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)

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

Study Overview

• Status: Terminated
• Conditions: Polycystic Ovary Syndrome (PCOS)
• Intervention / Treatment: Drug: Placebo; Drug: MLE4901

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

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • HOPE Research Institute, LLC
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
  • California
    • Oceanside, California, United States, 92056
      • Excell Research
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting, LLC
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Hialeah, Florida, United States, 33012
      • Health Care Family Rehab & Research Center
    • Jacksonville, Florida, United States, 32207
      • University of Florida (UF)
    • Miami, Florida, United States, 33175
      • Palmetto Professional Research
    • North Miami, Florida, United States, 33161
      • Segal Institute for Clinical Research
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Women's Research Institute
  • Idaho
    • Boise, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Womens Health Practice
  • Kansas
    • Shawnee Mission, Kansas, United States, 66218
      • GTC Enterprises LLC
  • Montana
    • Billings, Montana, United States, 59102
      • Montana Health Research Institute, Inc.
  • New York
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Cary
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
    • Columbus, Ohio, United States, 43213
      • Aventiv Research, Inc.
    • Mayfield Heights, Ohio, United States, 44124
      • University Hospitals Cleveland Medical Center
    • Tiffin, Ohio, United States, 44883
      • Clinical Research of Tiffin
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Main Line Fertility and Reproductive Medicine
    • Hershey, Pennsylvania, United States, 17033
      • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Magnolia Ob/Gyn Research Center
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes and Endocrinology, P.A. - South Austin
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets	Drug: Placebo; Placebo to match active drug
Experimental: MLE4901; Plain, round, biconvex, white film-coated tablets administered twice per day	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Millendo Therapeutics US, Inc.
• Collaborators: Covance; Medpace, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Acne; Alopecia; Hirsutism; Menstrual Irregularity
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: MLE4901-101; 2016-002179-91 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No