Vaginal Sildenafil for Primary Dysmenorrhea

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Dysmenorrhea, Menstrual Pain

In brief

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 facts

Study ID

NCT07508358

Run by

Kevin Hellman

People needed

50

Starts

2026-05-01

Expected to finish

2027-10-01

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female sex assigned at birth
• Age 18 to 35 years
• History of moderate-to-severe primary dysmenorrhea
• Regular menstrual cycles of approximately 21 to 35 days
• Willing and able to complete 2 menstrual treatment visits in separate menstrual cycles
• Able to provide informed consent
• Able to comply with study procedures, including MRI procedures and vaginal self-administration of study product

You may not qualify if…

• Known hypersensitivity to sildenafil or any formulation component
• Current use of nitrates or nitric oxide donors
• Current use of potent CYP3A4 inhibitors or potent CYP3A4 inducers
• Current use of another phosphodiesterase type 5 inhibitor
• Uncontrolled hypertension, near-hypotension, or other clinically significant hemodynamic instability
• Clinically significant cardiovascular disease
• Clinically significant electrocardiographic abnormality, as judged by the investigator
• Clinically significant laboratory abnormality, as judged by the investigator
• Severe hepatic impairment or severe renal impairment
• Active pelvic infection
• Contraindication to MRI or factors that would impair MRI safety or interpretability, including certain metallic implants, metallic injury, claustrophobia, or intrauterine device-related artifact
• Pregnant or breastfeeding
• Any condition that, in the opinion of the investigator, would increase risk or interfere with study participation

Where it is running

• Evanston Hospital — Evanston, Illinois, United States

Full record on ClinicalTrials.gov

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