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Recruiting Phase 3 NCT05819853

Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome

Trial Parameters

Condition PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Sponsor University of Colorado, Denver
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 80
Sex FEMALE
Min Age 12 Years
Max Age 35 Years
Start Date 2023-11-03
Completion 2028-02-01
Interventions
Semaglutide Injectable Product (Wegovy and/or Ozempic)

Brief Summary

Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.

Eligibility Criteria

Inclusion Criteria 1. Female 2. Ages 12-35 years 3. Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week. 4. Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines 5. Initial BMI based on age and weight: 1. If \<18 years, initial BMI percentile ≥95 2. If 18-35 years, initial BMI ≥30 kg/m2 OR initial BMI ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia 3. Must be weight stable within ±5kg in the 3 months prior to enrollment 6. Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea \>24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia 7. Participants cannot be on hormonal contraception, so participants should remain abstinent or use reliable non-hormonal contraception (e.g., copper IUD) for the entire study period. For participants who recei

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