Viagra in the Treatment of Primary Dysmenorrhea

Tracking Information
First Submitted Date ICMJE	July 20, 2005
First Posted Date ICMJE	July 22, 2005
Results First Submitted Date	January 16, 2015
Results First Posted Date	December 23, 2015
Last Update Posted Date	December 23, 2015
Study Start Date ICMJE	May 2007
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 18, 2015)	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.
Original Primary Outcome Measures ICMJE; (submitted: July 20, 2005)	Determine if sildnafil citrate is capable of alleviating pain in primary dysmenorrhea. The primary outcome will be total pain relief over 4 hours.
Change History	Complete list of historical versions of study NCT00123162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 18, 2015)	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.
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Viagra in the Treatment of Primary Dysmenorrhea
Official Title ICMJE	Sildenafil Citrate in the Treatment of Primary Dysmenorrhea
Brief 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.
Detailed Description	It is well established that excess prostaglandin production in primary dysmenorrhea leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid anti-inflammatory drugs (NSAIDS) being the most effective with the overall success rate of more than 75%. Sildenafil citrate (Viagra) is an inhibitor that augments the vasodilatory effects of nitric oxide by preventing the degradation of Cyclic guanosine monophosphate (cGMP) in the uterine muscle. Sildenafil is commonly used in the treatment of male erectile dysfunction, pulmonary hypertension in children and adults, and in vitro fertilization. To date it has not been used in the treatment of primary dysmenorrhea.
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Dysmenorrhea
Intervention ICMJE	Drug: Sildenafil Citrate A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours. Other Name: Viagra; Drug: Placebo A single vaginal dose of placebo and monitored for 4 hours. Other Name: Sugar Pill
Study Arms	Experimental: Sildenafil Citrate A single vaginal dose of Viagra 100 mg. Intervention: Drug: Sildenafil Citrate; Placebo Comparator: Placebo A single vaginal dose of placebo. Intervention: Drug: Placebo
Publications *	Dmitrovic R, Kunselman AR, Legro RS. Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2958-65. doi: 10.1093/humrep/det324. Epub 2013 Aug 6.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 26, 2011)	25
Original Enrollment ICMJE; (submitted: July 20, 2005)	40
Actual Study Completion Date	August 2011
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 35 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Croatia
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT00123162
Other Study ID Numbers ICMJE	20477
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Richard S. Legro, M.D., Milton S. Hershey Medical Center
Study Sponsor ICMJE	Milton S. Hershey Medical Center
Collaborators ICMJE	National Institutes of Health (NIH)
Investigators ICMJE	Principal Investigator: Richard Legro, M.D. Penn State University College of Medicine
PRS Account	Milton S. Hershey Medical Center
Verification Date	November 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP