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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:
Penn State University
ClinicalTrials.gov Identifier:
NCT00123162
First received: July 20, 2005
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  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: Viagra
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sildenafil Citrate in the Treatment of Primary Dysmenorrhea

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in pain severity determined by visual analog scale results. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2007
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Slidenafil
 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
Placebo Comparator: Placebo 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

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

Locations
Croatia
Nova Gradiska General Hospital
Strossmayerova 17, Zagreb, Croatia
Sponsors and Collaborators
Penn State University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Richard Legro, M.D. Penn State University College of Medicine
  More Information

No publications provided

Responsible Party: Richard S. Legro, M.D., The Penn State University
ClinicalTrials.gov Identifier: NCT00123162     History of Changes
Other Study ID Numbers: 20477
Study First Received: July 20, 2005
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Penn State University:
Slidenafil

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013