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MLE4901 vs. Placebo for the Treatment of PCOS

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Millendo Therapeutics, Inc.
Sponsor:
Collaborators:
Medpace, Inc.
Covance
Information provided by (Responsible Party):
Millendo Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02865915
First received: August 10, 2016
Last updated: May 16, 2017
Last verified: April 2017
  Purpose
This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.

Condition Intervention Phase
Polycystic Ovary Syndrome (PCOS)
Drug: MLE4901 40mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Millendo Therapeutics, Inc.:

Primary Outcome Measures:
  • Menstrual Cycle Duration [ Time Frame: 28 Week double blind treatment period ]
    Assessment of the number of days between menstrual cycles from baseline to end of 28 week double blind treatment period


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 130
Actual Study Start Date: July 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 40mg
Plain, round, biconvex, white film-coated tablets of 40 mg strength administered twice per day
Drug: MLE4901 40mg

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02865915

Contacts
Contact: Cathy M Radovich, BS 734.545.8151 radovich@millendo.com
Contact: Marianne Plaunt, PhD 734.249.6030 plaunt@millendo.com

  Show 31 Study Locations
Sponsors and Collaborators
Millendo Therapeutics, Inc.
Medpace, Inc.
Covance
Investigators
Study Director: Vivian Lin, MD Millendo Therapeutics, Inc.
  More Information

Responsible Party: Millendo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02865915     History of Changes
Other Study ID Numbers: MLE4901-101
2016-002179-91 ( EudraCT Number )
Study First Received: August 10, 2016
Last Updated: May 16, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Millendo Therapeutics, Inc.:
Acne
Hirsutism
Menstrual Irregularity
Alopecia

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017