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Vaginal Sildenafil for Primary Dysmenorrhea

NCT07508358 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Dysmenorrhea
  • Menstrual Pain

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.

Sponsors & Collaborators

  • Kevin Hellman

    lead OTHER

Principal Investigators

  • Frank Tu, MD, MPH · EndeavorHealth, Department of Obstetrics & Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07508358 on ClinicalTrials.gov