Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Viagra in the Treatment of Primary Dysmenorrhea
This study is currently recruiting participants.
Verified by Penn State University, May 2007
Sponsors and Collaborators: Penn State University
National Institutes of Health (NIH)
Information provided by: Penn State University
ClinicalTrials.gov Identifier: NCT00123162
  Purpose

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.


Condition Intervention Phase
Dysmenorrhea
Drug: Sildenafil Citrate
Phase I
Phase II

Drug Information available for: Sildenafil citrate Sildenafil Citric acid Sodium Citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Sildenafil Citrate in the Treatment of Primary Dysmenorrhea

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Improvement in pain severity determined by visual analog scale results. [ Time Frame: 4 hours ]

Estimated Enrollment: 62
Study Start Date: May 2007
Estimated Study Completion Date: June 2008
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123162

Contacts
Contact: Romana Dmitrovic, M.D. +385-35-217928 romana.dmitrovic@zg.htnet.hr
Contact: Richard Legro, M.D. 717-531-8478 rsl1@psu.edu

Locations
Croatia, Zagreb
Nova Gradiska General Hospital Recruiting
Strossmayerova 17, Zagreb, Croatia
Contact: Romana Dmitrovic, M.D.     385-35-217928     romana.dmitrovic@zg.htnet.hr    
Contact: Sandra Eyer     717-531-1540     seyer@psu.edu    
Principal Investigator: Richard Legro, M.D.            
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Richard Legro, M.D. Penn State University College of Medicine
  More Information

Study ID Numbers: 20477
Study First Received: July 20, 2005
Last Updated: August 15, 2007
ClinicalTrials.gov Identifier: NCT00123162  
Health Authority: United States: Food and Drug Administration

Keywords provided by Penn State University:
Slidenafil

Study placed in the following topic categories:
Signs and Symptoms
Pelvic Pain
Menstruation Disturbances
Dysmenorrhea
Citric Acid
Sildenafil
Pain

Additional relevant MeSH terms:
Vasodilator Agents
Phosphodiesterase Inhibitors
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009