Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age12-35
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
Qualifiers
Female
Ages 12-35 years
Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.
Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines
Disqualifiers
Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening. - Per approved drug label
Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of the study), chronic oral steroids, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, estrogen-containing hormonal contraception (cannot have been used in the 6 months prior to screening), progesterone-containing hormonal contraception (cannot have been used in the 3 months prior to screening). Dermal patch or vaginal ring contraception methods. Weight loss medications or stimulants. Use of other products containing other GLP-1 agonists.
Weight loss medications in the last 6 months
Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
Trial design
Treatments tested in this trial
- Semaglutide Injectable Product (Wegovy and/or Ozempic)
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov