Vaginal Sildenafil for Primary Dysmenorrhea
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorKevin Hellman
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Sildenafil citrate vaginal suppository
DrugA single 100 mg vaginal sildenafil citrate suppository compounded in an emulsifying MBK base is administered during one treatment period of the crossover study.
Placebo vaginal suppository
DrugA single matched placebo vaginal suppository without active sildenafil is administered during one treatment period of the crossover study.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Vaginal sildenafilExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in uterine contractions measured by cine MRI
Uterine contractility will be quantified as the number of uterine contractions observed during a standardized 10-minute cine MRI acquisition. The primary analysis will compare the within-participant change from baseline after vaginal sildenafil versus placebo in the 2-period crossover design.
Time frame
Baseline, approximately 2 hours after dosing, and approximately 4 hours after dosing during each treatment visitSecondary outcomes
1
Menstrual pain intensity AUC from 0 to 4 hours measured by 100-mm visual analog scale
Menstrual pain intensity will be recorded using a 100-mm visual analog scale, where 0 indicates no pain and 100 indicates worst imaginable pain. Area under the curve from 0 to 4 hours will be calculated using the trapezoidal method; lower values indicate lower overall pain burden.
Time frame
Baseline through approximately 4 hours after dosing during each treatment visit2
Plasma sildenafil concentration
A single venous plasma sample will be collected approximately 4 hours after study drug administration to characterize detectable systemic exposure after vaginal dosing and support exploratory exposure-response analyses.
Time frame
Approximately 4 hours after dosing during each treatment visit3
Change from baseline in systolic blood pressure
Hemodynamic tolerability will be assessed by change from baseline in systolic blood pressure measured during each treatment visit.
Time frame
Baseline, approximately 2 hours after dosing, and approximately 4 hours after dosing during each treatment visit4
Change from baseline in diastolic blood pressure
Hemodynamic tolerability will be assessed by the change from baseline in diastolic blood pressure measured during each treatment visit.
Time frame
Baseline, approximately 2 hours after dosing, and approximately 4 hours after dosing during each treatment visitOther outcomes
1
Treatment-emergent adverse events and local vaginal tolerability
Adverse events and symptoms potentially related to PDE5 inhibition or vaginal administration, including headache, flushing, dizziness or lightheadedness, visual disturbances, palpitations, syncope, vaginal irritation, local discomfort, abnormal discharge, and acute changes in bleeding, will be collected during the treatment visit and by electronic side-effect questionnaires at 6 and 24 hours after dosing.
Time frame
From study drug administration through 24 hours after each treatment visit2
Association between change in uterine contractility and change in menstrual pain intensity
An exploratory mechanistic analysis will evaluate whether attenuation of uterine hypercontractility is associated with reduction in menstrual pain intensity during the acute observation window.
Time frame
Baseline through 4 hours after study drug administration during each menstrual treatment visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kevin Hellman
Lead sponsor
Endeavor Health
Sponsor institution
Source ClinicalTrials.gov
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