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NCT05819853 · ClinicalTrials.gov registry record · Phase 3
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
A Phase 3 study of Obese and PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05819853 is a Phase 3 study of Obese and PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 80 participants, below the 209-participant average among 27 other Obese trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05819853, a Phase 3 study of Obese and PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Semaglutide Injectable Product (Wegovy and/or Ozempic)
Study Locations (1)
Colorado
- University of Colorado Anschutz/Children's Hospital Colorado Aurora - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-11-03 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05819853
The ClinicalTrials.gov registry entry for NCT05819853 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 27 other Obese trials with a reported enrollment target (62% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obese appearing as the primary indexed condition, and to 1 intervention - of which Semaglutide Injectable Product (Wegovy and/or Ozempic) is the first listed.
NCT05819853 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT05819853 about?
NCT05819853 is a clinical study titled "Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome". 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.
What is the current status of trial NCT05819853?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2023-11-03. Estimated completion is 2028-06-30.
What conditions does trial NCT05819853 study?
This clinical trial studies the following conditions: Obese, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries.
What interventions are being tested in trial NCT05819853?
The interventions under investigation include: Semaglutide Injectable Product (Wegovy and/or Ozempic) (DRUG).
Who is sponsoring clinical trial NCT05819853?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05819853 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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