RECRUITING Phase 1 ClinicalTrials.gov

E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study

Sponsor: University of North Carolina, Chapel Hill • ClinicalTrials.gov ID: NCT07706374

Registry updated: 2026-09-23

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Description

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.

Interventions

Exemestane 25 MG (Drug)
Experimental Drug
Placebo (Drug)
Placebo drug that patients in placebo arm will take
Exemestane 50 MG (Drug)
One study arm with take two tablets for 5 days (50mg per day)

Eligibility criteria

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 must have a normal semen analysis if presenting with a male partner; * Individuals must be ovulation induction naïve (no history of use of ovulation induction medications); * Individuals must be able to read, speak, and understand English or Spanish sufficiently to provide informed consent and participate in study procedures. Exclusion Criteria: Any individual who meets one or more of the following criteria will be excluded from participation: * Under 18 or over 40 years of age; Individuals without the diagnosis of PCOS; * Body mass index \>40 kg/m\^2; Abnormal hysterosalpingogram; * Abnormal semen analysis if presenting with a male partner; * History of ovulation induction medication use; * Allergy to exemestane; * Individuals with abnormalities of Pap smear or breast examination; * Pregnant females; * Individuals with moderate to severe renal impairment; * Individuals with moderate to severe hepatic impairment; * Currently taking any of the following medications due to known or potential interactions with exemestane: Cytochrome P-450 3A4 (CYP3A4), Everolimus (Afinitor), Apixaban (Eliquis), Rivaroxaban (Xarelto), Aspirin, Diphenhydramine (Benadryl), Rosuvastatin (Crestor), Duloxetine (Cymbalta), Escitalopram (Lexapro), Atorvastatin (Lipitor), Pregabalin (Lyrica), Metoprolol, Semaglutide (Ozempic), Levothyroxine (Synthroid), Ondansetron (Zofran), Goserelin (Zoladex); * Individuals who require a Legally Authorized Representative (LAR) to provide consent on their behalf; * Difficulty or inability to swallow solid dosage forms (tablets/capsules of study drug)

Conditions

Poly Cystic Ovary Syndrome

Locations

UNC Fertility — Raleigh, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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