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Trial record 1 of 1 for:    MLE4901
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MLE4901 vs. Placebo for the Treatment of PCOS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02865915
Recruitment Status : Terminated (The risk/benefit profile no longer indicated continued development.)
First Posted : August 15, 2016
Results First Posted : June 16, 2020
Last Update Posted : February 1, 2021
Medpace, Inc.
Information provided by (Responsible Party):
Millendo Therapeutics, Inc. ( Millendo Therapeutics US, Inc. )

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

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome (PCOS) Drug: MLE4901 Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
Actual Study Start Date : July 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Menstrual Cycle Duration [ Time Frame: 28 Week double blind treatment period ]
    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 :
  1. Number of Menstrual Periods [ Time Frame: 28 Week double blind treatment period ]
    Number of menstrual periods from baseline to the end of the 28 week double blind treatment period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02865915

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Sponsors and Collaborators
Millendo Therapeutics US, Inc.
Medpace, Inc.
  Study Documents (Full-Text)

Documents provided by Millendo Therapeutics, Inc. ( Millendo Therapeutics US, Inc. ):
Study Protocol  [PDF] March 8, 2017
Statistical Analysis Plan  [PDF] June 29, 2017

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Responsible Party: Millendo Therapeutics US, Inc. Identifier: NCT02865915    
Other Study ID Numbers: MLE4901-101
2016-002179-91 ( EudraCT Number )
First Posted: August 15, 2016    Key Record Dates
Results First Posted: June 16, 2020
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Millendo Therapeutics, Inc. ( Millendo Therapeutics US, Inc. ):
Menstrual Irregularity
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases