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Hormone · Profile

Dutasteride

Avodart · Dual 5-ARI

Hormone ManagementApproved
MW
528.5g/mol
Formula
C27H30F6N2O2

Dutasteride is a synthetic 4-azasteroid classified as a 5-alpha-reductase inhibitor, primarily produced in the prostate gland and hair follicles. Researchers primarily study dutasteride for its potential efficacy in managing androgenetic alopecia, a common form of hair loss. Key findings from clinical studies suggest that dutasteride may be more effective than finasteride in reducing dihydrotestosterone (DHT) levels, with comparable tolerability, although both medications are associated with sexual and neurological side effects. Current research is exploring various administration methods, including topical formulations, to minimize systemic side effects while maximizing efficacy. Clinical evidence indicates that dutasteride is gaining recognition as a viable option for androgenetic alopecia, warranting further investigation into its long-term safety and effectiveness.

Overview

Übersicht

Dutasteride is a synthetic compound classified as a 4-azasteroid. It is not an endogenous hormone but is chemically synthesized for therapeutic use. Dutasteride is primarily produced in pharmaceutical laboratories and is categorized under hormone management drugs due to its role in modulating androgen levels. Researchers have found that dutasteride is a potent inhibitor of the enzyme 5-α-reductase, which is responsible for the conversion of testosterone to dihydrotestosterone (DHT), a more potent androgen. This inhibition is crucial in conditions like androgenetic alopecia (AGA) and benign prostatic hyperplasia (BPH), where elevated DHT levels contribute to disease pathogenesis. Dutasteride's primary physiological role is in the management of conditions associated with excessive DHT production. It is extensively researched for its efficacy in treating AGA, a common form of hair loss, and BPH, a condition characterized by prostate enlargement. Researchers have observed that dutasteride effectively reduces DHT levels in the serum and scalp, thereby mitigating the progression of hair follicle miniaturization in AGA and alleviating symptoms of BPH. The mechanism of action of dutasteride involves the competitive inhibition of both type-1 and type-2 isoenzymes of 5-α-reductase. This dual inhibition leads to a significant reduction in DHT levels, which in turn decreases the androgenic effects on hair follicles and prostate tissue. Pharmacokinetically, dutasteride has a long plasma half-life of approximately 5 weeks, indicating prolonged activity after administration. It is metabolized primarily in the liver and has a high oral bioavailability. Clinically, dutasteride is approved for the treatment of BPH but is also used off-label for AGA. It is approved for AGA in some countries like Japan and South Korea. However, its use is associated with potential sexual and neuropsychiatric side effects, necessitating careful consideration in clinical practice.

Chemical profile

Chemische Struktur

Chemical structure of Dutasteride
FormelC27H30F6N2O2
Molekulargewicht528.5g/mol
CAS-Nummer164656-23-9
PubChem CID6918296
Mechanism

Wirkmechanismus

Dutasteride acts by inhibiting the 5-α-reductase enzyme, specifically targeting both type-1 and type-2 isoenzymes. This inhibition reduces the conversion of testosterone to dihydrotestosterone (DHT), thereby decreasing the androgenic effects on tissues sensitive to DHT, such as hair follicles and prostate tissue.

Mechanism

Signalweg

Dutasteride acts as a selective and competitive inhibitor of both type I and type II isoenzymes of 5α-reductase, thereby reducing the conversion of testosterone to dihydrotestosterone (DHT), a potent androgen that activates androgen receptor signaling pathways implicated in androgenetic alopecia. By decreasing DHT levels in serum and scalp, dutasteride mitigates the biological processes associated with hair follicle miniaturization and promotes hair regrowth. The precise downstream signaling pathways affected by this inhibition are not fully understood, but they likely involve modulation of the androgen receptor and related gene expression pathways.

Half-Life & Pharmacokinetics

POOral

Plasma half-life ~5 weeks

Dutasteride has a long half-life due to its high lipophilicity and extensive tissue distribution.

Storage

Temperature

Store at room temperature (15-30C)

Light

Protect from light

Form

Stable in capsule form

Notes

Keep in a tightly closed container to protect from moisture.

Solubility

Löslichkeit

Dutasteride is poorly soluble in water but soluble in organic solvents like ethanol and methanol.

Legal Status

🇩🇪DE

Prescription only (verschreibungspflichtig), not a controlled substance.

🇺🇸US

FDA approved for BPH, prescription required, not a controlled substance.

🇦🇺AU

Prescription only medicine (S4).

🇬🇧UK

Prescription only medicine (POM), approved for BPH.

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 long-term safety and efficacy of dutasteride for androgenetic alopecia, particularly in diverse populations and those with varying underlying health conditions. Further research is needed to establish standardized treatment protocols, including optimal dosing and administration methods, such as topical formulations and combination therapies, to minimize adverse effects. Additionally, larger randomized controlled trials are necessary to clarify the incidence and mechanisms of sexual and neuropsychiatric side effects associated with dutasteride compared to finasteride.

57 Research Publications

2,161

Total Citations

29

Human/RCT

5.9

Avg. Influence

2025

Latest

Sort
Filter
#01

The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study.

HumanInfluence42.0
753
Researchers observed that combination therapy with dutasteride and tamsulosin significantly improves clinical outcomes in men with benign prostatic hyperplasia compared to monotherapy.
#02

The importance of dual 5alpha-reductase inhibition in the treatment of male pattern hair loss: results of a randomized placebo-controlled study of dutasteride versus finasteride.

HumanInfluence23.0
296
The study demonstrated that dutasteride increases hair count in men with male pattern hair loss, showing superior efficacy compared to finasteride.
#03

A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with androgenetic alopecia.

Gubelin Harcha Walter, et al. · Journal of the American Academy of Dermatology · 2014

HumanInfluence14.0
170
The study demonstrated that dutasteride significantly increased hair count and width in men with androgenetic alopecia compared to finasteride and placebo after 24 weeks.

Key findings

  1. 01Dutasteride at 0.5 mg/d led to greater hair growth than both finasteride and placebo.
  2. 02Hair count and width increased with higher doses of dutasteride.
  3. 03The treatment was well tolerated with similar adverse events across all groups.
#04

Clinical outcomes after combined therapy with dutasteride plus tamsulosin or either monotherapy in men with benign prostatic hyperplasia (BPH) by baseline characteristics: 4-year results from the randomized, double-blind Combination of Avodart and Tamsulosin (CombAT) trial.

HumanInfluence8.0
102
Researchers observed that combined therapy with dutasteride and tamsulosin significantly reduced the risk of acute urinary retention and clinical progression compared to tamsulosin alone in men with benign prostatic hyperplasia.
#05

Adverse Sexual Effects of Treatment with Finasteride or Dutasteride for Male Androgenetic Alopecia: A Systematic Review and Meta-analysis.

Lee Solam, et al. · Acta dermato-venereologica · 2019

ReviewInfluence5.0
70
Researchers observed a 1.57-fold increased risk of sexual dysfunction in humans treated with 5α-reductase inhibitors, with dutasteride showing a non-significant increase compared to finasteride.

Key findings

  1. 01Finasteride increases the risk of sexual dysfunction by 66%.
  2. 02Dutasteride also carries a risk, but the evidence is less certain.
  3. 03Further research is needed to clarify the effects of dutasteride.
#06

Dutasteride in Androgenetic Alopecia: An Update.

Arif Tasleem, et al. · Current clinical pharmacology · 2017

ReviewInfluence5.0
68
Researchers observed that dutasteride is an effective treatment option for androgenetic alopecia in humans, showing superior efficacy compared to finasteride with similar adverse effects.

Key findings

  1. 01Dutasteride effectively inhibits the enzyme responsible for hair loss.
  2. 02It has shown better results than finasteride in clinical trials.
  3. 03Dutasteride has comparable side effects to finasteride.
#07

Dual-5α-Reductase Inhibition Promotes Hepatic Lipid Accumulation in Man.

HumanInfluence1.0
64
Researchers observed that dutasteride increased hepatic lipid accumulation and insulin resistance in healthy male volunteers, indicating potential metabolic effects of dual 5α-reductase inhibition.
#08

The efficacy and safety of dutasteride compared with finasteride in treating men with androgenetic alopecia: a systematic review and meta-analysis.

ReviewInfluence5.0
64
The study demonstrated that dutasteride is more effective than finasteride for increasing hair count in men with androgenetic alopecia, with similar rates of sexual side effects.
#09

The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study.

HumanInfluence2.0
60
The study demonstrated that combined therapy with dutasteride and tamsulosin provided superior long-term control of both storage and voiding lower urinary tract symptoms compared to monotherapy in men with benign prostatic hyperplasia.
#10

Health Risks Associated with Long-Term Finasteride and Dutasteride Use: It's Time to Sound the Alarm.

Traish Abdulmaged M · The world journal of men's health · 2020

ReviewInfluence1.0
55
Researchers observed that long-term use of finasteride and dutasteride may be associated with various health risks, including metabolic dysfunctions in humans.

Key findings

  1. 01Long-term use of finasteride and dutasteride may cause non-alcoholic fatty liver disease (NAFLD).
  2. 02These medications could contribute to insulin resistance and type 2 diabetes.
  3. 03Users may experience dry eye disease and potential kidney dysfunction.

Clinical Trials (56)

Preclinical
Phase I
Phase II
Phase III
Approved

56

Total Trials

17,896

Total Enrolled

Drug Use Investigation for AVOLVE(BPH)

NCT01376284COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

1,000

Started

2010

Primary outcome

The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules

Prostatic Hyperplasia

Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP

NCT07417449RECRUITING
Sponsor

Ankara City Hospital Bilkent

Enrollment

1,000

Started

2026

Primary outcome

Change in Hemoglobin Levels (Hemoglobin Drop)

Prostatic Hyperplasia, Benign

AVODART® Alopecia Post-marketing Surveillance (PMS)

NCT01004809COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

712

Started

2010

Primary outcome

Occurrence of adverse event after dutasteride administration

Alopecia

Response of Patients on Surveillance for Prostate Cancer to Dutasteride

NCT01525914COMPLETED
Sponsor

Sunnybrook Health Sciences Centre

Enrollment

100

Started

2010

Primary outcome

change in serum PSA

Prostate Cancer

Pharmacogenetics of Alcohol: Treatment Implications

NCT00734656COMPLETED
Sponsor

UConn Health

Enrollment

94

Started

2007

Primary outcome

Breath Alcohol

Alcohol Related DisordersAlcoholismAlcohol Abuse

Metabolic Effects of Steroids in Obese Men

Sponsor

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

Enrollment

57

Started

2005

Primary outcome

insulin sensitivity

ObesityInsulin Resistance

Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects

NCT00802321COMPLETED
Sponsor

UConn Health

Enrollment

40

Started

2006

Primary outcome

Change in 5AR enzyme activity as measured by the DHT/testosterone ratio and levels of 3a-androstanediol glucuronide as a function of time after a single loading dose of dutasteride.

Alcohol Related DisordersAlcoholismAlcohol Abuse

MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer

NCT00706966COMPLETED
Sponsor

University of California, San Francisco

Enrollment

10

Started

2005

Primary outcome

Change in Extent of Cancer

Nonmalignant NeoplasmProstate Cancer

Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement

NCT01294592Phase 4COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

742

Started

2010

Primary outcome

Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach

Prostatic Hyperplasia

Prospective Sexual Function Study for BPH Subjects

NCT01777269Phase 4COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

489

Started

2013

Primary outcome

Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months

Prostatic Hyperplasia

Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

NCT00363311Phase 4COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

302

Started

2006

Primary outcome

Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression

Neoplasms, Prostate

Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter

NCT00421421Phase 4TERMINATED
Sponsor

GlaxoSmithKline

Enrollment

276

Started

2007

Primary outcome

Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period

Benign Prostatic Hyperplasia

Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

NCT00470834Phase 4COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

127

Started

2007

Primary outcome

Time to Disease Progression

Neoplasms, Prostate

Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia

NCT01673490Phase 4TERMINATED
Sponsor

GlaxoSmithKline

Enrollment

59

Started

2012

Primary outcome

Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs

Prostatic Hyperplasia

TRADE-Testosterone Replacement and Dutasteride Effectiveness

NCT00194675Phase 4COMPLETED
Sponsor

University of Washington

Enrollment

53

Started

2005

Primary outcome

Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.

HypogonadismBenign Prostatic Hyperplasia

Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

NCT00062790Phase 4COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

50

Started

2003

Primary outcome

Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).

Prostatic Hyperplasia

A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart

NCT00690950Phase 4UNKNOWN
Sponsor

Urologic Consultants of Southeastern PA

Enrollment

50

Started

2008

Primary outcome

Laboratory parameters: including serum testosterone, DHT level and PSA

Benign Prostatic Hyperplasia

Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)

NCT00939120Phase 4COMPLETED
Sponsor

Siami, Paul F., M.D.

Enrollment

46

Started

2009

Primary outcome

Post-void Residual (PVR) Volume

Benign Prostatic Hyperplasia (BPH)

Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer

NCT00375765Phase 4COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

40

Started

2005

Primary outcome

Relative change in PSA(Prostate-specific antigen)expression per cell at 3 months

Benign Prostatic HyperplasiaProstate Cancer

Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction

NCT00827814Phase 4COMPLETED
Sponsor

Samsung Medical Center

Enrollment

36

Started

2006

Primary outcome

Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW)

Benign Prostatic Hyperplasia

Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement

NCT00752869Phase 4COMPLETED
Sponsor

The Miriam Hospital

Enrollment

24

Started

2008

Primary outcome

PSA reduction

Hypogonadism

"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

NCT00056407Phase 3COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

8,231

Started

2003

Primary outcome

Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)

Neoplasms, Prostate

Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

NCT04947631Phase 3COMPLETED
Sponsor

Dongkook Pharmaceutical Co., Ltd.

Enrollment

667

Started

2021

Primary outcome

Change in Total International Prostate Symptom Score (IPSS) from baseline to Week 48

Benign Prostatic Hyperplasia

Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

NCT02058368Phase 3COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

607

Started

2014

Primary outcome

Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months

Prostatic Hyperplasia

Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

NCT00398281Phase 3COMPLETED
Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Enrollment

450

Started

2006

Primary outcome

Efficacy of short-term dutasteride in improving prostate cancer detection

Prostate Cancer

Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

NCT00368979Phase 3COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

378

Started

2006

Primary outcome

Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52

Prostatic Hyperplasia

Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer

NCT00244309Phase 3COMPLETED
Sponsor

Case Comprehensive Cancer Center

Enrollment

348

Started

2005

Primary outcome

AUA score will be used to assess severity of urinary symptoms. All patients will be contacted weekly by telephone for 12 weeks then monthly postoperatively to get their AUA score. A total of 21 AUA scores postoperatively.

Prostate Cancer

Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

NCT00527605Phase 3COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

253

Started

2007

Primary outcome

Percent Change From Baseline in the Prostate Volume at Month 6

Benign Prostatic HyperplasiaProstatic Hyperplasia

A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

NCT00441116Phase 3COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

153

Started

2006

Primary outcome

Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.

Alopecia

A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia

NCT01831791Phase 3COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

120

Started

2013

Primary outcome

Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)

Alopecia

Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

NCT02014584Phase 3COMPLETED
Sponsor

Stiefel, a GSK Company

Enrollment

117

Started

2014

Primary outcome

Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period

Alopecia

Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen

NCT04545450Phase 3COMPLETED
Sponsor

Unita Complessa di Ostetricia e Ginecologia

Enrollment

16

Started

2008

Primary outcome

Change in isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF)

TransgenderismHypogonadism

Testosterone and Its Metabolites in GID

NCT00146146Phase 3COMPLETED
Sponsor

Unita Complessa di Ostetricia e Ginecologia

Enrollment

15

Started

2005

Primary outcome

bone metabolism

Transsexualism

ARTS - AVODART After Radical Therapy For Prostate Cancer Study

NCT00558363Phase 2COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

294

Started

2007

Primary outcome

Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)

Neoplasms, ProstateProstate Cancer After a Radical Treatment

Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer

NCT07420517Phase 2RECRUITING
Sponsor

Paul Toren

Enrollment

95

Started

2026

Primary outcome

Incidence of NMIBC recurrences in patients treated with dutasteride

Bladder Cancer

Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy

NCT00866554Phase 2COMPLETED
Sponsor

CHU de Quebec-Universite Laval

Enrollment

60

Started

2009

Primary outcome

Total prostate volume

Prostate CancerErectile DysfunctionLower Urinary Tract Symptoms

Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.

NCT05599243Phase 2COMPLETED
Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Enrollment

45

Started

2022

Primary outcome

Safety and Tolerability

Male Androgenetic Alopecia

28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men

NCT00398580Phase 2COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

43

Started

2006

Primary outcome

Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine

HypogonadismHypogonadism, Male

Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

NCT01393730Phase 2COMPLETED
Sponsor

Mary-Ellen Taplin, MD

Enrollment

40

Started

2011

Primary outcome

Number of Participants With Androgen Receptor (AR) Related Mutations

Prostate Cancer

Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

NCT00403000Phase 2COMPLETED
Sponsor

Roswell Park Cancer Institute

Enrollment

27

Started

2004

Primary outcome

Time to disease progression

Prostate Cancer

Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer

NCT00668642Phase 2COMPLETED
Sponsor

Endeavor Health

Enrollment

20

Started

2007

Primary outcome

Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.

Prostate Cancer

Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone

NCT00161421Phase 2COMPLETED
Sponsor

University of Washington

Enrollment

18

Started

2005

Primary outcome

Elevations in serum testosterone

ContraceptionHypogonadism

Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

NCT00985738Phase 2TERMINATED
Sponsor

University of Colorado, Denver

Enrollment

16

Started

2009

Primary outcome

To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.

Prostate Cancer

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

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

NCT00953576Phase 1/2TERMINATED
Sponsor

Dana-Farber Cancer Institute

Enrollment

11

Started

2009

Primary outcome

Lapatinib Maximum Tolerated Dose (MTD) [Phase I]

Prostate Cancer

A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.

NCT01254071Phase 1COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

86

Started

2010

Primary outcome

1. To investigate the bioavailability of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.2 mg relative to concomitant dosing of dutasteride 0.5 mg capsules and tamsulosin 0.2 mg tablets in the fed and fasted states.

Prostatic Hyperplasia

Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia

NCT07065682Phase 1RECRUITING
Sponsor

Universitas Diponegoro

Enrollment

84

Started

2023

Primary outcome

Uroflowmetry result

BPH (Benign Prostatic Hyperplasia)

Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men

NCT00309855Phase 1COMPLETED
Sponsor

Mayo Clinic

Enrollment

80

Started

2005

Primary outcome

Growth Hormone concentration after injections

Aging

A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia

NCT01495026Phase 1COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

63

Started

2011

Primary outcome

Relative bioavailability of tamsulosin from FDC products (0.5 mg dutasteride /0.2 mg tamsulosin HCl) containing a size 3-oblong dutasteride soft gel capsule and tamsulosin pellets having a range of tamsulosin release rates produced by different mixtures

Prostatic Hyperplasia

Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects

NCT02509104Phase 1COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

56

Started

2015

Primary outcome

Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin

Prostatic Hyperplasia

Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride

NCT01942551Phase 1COMPLETED
Sponsor

Dongkook Pharmaceutical Co., Ltd.

Enrollment

47

Started

2013

Primary outcome

Area Under Curve (AUC) of tadalafil

Benign Prostate Hyperplasia

Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects

NCT02578953Phase 1COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

36

Started

2015

Primary outcome

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) of dutasteride test product and reference product

Prostatic Hyperplasia

Dutasteride to Treat Women With Menstrually Related Mood Disorders

NCT00082043Phase 1COMPLETED
Sponsor

National Institute of Mental Health (NIMH)

Enrollment

34

Started

2004

Primary outcome

Rating Scale for Premenstrual Tension (PMTS); Daily symptom rating form (DRF); Visual Analogue Symptom (VAS) self-rating form.

Premenstrual SyndromePMSHealthyDepression

Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule

NCT06233227Phase 1UNKNOWN
Sponsor

Bio-innova Co., Ltd

Enrollment

28

Started

2024

Primary outcome

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) of dutasteride test product and reference product

Healthy Subjects

This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples

NCT01957189Phase 1COMPLETED
Sponsor

GlaxoSmithKline

Enrollment

24

Started

2013

Primary outcome

To evaluate the pharmacokinetics of dutasteride and tamsulosin when dosed alone and in combination

Prostatic Hyperplasia

Study of PCUR-101 in Combination With ADT in Patients With mCRPC

NCT04677855Phase 1TERMINATED
Sponsor

Pellficure Pharmaceuticals, Inc

Enrollment

7

Started

2021

Primary outcome

Occurrence of Dose Limiting Toxicity

Prostate Cancer

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