Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome (NCT05819853) | Clinical Trial Compass
RecruitingPhase 3
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
United States80 participantsStarted 2023-11-03
Plain-language 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.
Who can participate
Age range12 Years – 35 Years
SexFEMALE
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Inclusion criteria
✓. Female
✓. Ages 12-35 years
✓. Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.
✓. Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines
✓. Initial BMI based on age and weight:
✓. If \<18 years, initial BMI percentile ≥95
✓. 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
✓. Must be weight stable within ±5kg in the 3 months prior to enrollment
Exclusion criteria
✕. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening. - Per approved drug label
✕. Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of the study), chronic oral steroids, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, estrogen-containing hormonal contraception (cannot have been used in the 6 months prior to screening), progesterone-containing hormonal contraception (cannot have been used in the 3 months prior to screening). Dermal patch or vaginal ring contraception methods. Weight loss medications or stimulants. Use of other products containing other GLP-1 agonists.
What they're measuring
1
Change in ovulation frequency before and after semaglutide in females with PCOS