Viagra in the Treatment of Primary Dysmenorrhea
This study has been completed.
Sponsor:
Milton S. Hershey Medical Center
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00123162
First received: July 20, 2005
Last updated: November 18, 2015
Last verified: November 2015
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| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | July 20, 2005 | |||
| Last Updated Date | November 18, 2015 | |||
| Start Date ICMJE | May 2007 | |||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo. [ Time Frame: Hours 1, 2, 3 and 4. ] [ Designated as safety issue: No ] The Total Pain Relief (TOPAR) Scale rates the level of pain relief on a scale of 0=None, 1=Mild, 2=Moderate, 3=Excellent, 4=Complete. The TOPAR scale was completed each hour after administration of study drug for a total of 4 hours. The 4 hourly scores were summed for a final TOPAR4 score that ranged between 0 and 16, with higher values indicating greater pain relief over time. Missing TOPAR scores after the first hour were imputed using the last-observation-carried-forward approach. |
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| Original Primary Outcome Measures ICMJE |
Determine if sildnafil citrate is capable of alleviating pain in primary dysmenorrhea. The primary outcome will be total pain relief over 4 hours. | |||
| Change History | Complete list of historical versions of study NCT00123162 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Improvement in Pain Severity Determined by Visual Analog Scale (VAS). [ Time Frame: Each hour of the study (0, 1, 2, 3, 4). ] [ Designated as safety issue: No ] The Visual Analog Scale (VAS) assesses pain intensity. The scale is 100 mm long; the extremes of the scale are to the left, "no pain" and to the right, "worst pain I have ever felt." The VAS score is determined by measuring the distance (in mm) from the left side of the scale to the point that the patient marked. The score ranges from 0 to 100, with higher values indicating greater pain. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Viagra in the Treatment of Primary Dysmenorrhea | |||
| Official Title ICMJE | Sildenafil Citrate in the Treatment of Primary Dysmenorrhea | |||
| Brief 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Dysmenorrhea | |||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Dmitrovic R, Kunselman AR, Legro RS. Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2958-65. doi: 10.1093/humrep/det324. Epub 2013 Aug 6. | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 25 | |||
| Completion Date | August 2011 | |||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | |||
| Ages | 18 Years to 35 Years (Adult) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Croatia | |||
| Removed Location Countries | United States | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00123162 | |||
| Other Study ID Numbers ICMJE | 20477 | |||
| Has Data Monitoring Committee | No | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Richard S. Legro, M.D., Milton S. Hershey Medical Center | |||
| Study Sponsor ICMJE | Milton S. Hershey Medical Center | |||
| Collaborators ICMJE | National Institutes of Health (NIH) | |||
| Investigators ICMJE |
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| Information Provided By | Milton S. Hershey Medical Center | |||
| Verification Date | November 2015 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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