Study Stopped
The risk/benefit profile no longer indicated continued development.
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)
2 other identifiers
interventional
55
1 country
31
Brief Summary
This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2016
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
June 16, 2020
CompletedFebruary 1, 2021
January 1, 2021
1.2 years
August 10, 2016
June 1, 2020
January 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Menstrual Cycle Duration
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
28 Week double blind treatment period
Secondary Outcomes (1)
Number of Menstrual Periods
28 Week double blind treatment period
Study Arms (2)
Placebo
PLACEBO COMPARATORPlain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets
MLE4901
EXPERIMENTALPlain, round, biconvex, white film-coated tablets administered twice per day
Interventions
Eligibility Criteria
You may qualify if:
- Oligo-/amenorrhea
- 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
- Body mass index (BMI) 22 to 45 kg/m2, inclusive
- Must be willing to avoid use of all hair removal procedures and products during study participation
- 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
- Must be willing to avoid the use of all hair growth procedures and products during study participation
- 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.
You may not qualify if:
- Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) \>10 IU/L
- Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
- Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
- Uncontrolled hypo- or hyperthyroidism
- Post-hysterectomy or endometrial ablation
- Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
- Medical history of type 1 or type 2 diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Millendo Therapeutics US, Inc.lead
- Medpace, Inc.collaborator
- Covancecollaborator
Study Sites (31)
Hope Research Institute, LLC
Phoenix, Arizona, 85018, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Excell Research
Oceanside, California, 92056, United States
Clinical Research Consulting, LLC
Milford, Connecticut, 06460, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Health Care Family Rehab & Research Center
Hialeah, Florida, 33012, United States
University of Florida (UF)
Jacksonville, Florida, 32207, United States
Palmetto Professional Research
Miami, Florida, 33175, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Atlanta Women's Research Institute
Atlanta, Georgia, 30342, United States
Advanced Clinical Research
Boise, Idaho, 83642, United States
Womens Health Practice
Champaign, Illinois, 61820, United States
GTC Enterprises LLC
Shawnee Mission, Kansas, 66218, United States
Montana Health Research Institute, Inc.
Billings, Montana, 59102, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
PMG Research of Cary
Cary, North Carolina, 27518, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Aventiv Research, Inc.
Columbus, Ohio, 43213, United States
University Hospitals Cleveland Medical Center
Mayfield Heights, Ohio, 44124, United States
Clinical Research of Tiffin
Tiffin, Ohio, 44883, United States
Main Line Fertility and Reproductive Medicine
Bryn Mawr, Pennsylvania, 19010, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care
Philadelphia, Pennsylvania, 19104, United States
Magnolia OB/GYN Research Center
Myrtle Beach, South Carolina, 29572, United States
Texas Diabetes and Endocrinology, P.A. - South Austin
Austin, Texas, 78749, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Tidewater Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Millendo Therapeutics US, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 15, 2016
Study Start
July 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
February 1, 2021
Results First Posted
June 16, 2020
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share