Vaginal Sildenafil for Primary Dysmenorrhea

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorKevin Hellman

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

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kevin Hellman

Lead sponsor

Endeavor Health

Sponsor institution