Phase 2
N=25
Viagra in the Treatment of Primary Dysmenorrhea
Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT00123162 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo. — 11.9; 6.4 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sildenafil Citrate (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo. |
11.9; 6.4 | <0.001 sig |
| SECONDARY Improvement in Pain Severity Determined by Visual Analog Scale (VAS). |
91.2; 95.6; 65.2; 88.6; 23.4; 72.5 | <.001 sig |
Summary
The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a higher improvement rate when compared to placebo in the treatment of moderate to severe primary dysmenorrhea.
Eligibility Criteria
Inclusion Criteria
- Primary dysmenorrhea at current visit, with a visual analogue scale (VAS) score of >35; pain defined as moderate or severe on a categorical of none, mild, moderate, severe.
Exclusion Criteria
- Secondary dysmenorrhea
- Any current medication
- Serious medical condition
Data sourced from ClinicalTrials.gov (NCT00123162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.