The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study.
Child to Adult
12-21 year old girls/young women with PCOS (polycystic ovary syndrome) Cannot be taking metformin or hormonal contraception (as well as other medications that lower blood sugars) Cannot have diabetes Cannot be doing more than 2 hours of physical activity per week.
Detailed Eligibility: Contact our study team to see if you're eligible to participate in our study.
III/IV - A combination of phases: (3) Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. and (4) Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.
Treatment
Childrens Hospital Colorado
University of Colorado Hospital
Melanie Green, MD, PhD
Protocol Number: 19-0636
More information available at ClinicalTrials.gov: NCT03919929
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