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Could a vaginal pill ease severe period cramps?

NCT ID NCT07508358

Symptom relief Sponsor: Kevin Hellman Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether a single vaginal dose of sildenafil (100 mg) can reduce painful uterine contractions during menstruation. About 50 adults with moderate-to-severe period pain will receive the drug or a placebo in two separate cycles. The study uses MRI to measure contractions and tracks pain relief over 4 hours.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

dysmenorrhea Pelvic Pain primary dysmenorrhea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysmenorrhea Menstrual pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Evanston Hospital

    Evanston, Illinois, 60201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.