See if exemestane helps PMOS patients ovulate compared with placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial compares exemestane at two dose levels to placebo in premenopausal women with PCOS/PMOS who have not tried ovulation induction before. Participants take the study medication daily for 5–10 days and undergo three clinic visits for ultrasounds and lab assessments to monitor ovulation and side effects. The study also collects information on pregnancy outcomes if pregnancy occurs. The goal is to determine if exemestane can induce ovulation and to characterize its safety profile in this population.

Why it matters

Who can join: the full rules

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)

Where it's running

• UNC Fertility
  Raleigh, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Bruce Pier, MD — University of North Carolina, Chapel Hill

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Alpha-lipoic acid and myo-inositol for non-diabetic PCOS in women

  This trial tests whether adding alpha-lipoic acid to myo-inositol (with or without metformin) helps non-diabetic women with PCOS improve menstrual regularity and ovulation.

  Recruiting Phase 3 Beni-Suef University · Cairo, Cairo Governorate · NCT07630779

• Comparing Vildagliptin and Metformin for treating Polycystic Ovary Syndrome

  This study is testing whether Vildagliptin or Metformin works better to help women with Polycystic Ovary Syndrome manage their symptoms.

  Recruiting Phase 2/3 October 6 University · Giza · NCT06142656

• Light color therapy to help chronic pain

  This small crossover study tests whether colored light (S-cone chromatic light) can reduce pain in adults with fibromyalgia or chronic widespread pain compared with white light over two 7-day periods.

  Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT07825792

• Personalized PandA-tACS for Antenatal Depression

  This study tests whether a single personalized brain stimulation session can help pregnant people with depression more than a standard or sham stimulation.

  Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT07799480

• Melanin-Adjusted Blood Oxygen Sensor in ICU Patients

  This study tests a new pulse oximeter that adjusts for skin pigment to see if it gives accurate oxygen readings in ICU patients.

  Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT07799454

• Daily Upgrade: Can an essential amino acid supplement help active women improve body composition and metabolism?

  This study tests whether Daily Upgrade EAA+ helps healthy, active women by comparing it with whey protein and placebo before HIIT, and by using it daily for three weeks with twice-weekly HIIT workouts.

  Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT07792603

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.