Phase 2 Completed N=25 Randomized Single-blind Treatment

Viagra in the Treatment of Primary Dysmenorrhea

Source: ClinicalTrials.gov NCT00123162 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcomePrimary: 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

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.