NCT00123162

Viagra in the Treatment of Primary Dysmenorrhea

Sildenafil Citrate in the Treatment of Primary Dysmenorrhea

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

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 Cyclic guanosine monophosphate (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.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	Sildenafil Citrate	A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.
DRUG	Placebo	A single vaginal dose of placebo and monitored for 4 hours.

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-06-01
• Completion: 2011-08-01
• First posted: 2005-07-22
• Last updated: 2015-12-23
• Results posted: 2015-12-23

Locations

1 site across 1 country: Croatia