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NOT YET RECRUITING
NCT07706374
PHASE1

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

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-08

Completion Date

2030-01

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

DRUG

Exemestane 25 MG

Experimental Drug

DRUG

Placebo

Placebo drug that patients in placebo arm will take

DRUG

Exemestane 50 MG

One study arm with take two tablets for 5 days (50mg per day)

Locations (1)

UNC Fertility

Raleigh, North Carolina, United States