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E.N.D.E.A.V.O.R. Study: Exemestane for PCOS/PMOS Ovulation Induction

This study, called E.N.D.E.A.V.O.R., is looking into whether exemestane, a medication, can help women with polycystic ovary syndrome (PCOS) or polyendocrine metabolic ovarian syndrome (PMOS) ovulate. Researchers want to see if exemestane increases the chances of ovulation and to understand any side effects it might have in this group of patients. You might be eligible to join if you are a premenopausal woman between 18 and 40 years old, have been evaluated for infertility at UNC Fertility, and have a diagnosis of PCOS/PMOS. The main goal is to see how many participants have positive progesterone levels on Day 21 of their menstrual cycle after taking the study medication. The current status of the study is unclear.

Study design
This interventional study plans to enroll 40 participants. It compares two doses of exemestane (25 MG and 50 MG) against a placebo (a look-alike substance with no drug).
What's involved
Participants will take exemestane or a placebo daily for 5-10 days. You will visit the clinic three times for ultrasounds, lab tests, and to discuss any side effects.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at day 21 of the menstrual cycle that the patient receives the study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07706374

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

Recruiting
PHASE1Ages 18–40InterventionalTreatment
University of North Carolina, Chapel Hill
~40 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Exemestane 25 MGPlaceboExemestane 50 MG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with study-defined positive progesterone levels on Day 21
Measured over day 21 of menstrual cycle that patient receives study intervention

Conditions

Poly Cystic Ovary Syndrome

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NCT07706374

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UNC Fertility

    Raleigh, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bruce Pier, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Bruce D Pier, MD
[email protected]
919-908-0000
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

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

    The primary outcome of this study will be positive day 21 progesterone levels (positive level \>/= 3 ng/mL).