NCT07508358Not yet recruitingPhase 1
Vaginal Sildenafil for Primary Dysmenorrhea
Vaginal Sildenafil for Primary Dysmenorrhea: An Open-Label Mechanistic Study
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
This open-label, non-randomized mechanistic study will evaluate whether a single 100 mg vaginal sildenafil citrate suppository reduces uterine hypercontractility during menstruation in adults with moderate-to-severe dysmenorrhea. Ten participants will each receive one open-label dose during a single menstrual treatment visit and will serve as their own control: 6 participants with primary dysmenorrhea and no evidence of pelvic pathology, plus a separately analyzed exploratory subset of 4 participants, 2 with known endometriosis and 2 with known uterine fibroids. Uterine contractility will be measured with cine magnetic resonance imaging (MRI) before dosing and approximately 4 hours after dosing. Additional objectives are to evaluate acute menstrual pain over the 4-hour observation window, to document systemic exposure using sparse plasma sampling at approximately 2 and 4 hours after dosing, and to assess short-term safety and local tolerability.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 26 Mar 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Kevin Hellman
- Diseases
- Endometriosis
- NCT number
- NCT07508358
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 1 Oct 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any CYP3A4 inhibitor or inducer, including dietary sources such as grapefruit
- Use of another phosphodiesterase type 5 inhibitor
- Use of any alpha-adrenergic blocker or any antihypertensive medication
- Other contraindication to MRI or factors that would impair MRI safety or interpretability, including certain metallic implants, metallic injury, or claustrophobia
Other illness
- Known hypersensitivity to sildenafil or any formulation component
- Uncontrolled hypertension, defined as systolic blood pressure at or above 140 mmHg or diastolic blood pressure at or above 90 mmHg
- Cardiovascular disease
- Severe renal impairment
- Bleeding disorder
- Peptic ulcer disease
- History of non-arteritic anterior ischemic optic neuropathy, risk factors for non-arteritic anterior ischemic optic neuropathy, or other retinal disorders
- Sickle cell disease
- Active pelvic infection
- Any condition that, in the opinion of the investigator, would increase risk or interfere with study participation
Lab values
- Clinically significant laboratory abnormality, as judged by the investigator
- Hepatic impairment of any severity, assessed by screening hepatic laboratory testing and clinical history
- Platelet count below 100,000 per microliter or hemoglobin below 10 g/dL on screening complete blood count
Other
- Gross pelvic pathology identified by clinical history or by the prespecified review of the baseline research MRI. This criterion does not apply to participants enrolled in the prespecified exploratory cohort with known endometriosis or known uterine fibroids, who are analyzed separately.
- Use of nitrates or nitric oxide donors
- Near-hypotension, defined as systolic blood pressure at or below 95 mmHg or diastolic blood pressure at or below 65 mmHg
- Clinically significant electrocardiographic abnormality, as judged by the investigator
- Presence of an intrauterine device, because of MRI artifact affecting interpretability
- Pregnant or breastfeeding
Who the study is looking for
- Female sex assigned at birth
- Age 18 to 35 years
- History of moderate-to-severe dysmenorrhea
- Regular menstrual cycles of approximately 21 to 35 days
- Willing and able to complete a single menstrual treatment visit
- Able to comply with study procedures, including MRI procedures and vaginal self-administration of study product
- Able to provide informed consent
Age in the registry: 18 years to 35 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Evanston Hospital Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.