Thank you for your interest.
Recruitment for this study has now closed.

This study is not affiliated with PCOS Challenge, Inc.
The announcement below is being provided for informational purposes only.

PCOS Research Study Seeking Women with Polycystic Ovary Syndrome in Florida, Ohio, Virginia and Illinois*

Study Title

A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)

Study Description

This research is being done to find out whether a new investigational medication called MLE4901 works to help treat PCOS. MLE4901 is an investigational medication. This means that MLE4901 is still being studied. It also means that the U.S. Food and Drug Administration (FDA) has not approved MLE4901 for the treatment of PCOS. The FDA allows MLE4901 to be used only in research.

This treatment could potentially help to control the symptoms of PCOS such as hirsutism (excessive hair that appears in a male pattern), acne, and alopecia (thinning of hair on the top of the head), as well as improve frequency of menses, ovulation, and quality of life.

Goals

The goal of this study is to evaluate doses of MLE4901 (an investigational treatment) compared to placebo for the treatment of PCOS. It is aimed at evaluating the improvement in the symptoms of PCOS.

Eligibility Criteria

Inclusion Criteria:

  1. At least one of the following during Screening:
    • Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (excessive hair that appears in a male pattern), acne, or androgenic alopecia (hair loss on the top of the head)
    • Biochemical hyperandrogenism refers to an elevated serum androgen level (i.e., elevated total, bioavailable or free testosterone levels)
    • Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian size
  2. Body mass index (BMI) 22 to 45 kg/m2, inclusive
  3. 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
  4. Must be willing to avoid the use of all hair growth procedures and products during study participation

Exclusions

Exclusion Criteria:

  1. Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
  2. Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
  3. Uncontrolled hypo- or hyperthyroidism
  4. Post-hysterectomy or endometrial ablation
  5. Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
  6. Medical history of type 1 or type 2 diabetes mellitus

Compensation

Varies by site.

*Disclaimer

This study is not affiliated with PCOS Challenge, Inc. PCOS Challenge, Inc. does not recommend or endorse any specific studies, tests, physicians, products, procedures, opinions, or other information from third parties that may be mentioned on the PCOS Challenge websites. Any such mention is for information purposes only. Any third party services, products and websites, including those offered by affiliates, sponsors and advertisers, which may be accessed through the PCOS Challenge websites are the sole responsibility of the third party who is offering the service, product or posting the website. PCOS Challenge, Inc. makes no warranty as to the accuracy of any information on third party websites and accepts no liability for any claims, errors, and omissions or for any damage or injury to persons or property arising out of the use or operation of any services, products, materials, instructions, methods, ideas or procedures provided by third parties. Any offers, pricing, and/or promotions offered through the PCOS Challenge websites, affiliates, or any third party are subject change without notice at the sole discretion of the party making the offer. Read Full Disclaimer.

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