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Viagra in the Treatment of Primary Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00123162
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Dysmenorrhea
Interventions: Drug: Sildenafil Citrate
Drug: Placebo

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 13   12   25 
[Units: Years]
Mean (Standard Deviation)
 23.7  (5.7)   23.3  (4.8)   23.5  (5.2) 
[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

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

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

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
First Submitted: July 20, 2005
First Posted: July 22, 2005
Results First Submitted: January 16, 2015
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015