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

NCT05819853 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Semaglutide Injectable Product (Wegovy and/or Ozempic)

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Melanie Cree-Green, MD,PhD · University of Colorado Anschutz/Children's Hospital Colorado

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2028-02-01
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819853 on ClinicalTrials.gov