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Viagra in the Treatment of Primary Dysmenorrhea

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00123162
First received: July 20, 2005
Last updated: November 18, 2015
Last verified: November 2015

July 20, 2005
November 18, 2015
May 2007
June 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Determine if sildnafil citrate is capable of alleviating pain in primary dysmenorrhea. The primary outcome will be total pain relief over 4 hours.
Complete list of historical versions of study NCT00123162 on ClinicalTrials.gov Archive Site
Improvement in Pain Severity Determined by Visual Analog Scale (VAS). [ Time Frame: Each hour of the study (0, 1, 2, 3, 4). ] [ Designated as safety issue: No ]
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.
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Viagra in the Treatment of Primary Dysmenorrhea
Sildenafil Citrate in the Treatment of Primary Dysmenorrhea
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Dysmenorrhea
  • 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
  • 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
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.
 
Completed
25
August 2011
June 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Croatia
United States
 
NCT00123162
20477
No
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Richard S. Legro, M.D., Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
National Institutes of Health (NIH)
Principal Investigator: Richard Legro, M.D. Penn State University College of Medicine
Milton S. Hershey Medical Center
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP