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Sponsors and Collaborators: |
Penn State University National Institutes of Health (NIH) |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00123162 |
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 |
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Dysmenorrhea |
Drug: Sildenafil Citrate |
Phase I Phase II |
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 |
Estimated Enrollment: | 62 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2008 |
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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Romana Dmitrovic, M.D. | +385-35-217928 | romana.dmitrovic@zg.htnet.hr |
Contact: Richard Legro, M.D. | 717-531-8478 | rsl1@psu.edu |
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. |
Principal Investigator: | Richard Legro, M.D. | Penn State University College of Medicine |
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 |
Slidenafil |
Signs and Symptoms Pelvic Pain Menstruation Disturbances Dysmenorrhea |
Citric Acid Sildenafil Pain |
Vasodilator Agents Phosphodiesterase Inhibitors Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions |