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

Study acronym: RESTORE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Aug 21, 2025, no change to tracked fieldsv9-v10
  2. Interventions: Metformin and Semaglutide(Wegovy and/or Ozempic) (Drug), Semaglutide Injectable Product (Wegovy and/or Ozempic) (Drug) to Semaglutide Injectable Product (Wegovy and/or Ozempic) (Drug)v8
  3. Primary endpoint revised Interventions: Metformin and Wegovy (Drug), Wegovy Injectable Product (Drug) to Metformin and Semaglutide(Wegovy and/or Ozempic) (Drug), Semaglutide Injectable Product (Wegovy and/or Ozempic) (Drug) · Eligibility criteria expanded, about 51 words · Secondary endpoints expanded, about 10 wordsv7 Show 3 more changesShow less
    • Interventions: Metformin and Wegovy (Drug), Wegovy Injectable Product (Drug) to Metformin and Semaglutide(Wegovy and/or Ozempic) (Drug), Semaglutide Injectable Product (Wegovy and/or Ozempic) (Drug)
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  4. Collaborators expanded, about 12 wordsv6 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Completion date: Feb 1, 2028 to Jun 30, 2028 · Start date changed from estimate of Sep 1, 2023 to Nov 3, 2023v5 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Completion date: Feb 1, 2028 to Jun 30, 2028
    • Start date changed from estimate of Sep 1, 2023 to Nov 3, 2023
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Interventions: Wegovy Injectable Product (Drug) to Metformin and Wegovy (Drug), Wegovy Injectable Product (Drug)v3
  3. Interventions: Semaglutide (Drug) to Wegovy Injectable Product (Drug) Eligibility criteria expanded, about 460 words · Study description expanded, about 104 wordsv2 Show 2 more changesShow less
    • Eligibility criteria expanded, about 460 words
    • Study description expanded, about 104 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05819853
Lead Sponsor University of Colorado, Denver
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Obese
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov