The primary hypothesis is that 100mg single dose of sildenafil will have a higher improvement rate compared to placebo in the treatment of moderate to severe primary dysmenorrhea

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

Further Study Details: 

Primary Outcomes: Determine if sildnafil citrate is capable of alleviating pain in primary dysmenorrhea. The primary outcome will be total pain relief over 4 hours.
Expected Total Enrollment:  40

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 indysmenorrhea 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.

Ages Eligible for Study:  18 Years   -   35 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Primary dysmenorrhea at current visit, with a 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00123162

Jamie Ober, R.N.      717-531-6272    jober@psu.edu
Sandy Eyer      717-531-1540    seyer@psu.edu

Pennsylvania
      Penn State Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting

Study chairs or principal investigators

Richard Legro, M.D.,  Principal Investigator,  Penn State University College of Medicine   

Study ID Numbers:  20477
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00123162
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26