MLE4901 vs. Placebo for the Treatment of PCOS
Condition: Polycystic Ovary Syndrome (PCOS)
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: MLE4901; Placebo
Intervention description: For 80% of subjects randomized to MLE4901 (n=24/30), the dose is 40 mg twice daily. Six subjects (20%) randomized to higher MLE4901 dose cohorts that were promptly discontinued.; Placebo to match active drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acne; Hirsutism; Menstrual Irregularity; Alopecia

Summary:

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

Eligibility 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