MLE4901 vs. Placebo for the Treatment of PCOS

NCT ID: NCT02865915

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-09-30

Brief 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

Conditions

Polycystic Ovary Syndrome (PCOS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match active drug

MLE4901

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

Group Type: EXPERIMENTAL

MLE4901

Intervention Type: DRUG

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.

Interventions

MLE4901

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.

Intervention Type: DRUG

Placebo

Placebo to match active drug

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Covance

INDUSTRY

Sponsor Role: collaborator

Millendo Therapeutics US, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Stedman Clinical Trials, LLC

Tampa, Florida, United States

Atlanta Women's Research Institute

Atlanta, Georgia, United States

Advanced Clinical Research

Boise, Idaho, United States

Womens Health Practice

Champaign, Illinois, United States

GTC Enterprises LLC

Shawnee Mission, Kansas, United States

Montana Health Research Institute, Inc.

Billings, Montana, United States

Upstate Clinical Research Associates

Williamsville, New York, United States

PMG Research of Cary

Cary, North Carolina, United States

Rapid Medical Research, Inc.

Cleveland, Ohio, United States

Aventiv Research, Inc.

Columbus, Ohio, United States

University Hospitals Cleveland Medical Center

Mayfield Heights, Ohio, United States

Clinical Research of Tiffin

Tiffin, Ohio, United States

Main Line Fertility and Reproductive Medicine

Bryn Mawr, Pennsylvania, United States

The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care

Philadelphia, Pennsylvania, United States

Magnolia OB/GYN Research Center

Myrtle Beach, South Carolina, United States

Texas Diabetes and Endocrinology, P.A. - South Austin

Austin, Texas, United States

Wasatch Clinical Research

Salt Lake City, Utah, United States

Highland Clinical Research

Salt Lake City, Utah, United States

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, United States

Tidewater Clinical Research, Inc.

Norfolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-002179-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MLE4901-101

Identifier Type: -

Identifier Source: org_study_id