MLE4901 vs. Placebo for the Treatment of PCOS

Millendo Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Polycystic Ovary Syndrome (PCOS)

Treatments: Drug: MLE4901; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02865915

MLE4901-101

2016-002179-91 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 55 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

55 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

MLE4901

Experimental group

Description:

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

Treatment:

Drug: MLE4901