Clinical trial · Interventional
Vaginal Sildenafil for Primary Dysmenorrhea
Vaginal Sildenafil for Primary Dysmenorrhea: An Open-Label Mechanistic Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysmenorrhea | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Menstrual Pain | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sildenafil citrate vaginal suppository | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open-label vaginal sildenafil
- description
- All participants receive a single open-label 100 mg vaginal sildenafil citrate suppository during one menstrual treatment visit, self-administered after the pre-dose MRI. Uterine contractility, pain ratings, vital signs, and plasma concentrations are assessed before and after dosing within the same visit.
- interventionNames
- Drug: Sildenafil citrate vaginal suppository
Primary outcomes (1)
- measure
- Change from baseline in number of uterine contractions during a 10-minute cine MRI acquisition
- timeFrame
- Baseline (pre-dose) and approximately 4 hours after dosing
- description
- Uterine contractility will be quantified as the number of uterine contractions observed during a standardized 10-minute cine MRI acquisition. The primary analysis is the within-participant change from pre-dose baseline after a single open-label 100 mg vaginal dose of sildenafil citrate. A decrease indicates reduced uterine contractility.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Known hypersensitivity to sildenafil or any formulation component * Use of nitrates or nitric oxide donors * 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 * Uncontrolled hypertension, defined as systolic blood pressure at or above 140 mmHg or diastolic blood pressure at or above 90 mmHg * Near-hypotension, defined as systolic blood pressure at or below 95 mmHg or diastolic blood pressure at or below 65 mmHg * Cardiovascular disease * Clinically significant electrocardiographic abnormality, as judged by the investigator * Clinically significant laboratory abnormality, as judged by the investigator * Hepatic impairment of any severity, assessed by screening hepatic laboratory testing and clinical history * Severe renal impairment * Platelet count below 100,000 per microliter or hemoglobin below 10 g/dL on screening complete blood count * 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 * Presence of an intrauterine device, because of MRI artifact affecting interpretability * Other contraindication to MRI or factors that would impair MRI safety or interpretability, including certain metallic implants, metallic injury, or claustrophobia * Pregnant or breastfeeding * Any condition that, in the opinion of the investigator, would increase risk or interfere with study participation
References
Publications (0)
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