SPIOMET4HEALTH —efficacy, tolerability and safety of lifestyle intervention plus a fixed dose combination of spironolactone, pioglitazone and metformin (SPIOMET) for adolescent girls and young women with polycystic ovary syndrome: study protocol for a multicentre, randomised, double-blind, placebo-controlled, fo ur-arm, parallel-group, phase II clinical trial

DiscussionThe present study will be the first to evaluate —in a randomised, double-blind, placebo-controlled way—the efficacy, tolerability and safety of SPIOMET treatment for early PCOS, on top of a lifestyle intervention.Trial registrationEudraCT 2021 –003177-58. Registered on 22 December 2021.https://www.clinicaltrialsregister.eu/ctr-search/search?query=%092021-003177-58.
Source: Trials - Category: Research Source Type: clinical trials