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Condition / disease
Location
Status: Not yet recruiting

Vaginal Sildenafil for Primary Dysmenorrhea

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.

Participants needed: 50
Trial details
Phase: Phase 1Age: 18-35Biological sex: FemaleType: InterventionalSponsor: Kevin HellmanUpdated: Apr 2, 2026Locations: 1
Eligibility criteria

Female sex assigned at birth [+6]

Known hypersensitivity to sildenafil or any formulation component [+12]