Clinical Research Directory
Browse clinical research sites, groups, and studies.
Vaginal Sildenafil for Primary Dysmenorrhea
Sponsor: Kevin Hellman
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.
Official title: Vaginal Sildenafil for Primary Dysmenorrhea: A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Mechanistic Study
Key Details
Gender
FEMALE
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-05
Completion Date
2027-10
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Sildenafil citrate vaginal suppository
A single 100 mg vaginal sildenafil citrate suppository compounded in an emulsifying MBK base is administered during one treatment period of the crossover study.
Placebo vaginal suppository
A single matched placebo vaginal suppository without active sildenafil is administered during one treatment period of the crossover study.
Locations (1)
Evanston Hospital
Evanston, Illinois, United States