The Effects of Adjunctive Nimesulide on Androgen and Gonadotropin Profiles in Women with PCOS: A Controlled Clinical Study

Background & Objective: Polycystic Ovary Syndrome (PCOS) features dysregulated gonadotropins and hyperandrogenism. The present study was conducted with aim to evaluate whether adding the selective COX-2 inhibitor nimesulide to metformin improves androgen and gonadotropin profiles versus metformin alone in women with PCOS.Materials & Methods: This prospective controlled study was conducted on 100 reproductive-age women with PCOS who completed 3 weeks of therapy with either metformin alone (500 mg three timesdaily) or metformin plus nimesulide (100 mg twice daily). The participants were recruited from the hospital and daily clinic in Basrah and Misan. The primary outcome was change in total and free testosterone, LH, FSH and secondary outcomes included Dehydroepiandrosterone Sulfate (DHEA-S), as well as selected inflammatory and lipid indices.Results: Both groups showed significant reductions in total testosterone (P<0.001) and free testosterone (P=0.001) and LH (P<0.001), with greater improvements in the combination group. FSH increased significantly (P<0.001) after combination therapy. DHEA-S levels don’t differ significantly in both groups (P=0.375). Post-treatment, FSH was significantly higher in the combination group (P=0.003), while other hormonal differences were not statistically significant.Conclusion: Over 3 weeks, metformin improved androgen excess and gonadotropin imbalance in PCOS, and adjunctive nimesulide amplified within-group hormonal shifts and selectively increased FSH. These findings support short-course anti-inflammatory co-treatment to augment endocrine benefits of metformin and motivate longer randomized trials. Clinical endpoints warrant assessment over extended follow-up periods.