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MLE4901 vs. Placebo for the Treatment of PCOS

Primary Purpose

Polycystic Ovary Syndrome (PCOS)

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MLE4901
Placebo
Sponsored by
Millendo Therapeutics US, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) focused on measuring Acne, Hirsutism, Menstrual Irregularity, Alopecia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hope Research Institute, LLC
  • NEA Baptist Clinic
  • Excell Research
  • Clinical Research Consulting, LLC
  • Avail Clinical Research, LLC
  • Health Care Family Rehab & Research Center
  • University of Florida (UF)
  • Palmetto Professional Research
  • Segal Institute for Clinical Research
  • Compass Research, LLC
  • Stedman Clinical Trials, LLC
  • Atlanta Women's Research Institute
  • Advanced Clinical Research
  • Womens Health Practice
  • GTC Enterprises LLC
  • Montana Health Research Institute, Inc.
  • Upstate Clinical Research Associates
  • PMG Research of Cary
  • Rapid Medical Research, Inc.
  • Aventiv Research, Inc.
  • University Hospitals Cleveland Medical Center
  • Clinical Research of Tiffin
  • Main Line Fertility and Reproductive Medicine
  • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
  • University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care
  • Magnolia OB/GYN Research Center
  • Texas Diabetes and Endocrinology, P.A. - South Austin
  • Wasatch Clinical Research
  • Highland Clinical Research
  • Charlottesville Medical Research Center, LLC
  • Tidewater Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

MLE4901

Arm Description

Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets

Plain, round, biconvex, white film-coated tablets administered twice per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Menstrual Periods
Number of menstrual periods from baseline to the end of the 28 week double blind treatment period

Full Information

First Posted
August 10, 2016
Last Updated
January 28, 2021
Sponsor
Millendo Therapeutics US, Inc.
Collaborators
Medpace, Inc., Covance
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1. Study Identification

Unique Protocol Identification Number
NCT02865915
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
The risk/benefit profile no longer indicated continued development.
Study Start Date
July 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millendo Therapeutics US, Inc.
Collaborators
Medpace, Inc., Covance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome (PCOS)
Keywords
Acne, Hirsutism, Menstrual Irregularity, Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets
Arm Title
MLE4901
Arm Type
Experimental
Arm Description
Plain, round, biconvex, white film-coated tablets administered twice per day
Intervention Type
Drug
Intervention Name(s)
MLE4901
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match active drug
Primary Outcome Measure Information:
Title
Menstrual Cycle Duration
Description
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
Time Frame
28 Week double blind treatment period
Secondary Outcome Measure Information:
Title
Number of Menstrual Periods
Description
Number of menstrual periods from baseline to the end of the 28 week double blind treatment period
Time Frame
28 Week double blind treatment period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Hope Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Research Consulting, LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Health Care Family Rehab & Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
University of Florida (UF)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Palmetto Professional Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Women's Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Advanced Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Womens Health Practice
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
GTC Enterprises LLC
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Montana Health Research Institute, Inc.
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Clinical Research of Tiffin
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Main Line Fertility and Reproductive Medicine
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Magnolia OB/GYN Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Texas Diabetes and Endocrinology, P.A. - South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Tidewater Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MLE4901 vs. Placebo for the Treatment of PCOS

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