Clinical trial NCT02865915: MLE4901 vs. Placebo for the Treatment of PCOS
Official title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: Acne
Hirsutism
Menstrual Irregularity
Alopecia
Lead sponsor: Millendo Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
name: Covance
First posted: 2016-08-15
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Menstrual Cycle Duration
timeFrame: 28 Week double blind treatment period
Secondary outcomes:
measure: Number of Menstrual Periods
timeFrame: 28 Week double blind treatment period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute, LLC
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab & Research Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida (UF)
state: Florida
city: Miami
country: United States
facility: Palmetto Professional Research
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Champaign
country: United States
facility: Womens Health Practice
state: Illinois
city: Shawnee Mission
country: United States
facility: GTC Enterprises LLC
state: Kansas
city: Billings
country: United States
facility: Montana Health Research Institute, Inc.
state: Montana
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Cary
country: United States
facility: PMG Research of Cary
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Mayfield Heights
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Tiffin
country: United States
facility: Clinical Research of Tiffin
state: Ohio
city: Bryn Mawr
country: United States
facility: Main Line Fertility and Reproductive Medicine
state: Pennsylvania
city: Hershey
country: United States
facility: The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Magnolia OB/GYN Research Center
state: South Carolina
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology, P.A. - South Austin
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Norfolk
country: United States
facility: Tidewater Clinical Research, Inc.
state: Virginia
Study officials:
References: