MLE4901 vs. Placebo for the Treatment of PCOS

Phase 2

Terminated

• Conditions: Polycystic Ovary Syndrome (PCOS)
• Interventions: Drug: Placebo; Drug: MLE4901

• Registration Number: NCT02865915
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Results First Submitted: 2020-06-01
• Results First Submitted QC: 2020-06-01
• Results First Posted: 2020-06-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets
MLE4901	MLE4901	Plain, round, biconvex, white film-coated tablets administered twice per day

Primary Outcome Measures

Name	Time	Method
Menstrual Cycle Duration	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

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

Trial Locations

Locations (31)

Hope Research Institute, LLC; 🇺🇸 Phoenix, Arizona, United States

NEA Baptist Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Excell Research; 🇺🇸 Oceanside, California, United States

Clinical Research Consulting, LLC; 🇺🇸 Milford, Connecticut, United States

Avail Clinical Research, LLC; 🇺🇸 DeLand, Florida, United States

Health Care Family Rehab & Research Center; 🇺🇸 Hialeah, Florida, United States

University of Florida (UF); 🇺🇸 Jacksonville, Florida, United States

Palmetto Professional Research; 🇺🇸 Miami, Florida, United States

Segal Institute for Clinical Research; 🇺🇸 North Miami, Florida, United States

Compass Research, LLC; 🇺🇸 Orlando, Florida, United States

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