Vaginal Sildenafil for Primary Dysmenorrhea

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Kevin Hellman
Study ID
NCT07508358
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Dysmenorrhea
  • Menstrual Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Sildenafil citrate vaginal suppository — DRUG
    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 — DRUG
    A single matched placebo vaginal suppository without active sildenafil is administered during one treatment period of the crossover study.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Vaginal sildenafil
    Participants receive a single 100 mg vaginal sildenafil citrate suppository during one menstrual treatment visit. In the crossover design, the same participants receive matching placebo during the other menstrual treatment visit.
  • Placebo Comparator: Placebo
    Participants receive a single matched placebo vaginal suppository during one menstrual treatment visit. In the crossover design, the same participants receive vaginal sildenafil during the other menstrual treatment visit.

Primary Outcome Measure

Change from baseline in uterine contractions measured by cine MRI [ Time Frame: Baseline, approximately 2 hours after dosing, and approximately 4 hours after dosing during each treatment visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Evanston HospitalEvanstonIllinois60201
Frank Tu, MD, MPH
[email protected]
847-644-0494
Kevin
Frank Tu, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Evanston Hospital· Evanston, IL

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