Condition: Polycystic Ovary Syndrome (PCOS) · Obesity & Overweight · Sponsor: University of Bonn
This clinical study examines whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome (PCOS) who are overweight or have obesity. Tirzepatide is already approved for the treatment of diabetes and obesity, but its effects on ovarian dysfunction in PCOS are not yet known. Participants will be randomly assigned to tirzepatide or placebo in a double-blinded manner. The goal of the study is to demonstrate that tirzepatide, at the maximum tolerated dose, is superior to placebo for improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS. All participants will have a screening visit, followed by 72 weeks of treatment. Treatment includes a 20-week dose-escalation period and a 52-week maintenance period. Lower doses may be used if side effects occur, and the highest tolerated dose will be continued through the maintenance phase. A 4-week safety follow-up will take place after treatment, and long-term follow-up will continue for one year. The study will take place at five clinical trial sites in Germany.
This description comes directly from the study's public registry record.
Wiebke Fenske K. Head of Department at BG Universitätsklinikum Bochum, Professor · +49 234 302 3613 · wiebke.fenske@bergmannsheil.de
Charlotte Fries M. Senior Physician, MD · +49 228 287 52533 · charlotte.fries@ukbonn.de
Always discuss trial participation with your own doctor first.
| University Hospital BG Bergmannsheil Bochum General internal medicine, endocrinology and diabetology, gastroenterology and hepatology | Bochum, Germany | Enrolling By Invitation |
| University Hospital Bonn Division of Endocrinology, Diabetes and Metabolism | Bonn, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07326111