MLE4901 vs. Placebo for the Treatment of PCOS

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Polycystic Ovary Syndrome (PCOS)

In brief

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

Key facts

Study ID

NCT02865915

Run by

Millendo Therapeutics US, Inc.

People needed

55

Starts

2016-07-01

Expected to finish

2017-09-01

Last updated by the study team

2021-02-01

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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