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NOT YET RECRUITING
NCT07508358
PHASE1

Vaginal Sildenafil for Primary Dysmenorrhea

Sponsor: Kevin Hellman

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.

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

Interventions

DRUG

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.

DRUG

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