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

Conditions

• Poly Cystic Ovary Syndrome

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• Exemestane 25 MG — DRUG
  Experimental Drug
• Placebo — DRUG
  Placebo drug that patients in placebo arm will take
• Exemestane 50 MG — DRUG
  One study arm with take two tablets for 5 days (50mg per day)

Study Details

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 Dates

First listed

Jul 15, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Dec 31, 2028

Completion

Jan 31, 2030

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: PMOS (PCOS) patients taking 25mg for 5 days
  Participants in this arm will take one tablet of study drug for 5 days
• Experimental: 50mg Exemestane for 5 days
  Participants in this arm will take two tablets of study drug for 5 days
• Experimental: 25mg Exemestane for 10 days
  Participants in this arm will take one tablet of study drug for 10 days
• Placebo Comparator: Placebo
  Participants in this arm will take placebo for 5 days

Primary Outcome Measure

Number of participants with study-defined positive progesterone levels on Day 21 [ Time Frame: day 21 of menstrual cycle that patient receives study intervention ]

Locations (1)

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