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