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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 12
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

• 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

• 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 receive semaglutide, they should avoid pregnancy for at least 2 months after stopping medication to avoid fetal exposure to the medication.

• For participants in the metformin + semaglutide group, participants must have been stable on ≥ 1500 mg of metformin a day for at least 3 months by time of screening

Locations
United States
Colorado
University of Colorado Anschutz/Children's Hospital Colorado Aurora
RECRUITING
Aurora
Contact Information
Primary
Yesenia Garcia-Reyes, MS
PCOSresearch@cuanschutz.edu
720-777-6984
Time Frame
Start Date: 2023-11-03
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 80
Treatments
Experimental: Untreated PCOS
Participants with PCOS who are not on metformin or hormonal therapy, will receive 10-months of semaglutide intervention.~Participants will get either semaglutide as either:~Wegovy: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and 1.7mg for the remainder of the study.~or~Ozempic: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and Wegovy for 1.7mg for the remainder of the study.
Experimental: PCOS on Metformin
Participants with PCOS who are currently on metformin and still not having regular menses, will receive 10-months of semaglutide intervention. Participants in this arm will continue to take their metformin throughout the trial.~Participants will get either semaglutide as either:~Wegovy: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and 1.7mg for the remainder of the study.~or~Ozempic: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and Wegovy for 1.7mg for the remainder of the study.
Sponsors
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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