RecruitingPhase 3NCT05819853

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


Sponsor

University of Colorado, Denver

Enrollment

80 participants

Start Date

Nov 3, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 12 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether semaglutide — a medication used for weight loss and type 2 diabetes — can help restore regular menstrual cycles and ovulation in young women and girls with polycystic ovary syndrome (PCOS) who are overweight or obese and currently not ovulating regularly. PCOS is a hormonal condition that can affect periods, fertility, and metabolism. **You may be eligible if...** - You are female, aged 12–35 - You are sedentary (less than 2 hours of moderate exercise per week) - You have PCOS with irregular periods (oligomenorrhea) - If under 18: your BMI is at or above the 95th percentile for your age - If 18–35: your BMI is 30 or higher, OR 27 or higher with a weight-related health problem like high blood pressure **You may NOT be eligible if...** - You have previously used semaglutide or similar GLP-1 medications - You have a history of pancreatitis or thyroid cancer - You are pregnant or breastfeeding - You have serious kidney or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide Injectable Product (Wegovy and/or Ozempic)

10 months of semaglutide, with dose escalation as recommended by manufacturer. Maximum dose used will be 1.7mg


Locations(1)

University of Colorado Anschutz/Children's Hospital Colorado Aurora

Aurora, Colorado, United States

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NCT05819853


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