This phase 1 randomized, double-blind, placebo-controlled, two-period crossover trial will evaluate whether a single 100 mg vaginal sildenafil citrate suppository reduces uterine hypercontractility during menstruation in adults with moderate-to-severe dysmenorrhea. Uterine contractility will be measured using cine magnetic resonance imaging (MRI). Key secondary objectives are to evaluate acute menstrual pain reduction over 4 hours, characterize limited systemic exposure using a single 4-hour plasma sildenafil concentration, and assess short-term safety and tolerability.
Age range
18 Years – 35 Years
Sex
FEMALE
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Change from baseline in uterine contractions measured by cine MRI
Timeframe: Baseline, approximately 2 hours after dosing, and approximately 4 hours after dosing during each treatment visit