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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05819853
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 53

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome is one of the most common endocrinopathies in women, presents with anovulation in adolescence, and reproductive dysfunction is related to excess weight. After a 4-month observation period of either no medication or metformin treatment, females aged 12-35 years with obesity and polycystic ovary syndrome will receive 10 months of a glucagon-like peptide-1 receptor agonist to induce metabolic changes, weight loss and improve reproductive abnormalities. We will assess the relationship between weight loss and reproductive function, as well as identify if age, hormonal and metabolic measures and such insulin sensitivity and insulin secretion predict the response to glucagon-like peptide-1 receptor agonist therapy.

Condition or Disease	Intervention/Treatment	Phase
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Obese	Drug: Semaglutide	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2028
• Anticipated Study Completion Date: Feb 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metformin + Semaglutide	Drug: Semaglutide; 10 months of semaglutide, with dose escalation as recommended by manufacturer
Active Comparator: Semaglutide	Drug: Semaglutide; 10 months of semaglutide, with dose escalation as recommended by manufacturer

Outcome Measures

Primary Outcome Measures

1. Rate of ovulation [60 months]

   Number of ovulations as assessed by urinary progesterone in 3 month before and during treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria: PCOS -

Exclusion Criteria: Type 1 or Type 2 Diabetes

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT05819853
• Other Study ID Numbers: 21-4941
• First Posted: Apr 19, 2023
• Last Update Posted: Apr 19, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of Colorado, Denver: PCOS; semaglutide
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome

Study Results

No Results Posted as of Apr 19, 2023