Vaginal Sildenafil for Menstrual Pain

(SILDYS Trial)

Overseen By Kevin Hellman, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Kevin Hellman

Must not be taking: Nitrates, CYP3A4 inhibitors, others

Disqualifiers: Hypertension, Cardiovascular disease, others

Compensation: Varies

Number of Visits: 9

Duration: 2 menstrual cycles

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Frank Tu, MD, MPH

Principal Investigator

EndeavorHealth, Department of Obstetrics & Gynecology

Are You a Good Fit for This Trial?

Inclusion Criteria

I was assigned female at birth.

I am between 18 and 35 years old.

* History of moderate-to-severe primary dysmenorrhea

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants undergo two menstrual treatment visits in a crossover design, receiving either vaginal sildenafil or placebo, with MRI assessments and pain evaluations.

2 menstrual cycles

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event assessments and hemodynamic tolerability.

24 hours after each treatment visit

Electronic side-effect questionnaires at 6 and 24 hours after dosing

What Are the Treatments Tested in This Trial?

Interventions

• Sildenafil citrate vaginal suppository

How Is the Trial Designed?

Group I: Vaginal sildenafil Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Kevin Hellman

Lead Sponsor