A Phase 3 study evaluating dapagliflozin as an adjuvant therapy with letrozole for induction of ovulation in women with polycystic ovarian syndrome reached its primary completion on March 30, 2026. The trial enrolled 200 participants to assess the efficacy of various treatment arms.
Background
This study investigated dapagliflozin, metformin, and their combination as adjuvant therapies alongside letrozole for inducing ovulation in women with polycystic ovarian syndrome (PCOS). The trial aimed to compare these interventions against a control group to determine their effectiveness in improving ovulation and pregnancy rates in this patient population.
Trial design
The Phase 3 study (NCT06405178) enrolled 200 participants with polycystic ovarian syndrome. The trial's objective was to assess the efficacy of adjuvant therapy with dapagliflozin, metformin as monotherapy, and a combination of both, in comparison to a control group, for the induction of ovulation with letrozole. The study focused on evaluating rates of ovulation and pregnancy.
What this means
The primary completion of this Phase 3 study indicates that data collection for the primary outcomes in the trial evaluating dapagliflozin, metformin, and their combination as adjuvant therapies for polycystic ovarian syndrome is now complete. However, specific results regarding ovulation and pregnancy rates have not yet been released. Clinicians and researchers will need to await the publication of the trial's findings to understand the efficacy and safety profile of these interventions in this patient population.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06405178, titled "Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome", was updated on March 30, 2026 on clinicaltrials.gov.