MLE4901 vs. Placebo for the Treatment of PCOS

• Status: Terminated
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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