain Tolerance

Acute Pain

Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy

NCT01697345Early Phase 1COMPLETED
Sponsor

Creighton University

Enrollment

12

Started

2013

Primary outcome

Total Female Sexual Function Index (FSFI) Score

Breast CancerVaginal DrynessDyspareuniaSexual Health Quality of Life

Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents

NCT02679274Early Phase 1TERMINATED
Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

3

Started

2016

Primary outcome

Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)

Aging

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