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Could a breast cancer drug help women with PCOS ovulate?
NCT ID NCT07706374
First seen Jul 15, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tests whether exemestane, a drug typically used for breast cancer, can help women with polycystic ovary syndrome (PCOS) ovulate. Participants take either a low or high dose of exemestane or a placebo for 5 to 10 days. Researchers track ovulation through blood tests and ultrasounds, and monitor side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- exemestane, an aromatase inhibitor drug
- What this could lead to
- If successful, exemestane could offer a new, short-course option to induce ovulation in women with PCOS who have trouble conceiving.
- What could go wrong
- This is an early-phase trial with only 40 participants, so results may not apply broadly. Side effects and lack of ovulation are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UNC Fertility
RECRUITINGRaleigh, North Carolina, 27617, United States
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