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Hormone · Profile

Estradiol

E2 · 17β-Estradiol · Estradiol Valerate · Estrofem

Sex Hormones & TRTApproved
MW
272.4g/mol
Formula
C18H24O2

Estradiol, specifically 17β-estradiol (E2), is a steroid hormone primarily produced in the ovaries, but also synthesized in the brain and other tissues, playing a crucial role in various physiological processes. Researchers primarily study E2 for its significant effects on reproductive health, neuroplasticity, and its involvement in conditions like osteoporosis and acute lung injury. Key findings indicate that E2 induces synaptic rearrangements in brain regions associated with learning and memory, while also promoting mitochondrial biogenesis and function in the context of lung injury. Additionally, studies suggest that E2 enhances the migration of macrophages to injured tissues, facilitating inflammation resolution and tissue repair. Current research continues to explore E2's multifaceted roles, highlighting its potential therapeutic implications in various health conditions.

Overview

Übersicht

Estradiol, also known as 17β-Estradiol or E2, is an endogenous steroid hormone primarily produced in the ovaries, with additional synthesis occurring in the brain and adipose tissue. It belongs to the class of estrogens, which are key sex hormones involved in the regulation of the female reproductive system and secondary sexual characteristics. Estradiol is also available in synthetic forms, such as estradiol valerate, for therapeutic use. Researchers have extensively studied estradiol for its role in various physiological processes and its potential therapeutic applications. It plays a critical role in neuroplasticity, influencing synaptic rearrangements in brain regions associated with learning and memory, such as the cortex and hippocampus. Estradiol is also implicated in the modulation of mitochondrial function, particularly in the context of acute lung injury and inflammation resolution. The hormone's mechanism of action involves binding to estrogen receptors, primarily ERα and ERβ, and activating genomic and non-genomic pathways. These pathways include the p38 MAPK pathway, which is involved in matrix mineralization and may have therapeutic implications for conditions like osteoporosis. Estradiol's pharmacokinetic properties vary depending on the form and route of administration. Endogenously, it has a circulating half-life of approximately 70 minutes. When administered orally, its bioavailability is limited due to first-pass metabolism, whereas transdermal and injectable forms offer more stable pharmacokinetic profiles. Clinically, estradiol is used in hormone replacement therapy, particularly for menopausal symptoms, and is regulated as a prescription medication in many countries. Researchers continue to explore its broader therapeutic potential in various medical conditions, including neurodegenerative diseases and inflammatory disorders.

Chemical profile

Chemische Struktur

Chemical structure of Estradiol
FormelC18H24O2
Molekulargewicht272.4g/mol
CAS-Nummer50-28-2
PubChem CID5757
Mechanism

Wirkmechanismus

Estradiol acts primarily on estrogen receptors ERα and ERβ, initiating a cascade of genomic and non-genomic events. This includes the activation of the p38 MAPK pathway, which influences processes such as matrix mineralization and mitochondrial biogenesis, contributing to its diverse physiological effects.

Mechanism

Signalweg

Estradiol (E2) primarily exerts its effects through estrogen receptors (ERα and ERβ), activating both genomic and nongenomic signaling pathways. Key pathways involved include the p38 MAPK pathway and the PGC-1β/Nrf2/TFAM signaling cascade, which mediate processes such as synaptic plasticity, mitochondrial biogenesis, and matrix mineralization. While the mechanisms of E2 action are well-documented in certain contexts, some aspects remain incompletely understood, particularly regarding its interactions with other synaptic modulators and the full spectrum of its biological effects.

Half-Life & Pharmacokinetics

ENEndogenous

Circulating half-life ~70 minutes

TDTransdermal

Steady-state after 24-48h

POOral

Poor bioavailability due to first-pass

Estradiol valerate and other esters may have different pharmacokinetic profiles, with longer half-lives in injectable forms.

Storage

Temperature

Store at room temperature (15-30C)

Light

Protect from light

Form

Oil solution stable for 2+ years

Notes

Ensure containers are tightly closed to prevent contamination.

Solubility

Löslichkeit

Estradiol is poorly soluble in water but soluble in ethanol and oils, which is relevant for its formulation in various delivery systems.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription only); not listed under BtMG.

🇺🇸US

FDA-approved for hormone replacement therapy; prescription required.

🇦🇺AU

TGA Schedule 4 (prescription only medicine).

🇬🇧UK

Prescription only medicine (POM); 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 long-term effects of estradiol on neuroplasticity and synaptic rearrangements, particularly in diverse populations and across different age groups. Further research is needed to clarify the mechanisms by which estradiol mediates mitochondrial function in acute lung injury, especially in human subjects, as most studies have been conducted in animal models. Additionally, the role of estradiol in modulating macrophage activity in endometrial repair requires more extensive investigation, including randomized controlled trials that assess the impact of estradiol on inflammation resolution in various clinical contexts.

136 Research Publications

2,778

Total Citations

24

Human/RCT

1.8

Avg. Influence

2025

Latest

Sort
Filter
#01

Ethinyl estradiol and 17β-estradiol in combined oral contraceptives: pharmacokinetics, pharmacodynamics and risk assessment.

ReviewInfluence8.0
193
The review highlighted that 17β-Estradiol-based combined oral contraceptives demonstrate similar efficacy and cycle control as ethinyl estradiol formulations while reducing health risks.
#02

17β-Estradiol Directly Lowers Mitochondrial Membrane Microviscosity and Improves Bioenergetic Function in Skeletal Muscle.

AnimalInfluence7.0
154
The study demonstrated that 17β-estradiol administration restored mitochondrial function and insulin sensitivity in skeletal muscle of ovariectomized mice by modulating membrane properties and bioenergetics.
#03

Estrogen neuroprotection and the critical period hypothesis.

ReviewInfluence8.0
140
Researchers observed that 17β-Estradiol provides neuroprotection during a critical period, with implications for neurological health following menopause.
#04

Influence of microplastics occurrence on the adsorption of 17β-estradiol in soil.

In VitroInfluence2.0
101
The study demonstrated that microplastics in soil enhance the adsorption capacity of 17β-estradiol, potentially reducing its mobility in the environment.
#05

Luminescence-Sensing Tb-MOF Nanozyme for the Detection and Degradation of Estrogen Endocrine Disruptors.

In Vitro
89
Researchers observed that a luminescence-sensing Tb-MOF nanozyme can effectively detect and degrade 17β-estradiol at concentrations as low as 50 pM.
#06

Effects of 17β-estradiol (E2) on aqueous organisms and its treatment problem: a review.

Review
88
Researchers observed that traditional wastewater treatment processes inadequately remove 17β-estradiol, leading to its persistent presence in aquatic environments.
#07

Role of 17β-estradiol and testosterone in apoptosis.

Vasconsuelo Andrea, et al. · Steroids · 2011

ReviewInfluence2.0
86
The study demonstrated that 17β-estradiol (E2) and testosterone (T) protect against apoptosis in various tissues by modulating mitochondrial functions and signaling pathways.

Key findings

  1. 01E2 and T affect growth and cell functions in many organs beyond the reproductive system.
  2. 02Both hormones can activate signaling pathways quickly, influencing cell survival.
  3. 03E2 and T primarily protect mitochondria, contributing to their anti-apoptotic effects.
#08

Membrane association of estrogen receptor alpha and beta influences 17beta-estradiol-mediated cancer cell proliferation.

In VitroInfluence1.0
84
Researchers observed that S-palmitoylation of estrogen receptors influences their membrane localization and distinct signaling pathways in response to 17β-Estradiol.
#09

17β-Estradiol and testosterone in sarcopenia: Role of satellite cells.

ReviewInfluence1.0
68
The review summarized that 17β-estradiol and testosterone regulate satellite cell activation, which is crucial for skeletal muscle regeneration in the elderly, potentially addressing sarcopenia.
#10

A critical and comprehensive review of the current status of 17β-estradiol hormone remediation through adsorption technology.

Review
65
The review highlighted various adsorption technologies for remediating 17β-estradiol in water, emphasizing the need for advanced treatment systems to mitigate its ecological impact.

Clinical Trials (63)

Preclinical
Phase I
Phase II
Phase III
Approved

63

Total Trials

20,410

Total Enrolled

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

NCT00042289COMPLETED
Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

1,578

Started

2003

Primary outcome

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs

HIV Infections

A RCT Comparing Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in FET

NCT02197208COMPLETED
Sponsor

The University of Hong Kong

Enrollment

300

Started

2014

Primary outcome

ongoing pregnancy rate

SubfertilityPregnancy

Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

NCT05802303TERMINATED
Sponsor

Indira IVF Hospital Pvt Ltd

Enrollment

172

Started

2023

Primary outcome

Endometrial thickness (ET)

Frozen Embryo TransferInfertility, Female

Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

NCT02400801COMPLETED
Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

166

Started

2013

Primary outcome

clinical pregnancy rate per initiated ART cycle

EndometriosisInfertility

The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis

Sponsor

Beijing Obstetrics and Gynecology Hospital

Enrollment

100

Started

2017

Primary outcome

Incidence of adhesion information

Intrauterine Adhesion

Estradiol and Stress Reactivity in Women

Sponsor

International Research Training Group 2804

Enrollment

74

Started

2024

Primary outcome

Associations between elevated E2 concentration and acute stress effects on subjective experience

Stress vs. ControlEstradiol vs. Placebo

Timing Estrogen After MenoPaUSe

NCT01605071COMPLETED
Sponsor

University of Colorado, Denver

Enrollment

53

Started

2011

Primary outcome

Insulin-mediated Glucose Disposal Rate (Hyperinsulinemic-euglycemic Clamp)

Insulin Resistance

Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.

NCT01519401COMPLETED
Sponsor

Catholic University of the Sacred Heart

Enrollment

50

Started

2010

Primary outcome

To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women

Polycystic Ovary SyndromeEstro-progestin Drugs

"Effect of CPA/EE Drug on Periodontal Tissue and hsCRP Levels in PCOS Patients With Gingivitis

NCT05657171COMPLETED
Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Enrollment

47

Started

2022

Primary outcome

Bleeding on probing (BOP)

Periodontal Diseases

Phlebotomy and Polycystic Ovary Syndrome

NCT02460445COMPLETED
Sponsor

Manuel Luque Ramírez

Enrollment

37

Started

2015

Primary outcome

Change in the Matsuda index from the circulating glucose and insulin concentrations during and standard oral glucose tolerance test.

HyperandrogenismMetabolic Cardiovascular Syndrome

Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Enrollment

26

Started

2011

Primary outcome

flow-mediated dilation

Polycystic Ovary SyndromeEndothelial Dysfunction

Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

NCT04301934COMPLETED
Sponsor

Mayo Clinic

Enrollment

12

Started

2020

Primary outcome

Prevalence of Urinary Tract Infections (UTI)

Urinary Tract Infections

Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women

NCT01633814TERMINATED
Sponsor

University of Missouri-Columbia

Enrollment

4

Started

2011

Primary outcome

Change in Carotid Baroreflex Sensitivity (Bpm/mmHg)

MenopauseAgingBlood Pressure

Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)

NCT00431093Phase 4COMPLETED
Sponsor

Organon and Co

Enrollment

570

Started

2002

Primary outcome

For the bleeding evaluation, subject will be given a diary card to record the days on which no bleeding, vaginal spotting or bleeding occurs

Menopause

A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women

NCT00860964Phase 4COMPLETED
Sponsor

Peking Union Medical College

Enrollment

221

Started

1998

Primary outcome

Bone mineral density

Osteoporosis

Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives, Correction by Antioxidants

NCT02027337Phase 4UNKNOWN
Sponsor

Tyumen State Medical Academy

Enrollment

200

Started

2013

Primary outcome

Change from Baseline in Activated recalcification time

Polycystic Ovarian SyndromeHyperandrogenismMenstrual Irregularities

Postpartum Vaginal Estrogen for Breastfeeding Patients

NCT05457972Phase 4RECRUITING
Sponsor

University Hospitals Cleveland Medical Center

Enrollment

100

Started

2025

Primary outcome

Total Female Sexual Function Index (FSFI) score

BreastfeedingPostpartum Sexual DysfunctionVaginal Atrophy

Cardiometabolic Consequences of the Loss of Ovarian Function

NCT06264882Phase 4RECRUITING
Sponsor

University of Colorado, Denver

Enrollment

100

Started

2024

Primary outcome

Brachial artery flow mediated dilation (FMD)

MenopauseEstrogen DeficiencyAgingAdiposity

Vaginal Estrogen for Asymptomatic Microscopic Hematuria

NCT03033160Phase 4UNKNOWN
Sponsor

Boston Urogynecology Associates

Enrollment

68

Started

2016

Primary outcome

Comparison of microscopic hematuria (RBC's) at 12 weeks compared to baseline measurement

Asymptomatic Microscopic Hematuria

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

NCT00640224Phase 4COMPLETED
Sponsor

Silva Arslanian

Enrollment

65

Started

2005

Primary outcome

Peripheral Insulin Sensitivity at Baseline and 6 Months.

Polycystic Ovary Syndrome

Bioenergetic Effects of Aging and Menopause (BEAM)

NCT04043520Phase 4RECRUITING
Sponsor

University of Colorado, Denver

Enrollment

57

Started

2019

Primary outcome

Change in the Microdialysis Cortisone Challenge (MCC) Index

MenopauseObesity, AbdominalAgingWeight Gain

Efficacy and Tolerability of Angeliq in Thai Women

NCT00185328Phase 4COMPLETED
Sponsor

Bayer

Enrollment

55

Started

2005

Primary outcome

The relative change in the frequency of hot flushes

Postmenopause

Impact of Combined Hormonal Contraceptives on UPA

NCT02577601Phase 4COMPLETED
Sponsor

Oregon Health and Science University

Enrollment

36

Started

2015

Primary outcome

Number of Participants With Follicle Rupture

Contraception

Sex Steroids and the Serotonin Transporter

NCT01065220Phase 4COMPLETED
Sponsor

Medical University of Vienna

Enrollment

32

Started

2010

Primary outcome

change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography

Transsexualism

Prostate Adenocarcinoma TransCutaneous Hormones

NCT00303784Phase 3UNKNOWN
Sponsor

University College, London

Enrollment

2,200

Started

2006

Primary outcome

Progression-Free Survival

AnemiaCardiovascular ComplicationsHot FlashesOsteoporosisProstate Cancer

Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)

NCT02616146Phase 3TERMINATED
Sponsor

Organon and Co

Enrollment

2,016

Started

2015

Primary outcome

Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)

Contraception

Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ

NCT00567164Phase 3COMPLETED
Sponsor

Bayer

Enrollment

1,887

Started

2007

Primary outcome

Pearl Index

ContraceptionOvulation InhibitionContraceptives, Oral

Study of Safety and Efficacy of an Oral Contraceptive

NCT00477633Phase 3COMPLETED
Sponsor

Warner Chilcott

Enrollment

1,700

Started

2007

Primary outcome

Pearl Index, 18-35 Years, MITT Population

Contraception

A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon.

NCT00236782Phase 3COMPLETED
Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Enrollment

1,517

Started

1997

Primary outcome

Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.

Contraception

Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer

NCT00003771Phase 3COMPLETED
Sponsor

Regional Oncologic Center

Enrollment

1,300

Started

1997

Breast CancerMenopausal Symptoms

Study of Safety and Efficacy of an Oral Contraceptive

NCT00932321Phase 3COMPLETED
Sponsor

Warner Chilcott

Enrollment

938

Started

2004

Primary outcome

Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population

Prevention of Pregnancy

SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

NCT03654274Phase 3COMPLETED
Sponsor

Myovant Sciences GmbH

Enrollment

802

Started

2018

Primary outcome

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52

Endometriosis

Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

NCT00446199Phase 3COMPLETED
Sponsor

Bayer

Enrollment

735

Started

2007

Primary outcome

Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)

Vasomotor SymptomsHot Flashes

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

NCT03213457Phase 3COMPLETED
Sponsor

AbbVie

Enrollment

681

Started

2017

Primary outcome

Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment

Endometriosis

Comparative Trial in Hormone Withdrawal Associated Symptoms

NCT01076582Phase 3COMPLETED
Sponsor

Bayer

Enrollment

592

Started

2010

Primary outcome

Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales).

Oral Contraceptive

Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization

NCT03788681Phase 3UNKNOWN
Sponsor

Ain Shams University

Enrollment

170

Started

2018

Primary outcome

live birth rate

ICSI

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

NCT04232813Phase 3COMPLETED
Sponsor

Instituto Palacios

Enrollment

120

Started

2020

Primary outcome

Vulvovaginal Symptoms

Vulvovaginal Atrophy

Prevention of Obesity in Women Via Estradiol Regulation

NCT00687739Phase 3COMPLETED
Sponsor

University of Colorado, Denver

Enrollment

79

Started

2008

Primary outcome

Resting Energy Expenditure (REE)

Obesity

Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy

NCT06969326Phase 3RECRUITING
Sponsor

Women and Infants Hospital of Rhode Island

Enrollment

48

Started

2025

Primary outcome

Evaluate the efficacy of one-time topical estrogen application for reducing postoperative health system contacts for vaginal bleeding in the first two weeks post hysterectomy.

Postoperative BleedingGender DysphoriaHysterectomy

Oestradiol Supplementation in Luteal Long Agonist Fresh In Vitro Fertilization/Intra Cytoplasmic Sperm Injection ( IVF/ICSI) Cycle .

NCT03832894Phase 3UNKNOWN
Sponsor

Cairo University

Enrollment

2

Started

2018

Primary outcome

Implantation rate

Infertility

Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2

NCT01221831Phase 2COMPLETED
Sponsor

Estetra

Enrollment

396

Started

2010

Primary outcome

Recording of vaginal bleeding events (diary) as a measure of Cycle control

Contraception

Study of Bleeding With Extended Administration of an Oral Contraceptive

NCT00338052Phase 2COMPLETED
Sponsor

Warner Chilcott

Enrollment

207

Started

2006

Primary outcome

Number of bleeding/spotting days/episodes per treatment cycle

Contraception

Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

NCT05472779Phase 2COMPLETED
Sponsor

Stephanie Wang Zuo

Enrollment

114

Started

2023

Primary outcome

Percentage of participants who are UTI-free at 6 months

Recurrent Urinary Tract Infection

A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles

NCT00631124Phase 2COMPLETED
Sponsor

Bayer

Enrollment

103

Started

2008

Primary outcome

The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no

Contraception

TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy

NCT02449902Phase 2COMPLETED
Sponsor

TherapeuticsMD

Enrollment

50

Started

2013

Primary outcome

Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells)

MenopauseVulvovaginal AtrophyPainful IntercourseDyspareunia

Analysis of the Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women

NCT07754630Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Nutrindo Ideais Research Center

Enrollment

50

Started

2025

Primary outcome

hormonal implant and PENTRAVAN transdermal gel pharmacokinetics

MenopauseHypoestrogenismHormonal Therapy

Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism

NCT00004763Phase 2COMPLETED
Sponsor

National Center for Research Resources (NCRR)

Enrollment

45

Started

1993

Hyperandrogenism

Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

NCT02475265Phase 2COMPLETED
Sponsor

Massachusetts General Hospital

Enrollment

11

Started

2015

Primary outcome

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)

Anorexia NervosaOsteoporosis

Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives

NCT00089414Phase 2TERMINATED
Sponsor

National Institute of Mental Health (NIMH)

Enrollment

5

Started

2004

Primary outcome

Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.

Premenstrual SyndromePMSPremenstrual Dysphoric DisorderPMDDDepression

Maternal Mental Health Trial

NCT04685148Phase 1/2RECRUITING
Sponsor

Vibe G Frøkjær, MD, PhD

Enrollment

220

Started

2021

Primary outcome

Number of participants with Major Depression Disorder

Major Depressive DisorderPostpartum Depression

A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.

NCT00709332Phase 1COMPLETED
Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Enrollment

47

Started

2005

Primary outcome

Evaluate the pharmacokinetic drug interaction between folic acid and OC (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown products of NGM, (norelgestromin [NGMN], and norgestrel [NG]) and EE.

Drug InteractionsContraceptionPharmacokinetics

Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product

NCT05282940Phase 1COMPLETED
Sponsor

Laboratorios Andromaco S.A.

Enrollment

36

Started

2022

Primary outcome

Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)

Therapeutic Equivalency

Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®

NCT06233071Phase 1UNKNOWN
Sponsor

Bio-innova Co., Ltd

Enrollment

32

Started

2024

Primary outcome

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)

Healthy Subjects

Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

NCT00319163Phase 1COMPLETED
Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Enrollment

26

Started

2006

Primary outcome

Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound

Healthy

A Trial to Assess the Pharmacokinetic Profile (e.g., Uptake, Distribution and Excretion of a Substance in the Body) of Nomegestrol Acetate (NOMAC), Estradiol (E2) and Estrone (E1) After Multiple and Single Dose Administration of the Combined Oral Contraception NOMAC-E2 (COMPLETED)(P05822)

NCT00711607Phase 1COMPLETED
Sponsor

Organon and Co

Enrollment

25

Started

2007

Primary outcome

Plasma concentrations of NOMAC and serum concentrations of E2 and E1 measured at several time points before, during and after multiple dose and after single dose administration to determine pharmacokinetics

Healthy

An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin

NCT07269327Phase 1COMPLETED
Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Enrollment

24

Started

2025

Primary outcome

Baseline-Adjusted Area Under the Serum Concentration- Time Curve from Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-tlast,adj) for both r-hFSH and r-hLH

Fertility

Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females

NCT00357604Phase 1COMPLETED
Sponsor

Bristol-Myers Squibb

Enrollment

22

Started

2006

Primary outcome

To determine the effect of co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol

HIV Infections

Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325

NCT02103569Phase 1COMPLETED
Sponsor

Bristol-Myers Squibb

Enrollment

20

Started

2014

Primary outcome

Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone

Hepatitis C

A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives

NCT07414784Phase 1ACTIVE_NOT_RECRUITING
Sponsor

AbbVie

Enrollment

20

Started

2026

Primary outcome

Number of Participants with Adverse Events (AEs)

Healthy Volunteer

A Study of Milvexian in Healthy Adult Females

NCT05706753Phase 1COMPLETED
Sponsor

Janssen Pharmaceutica N.V., Belgium

Enrollment

20

Started

2023

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidzolam

Healthy Female

A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects

NCT03662516Phase 1COMPLETED
Sponsor

Pfizer

Enrollment

17

Started

2018

Primary outcome

AUCinf for EE

Healthy Females

Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product

NCT04193852Phase 1COMPLETED
Sponsor

Laboratorios Andromaco S.A.

Enrollment

10

Started

2019

Primary outcome

Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) ]

Bioequivalence

2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors

NCT00030095Phase 1COMPLETED
Sponsor

National Cancer Institute (NCI)

Started

2001

Unspecified Adult Solid Tumor, Protocol Specific

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