E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction R… (NCT07706374) | Clinical Trial Compass
Not Yet RecruitingPhase 1
E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
United States40 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with study-defined positive progesterone levels on Day 21
Timeframe: day 21 of menstrual cycle that patient receives study intervention