Viagra in the Treatment of Primary Dysmenorrhea
|ClinicalTrials.gov Identifier: NCT00123162|
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dysmenorrhea||Drug: Sildenafil Citrate Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Sildenafil Citrate in the Treatment of Primary Dysmenorrhea|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||August 2011|
Experimental: Sildenafil Citrate
A single vaginal dose of Viagra 100 mg.
Drug: Sildenafil Citrate
A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.
Other Name: Viagra
Placebo Comparator: Placebo
A single vaginal dose of placebo.
A single vaginal dose of placebo and monitored for 4 hours.
Other Name: Sugar Pill
- 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. [ Time Frame: Hours 1, 2, 3 and 4. ]The Total Pain Relief (TOPAR) Scale rates the level of pain relief on a scale of 0=None, 1=Mild, 2=Moderate, 3=Excellent, 4=Complete. The TOPAR scale was completed each hour after administration of study drug for a total of 4 hours. The 4 hourly scores were summed for a final TOPAR4 score that ranged between 0 and 16, with higher values indicating greater pain relief over time. Missing TOPAR scores after the first hour were imputed using the last-observation-carried-forward approach.
- Improvement in Pain Severity Determined by Visual Analog Scale (VAS). [ Time Frame: Each hour of the study (0, 1, 2, 3, 4). ]The Visual Analog Scale (VAS) assesses pain intensity. The scale is 100 mm long; the extremes of the scale are to the left, "no pain" and to the right, "worst pain I have ever felt." The VAS score is determined by measuring the distance (in mm) from the left side of the scale to the point that the patient marked. The score ranges from 0 to 100, with higher values indicating greater pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123162
|Nova Gradiska General Hospital|
|Strossmayerova 17, Zagreb, Croatia|
|Principal Investigator:||Richard Legro, M.D.||Penn State University College of Medicine|