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Viagra in the Treatment of Primary Dysmenorrhea

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00123162
First received: July 20, 2005
Last updated: September 26, 2011
Last verified: September 2011

July 20, 2005
September 26, 2011
May 2007
June 2011   (final data collection date for primary outcome measure)
The primary outcome will be to determine if sildenafil citrate is capable of alleviating pain in primary dysmenorrhea and total pain relief over 4 hours (TOPAR4), comparing a single dose of slidenafil 100 mg to a single dose of placebo. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
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 results. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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 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: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Dysmenorrhea
  • Drug: Viagra
    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.
    Other Name: Slidenafil
  • Drug: Placebo
    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.
    Other Name: Sugar Pill
  • Experimental: 1
    Slidenafil
    Intervention: Drug: Viagra
  • Placebo Comparator: 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
Yes
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT00123162
20477
No
Richard S. Legro, M.D., The Penn State University
Penn State University
National Institutes of Health (NIH)
Principal Investigator: Richard Legro, M.D. Penn State University College of Medicine
Penn State University
September 2011

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