About this trial
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.
Eligibility criteria
Qualifiers
Female sex assigned at birth
Age 18 to 35 years
History of moderate-to-severe primary dysmenorrhea
Regular menstrual cycles of approximately 21 to 35 days
Disqualifiers
Known hypersensitivity to sildenafil or any formulation component
Current use of nitrates or nitric oxide donors
Current use of potent CYP3A4 inhibitors or potent CYP3A4 inducers
Current use of another phosphodiesterase type 5 inhibitor
Trial design
Treatments tested in this trial
- Sildenafil citrate vaginal suppository
- Placebo vaginal suppository
Treatment groups
Sponsors and collaborators
Kevin Hellman
Lead sponsor
Endeavor Health
Sponsor institution