MLE4901 vs. Placebo for the Treatment of PCOS

Polycystic Ovary Syndrome (PCOS) Clinical Trial

Official title:

A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02865915
• Other study ID #: MLE4901-101
• Secondary ID: 2016-002179-91
• Status: Terminated
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2021
• Source: Millendo Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS)
• Syndrome

Intervention

Drug:
• 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.
• Placebo
Placebo to match active drug

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Millendo Therapeutics US, Inc.	Covance, Medpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Menstrual Periods	Number of menstrual periods from baseline to the end of the 28 week double blind treatment period	28 Week double blind treatment period