Viagra in the Treatment of Primary Dysmenorrhea

This study has been completed.
Sponsor:
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
Results First Received: January 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Dysmenorrhea
Interventions: Drug: Sildenafil Citrate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sildenafil Citrate A single vaginal dose of sildenafil citrate 100 mg.
Placebo A single vaginal dose of placebo.

Participant Flow:   Overall Study
    Sildenafil Citrate     Placebo  
STARTED     13     12  
COMPLETED     13     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sildenafil Citrate A single vaginal dose of sildenafil citrate 100 mg.
Placebo A single vaginal dose of placebo.
Total Total of all reporting groups

Baseline Measures
    Sildenafil Citrate     Placebo     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: years]
Mean (Standard Deviation)
  23.7  (5.7)     23.3  (4.8)     23.5  (5.2)  
Gender  
[units: participants]
     
Female     13     12     25  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     13     12     25  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     13     12     25  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Croatia     13     12     25  



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   Improvement in Pain Severity Determined by Visual Analog Scale (VAS).   [ Time Frame: Each hour of the study (0, 1, 2, 3, 4). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard S Legro MD
Organization: MS Hershey Medical Center
phone: 717-531-8478
e-mail: rsl1@psu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00123162     History of Changes
Other Study ID Numbers: 20477
Study First Received: July 20, 2005
Results First Received: January 16, 2015
Last Updated: November 18, 2015
Health Authority: United States: Food and Drug Administration