Role of semaglutide in restoring ovulation in youth and adults with polycystic ovary syndrome (PCOS) (RESTORE Study)
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.
MoreChild to Adult
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
Treatment
Childrens Hospital Colorado
Outpatient CTRC
Melanie Cree
Protocol Number: 21-4941
More information available at ClinicalTrials.gov: NCT05819853
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