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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05819853
Phase
PHASE3
Status
Recruiting
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Conditions

  • Obese
  • PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 3, 2023
Status verified
Aug 2025
Primary completion
Feb 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in ovulation frequency before and after semaglutide in females with PCOS [ Time Frame: 14 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz/Children's Hospital Colorado AuroraAuroraColorado80045
Yesenia Garcia Reyes
[email protected]
720-777-6984

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By research site
University of Colorado Anschutz/Children's Hospital Colorado Aurora· Aurora, CO

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