E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
University of North Carolina, Chapel Hill
Summary
The goal of this clinical trial is to learn if study drug exemestane will increase chances of ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS, formerly called polycystic ovary syndrome (PCOS)). It will also learn about side effects of study drug exemestane in this study population. The main questions it aims to answer are: Does exemestane lead to ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS- formerly called PCOS)? Researchers will compare exemestane to a placebo (a look-alike substance that contains no drug) to see if exemestane helps PMOS patients ovulate. Participants will: Take exemestane or a placebo every day for 5-10 days Visit the clinic three times for ultrasounds, labs, and to answer questions about side effects. If they become pregnant during this study, they will tell us how their pregnancy went after the study via a registry online.
Description
Polycystic ovarian syndrome (PCOS/PMOS) is the leading cause of anovulation and infertility in reproductive age females in the United States with an overall incidence of 7-12% (1-2). The prevalence of subfertility ranges from 20-40% in women diagnosed with PCOS/PMOS (3). While the exact pathogenesis of PCOS/PMOS remains unknown, the symptoms of PCOS/PMOS are thought to be caused by abnormal elevated levels of androgens, which in turn interfere with the normal function of the ovaries (4). PCOS/PMOS is diagnosis of exclusion using the Rotterdam Criteria, which requires the presence of two out of…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Premenopausal female (ages 18-40); * Undergone an evaluation for infertility at UNC Fertility; * Previously diagnosed with polycystic ovary syndrome/ polyendocrine metabolic ovarian syndrome (PCOS/PMOS) via established clinical diagnostic criteria with no other identifiable cause of infertility (example- endometriosis, uterine fibroids), and recommended to begin ovulation induction therapy; * Have patent fallopian tubes on hysterosalpingogram; * Male partners mus…
Interventions
- DrugExemestane 25 MG
Experimental Drug
- DrugPlacebo
Placebo drug that patients in placebo arm will take
- DrugExemestane 50 MG
One study arm with take two tablets for 5 days (50mg per day)
Location
- UNC FertilityRaleigh, North Carolina