Date Modified

2025-09-25

Period

12/months

Report Summary

Interim per-protocol analysis (n = 57): • Ovulation (Progesterone >20 ng/mL): Significantly higher in Group A (96.9%) compared to Group B (66.7%), RR = 1.45 (95% CI: 1.11–1.91), ?² = 9.86, p = 0.003. • Pregnancy (Urine HCG positivity): Higher in Group A (21.9%) vs Group B (7.4%), RR = 2.96 (95% CI: 0.67–13.05), but not statistically significant (p = 0.12). • Secondary outcomes: Significant improvements were observed in PBLAC scores (p = 0.017) and serum testosterone (p < 0.001) in Group A compared to Group B. No significant differences were noted for FG score or acne score. • BMI reduction: Greater in Group A (mean 0.77, SD 0.59) compared to Group B (mean 0.13, SD 0.40), mean difference = 0.63 (95% CI: 0.35–0.92), p < 0.001. • Side effects: Group A showed more gastrointestinal side effects (nausea, vomiting, diarrhoea), while non-gastrointestinal effects (hot flushes, headache, dizziness, mood changes) were reported in both groups but were not significantly different. • Intention-to-treat analysis (n = 64): confirmed the robustness of findings, with ovulation remaining significantly higher in Group A, while HCG positivity did not reach significance.

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