Clinical Trial

Vaginal Sildenafil for Primary Dysmenorrhea

Study acronym: SILDYS
Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07508358
Lead Sponsor Kevin Hellman
Conditions Dysmenorrhea, Menstrual Pain
Enrollment 50 participants
Start Date 2026-05
Primary Completion 2027-05 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-02