Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Syndrome

Polycystic Ovary Syndrome

Acne Vulgaris

Alopecia

Alopecia Areata

Hirsutism

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets

Plain, round, biconvex, white film-coated tablets administered twice per day

For 80% of subjects randomized to MLE4901 (n=24/30), the dose is 40 mg twice daily. Six subjects (20%) randomized to higher MLE4901 dose cohorts that were promptly discontinued.

MLE4901

Placebo

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

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

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)

Assessment of the number of days between menstrual cycles (i.e., days between the start of a menstrual period and the start of the next consecutive menstrual period) from baseline to end of 28 week double blind treatment period

Number of menstrual periods from baseline to the end of the 28 week double blind treatment period

Medpace, Inc.

Covance

Millendo Therapeutics US, Inc.

Treatment with 1 matching placebo tablet self-administered twice daily

Placebo Treatment Arm

Treatment with 1 tablet of MLE4901 self-administered twice daily \[80% treated with dose of 40 mg twice daily\]

MLE4901 Treatment Arm

Matching placebo tablet self-administered twice daily

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Menstrual cycle frequency

Due to termination of the study by the Sponsor, no patients completed the study. No efficacy data are available because study termination occurred prior to scheduled assessments.

Director of Clinical Operations

Treatment with 1 tablet of study drug self-administered twice daily (most dosed with 40 mg BID)

Spots Global Cancer Trial Database for mle4901

Every month we try and update this database with for mle4901 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mle4901

Every month we try and update this database with for mle4901 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mle4901 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.