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Role of semaglutide in restoring ovulation in youth and adults with polycystic ovary syndrome (PCOS) (RESTORE Study)

The purpose of this study is to understand the role of semaglutide, with or without metformin, in restoring ovulation in youth and adults (12-35 years old) with polycystic ovary syndrome.


Why this Research Matters

For this study, participants will complete a screening visit to determine eligibility. They will collect 4-months of daily urine to determine rates of ovulation prior to starting semaglutide treatment. They will complete an oral sugar tolerance test (drink a sugary drink) to measure their body's response to sugar and they will start semaglutide treatment (once-week injection) for 10-months. Participants will be seen every two months for safety labs. At month-6 participants will collect 4-months of daily urine again to measure changes in ovulation. At month 10, they will repeat the oral sugar tolerance test.


Who can Participate

All Ages

To be eligible: Female sex Age 12-35 years old Suspected or Diagnosed PCOS Periods more than 5 weeks apart Not desiring pregnancy in the next 18 months Not using hormonal birth control Struggle with weight Youth BMI >95th percentile Adults BMI >/=27 kg/m2 Contact: PCOSresearch@cuanschutz.edu


Study ID

Protocol Number: 21-4941
More information available at ClinicalTrials.gov: NCT05819853