Recruiting
Phase 1

Exemestane

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07706374

Conditions

Poly Cystic Ovary Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Exemestane 25 MG

Placebo

Exemestane 50 MG

Study Details

Brief 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.

Conditions

Poly Cystic Ovary Syndrome

Study ID

NCT07706374

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PMOS (PCOS) patients taking 25mg for 5 days

Participants in this arm will take one tablet of study drug for 5 days

experimental: 50mg Exemestane for 5 days

Participants in this arm will take two tablets of study drug for 5 days

experimental: 25mg Exemestane for 10 days

Participants in this arm will take one tablet of study drug for 10 days

placebo comparator: Placebo

Participants in this arm will take placebo for 5 days

Interventions

Exemestane 25 MG

Experimental Drug

Placebo

Placebo drug that patients in placebo arm will take

Exemestane 50 MG

One study arm with take two tablets for 5 days (50mg per day)

Primary outcome measure

  • Number of participants with study-defined positive progesterone levels on Day 21 [ Time Frame: day 21 of menstrual cycle that patient receives study intervention ]

Central Contacts and Locations

Locations

UNC Fertility

Recruiting

Raleigh, North Carolina, United States, 27617

Contacts

Bruce D Pier, MD

919-908-0000bruce_pier@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • ovulation
  • androgen
  • aromatase

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-08-14.