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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: Recruiting Phase 3 study of Obese and PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The change in ovulation will be measured at baseline and 6-10 months post treatment with semaglutide from 4 months daily urinary progesterone metabolites
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 |
What NCT05819853 shows while recruiting
NCT05819853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 209-participant average among 27 other Obese trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Obese
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05819853's enrollment target sits among peer trials
80 19th of 27 higher than 9 of 27 other Obese trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obese trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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