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Treating PCOS with Semaglutide vs Active Lifestyle Intervention (TEAL Study)
Description
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.
Details
Age
Child to Adult
Eligibility
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.
Phase
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.
Type of Study
Treatment
Locations
Childrens Hospital Colorado
Outpatient CTRC
University of Colorado Hospital
Principal Investigator
Melanie Green, MD, PhD
Study ID
Protocol Number: 19-0636
More information available at ClinicalTrials.gov: NCT03919929
Categories
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