Viagra in the Treatment of Primary Dysmenorrhea - Full Text View

Sponsor:	Penn State University
Collaborator:	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: Viagra Drug: Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Sildenafil Citrate in the Treatment of Primary Dysmenorrhea

Resource links provided by NLM:

Drug Information available for: Sildenafil Sildenafil citrate

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 ]

Estimated Enrollment:	62
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
Placebo: Placebo Comparator	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.

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

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:	The Penn State University ( Richard S. Legro, M.D. )
Study ID Numbers:	20477
Study First Received:	July 20, 2005
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00123162 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

Slidenafil

Additional relevant MeSH terms:

Dysmenorrhea
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Pain
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents

Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Pelvic Pain
Phosphodiesterase Inhibitors
Menstruation Disturbances
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2009