Loading clinical trials...

MLE4901 vs. Placebo for the Treatment of PCOS | Clinical Trials | Clareo Health

TERMINATEDPHASE2

MLE4901 vs. Placebo for the Treatment of PCOS

A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)

NCT02865915•Millendo Therapeutics US, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.

Detailed Description

Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge) will be used to better characterize the study population. A Treatment Period of 28 weeks' duration will follow the Lead-in Period. Then, an 8-week Follow-up Period (i.e., no study drug) will be used to assess the durability of effects of MLE4901. The study duration will be approximately 48 weeks (11 months) per subject

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Oligo-/amenorrhea
•2. At least one of the following during Screening:
•* Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (defined as excessive terminal hair that appears in a male pattern), acne, or androgenic alopecia
•* Biochemical hyperandrogenism refers to an elevated serum androgen level (i.e., total, bioavailable or free testosterone level ≥ULN)
•* Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian volume \>10 mL (without a cyst or dominant follicle) in either ovary
•3. Body mass index (BMI) 22 to 45 kg/m2, inclusive
•4. Must be willing to avoid use of all hair removal procedures and products during study participation
•5. Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
•6. Must be willing to avoid the use of all hair growth procedures and products during study participation
•7. Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) \>2 years or male partner(s) has had a vasectomy \>2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide, diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.

Exclusion Criteria

•1. Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) \>10 IU/L
•2. Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
•3. Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
•4. Uncontrolled hypo- or hyperthyroidism
•5. Post-hysterectomy or endometrial ablation
•6. Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
•7. Medical history of type 1 or type 2 diabetes mellitus

Locations (31)

Hope Research Institute, LLC

Phoenix, Arizona, United States

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Excell Research

Oceanside, California, United States

Clinical Research Consulting, LLC

Milford, Connecticut, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Health Care Family Rehab & Research Center

Hialeah, Florida, United States

University of Florida (UF)

Jacksonville, Florida, United States

Palmetto Professional Research

Miami, Florida, United States

Segal Institute for Clinical Research

North Miami, Florida, United States

Compass Research, LLC

Orlando, Florida, United States

Key Dates

Start Date

July 1, 2016

Primary Completion Date

September 1, 2017

Completion Date

September 1, 2017

Last Updated

February 1, 2021

Enrollment

ACTUAL participants

Conditions

Polycystic Ovary Syndrome (PCOS)

Interventions

MLE4901

DRUG

Placebo

DRUG

Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants

NCT07129434

Polycystic Ovary Syndrome (PCOS)Obesity &Amp;Amp; Overweight

View study

RECRUITINGPHASE2

Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome

NCT06842524

Polycystic Ovary Syndrome (PCOS)

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MLE4901 vs. Placebo for the Treatment of PCOS

Inclusion Criteria

Exclusion Criteria

Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants

Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome

Semaglutide in Women With Polycystic Ovary Syndrome and Obesity

SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)

Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition

Amelioration of Polycystic Ovary Syndrome Related Disorders by Supplementation of Thymoquinone and Metformin