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Could a breast cancer drug help women with PCOS ovulate?

NCT ID NCT07706374

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 40 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • UNC Fertility

    RECRUITING

    Raleigh, North Carolina, 27617, United States

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