Trial Outcomes & Findings for Viagra in the Treatment of Primary Dysmenorrhea (NCT NCT00123162)
NCT ID: NCT00123162
Last Updated: 2015-12-23
Results Overview
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.
COMPLETED
PHASE1/PHASE2
25 participants
Hours 1, 2, 3 and 4.
2015-12-23
Participant Flow
Participant milestones
| Measure |
Sildenafil Citrate
A single vaginal dose of sildenafil citrate 100 mg.
|
Placebo
A single vaginal dose of placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Viagra in the Treatment of Primary Dysmenorrhea
Baseline characteristics by cohort
| Measure |
Sildenafil Citrate
n=13 Participants
A single vaginal dose of sildenafil citrate 100 mg.
|
Placebo
n=12 Participants
A single vaginal dose of placebo.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.7 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
23.3 years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
23.5 years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
25 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Hours 1, 2, 3 and 4.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.
Outcome measures
| Measure |
Sildenafil Citrate
n=13 Participants
A single vaginal dose of sildenafil citrate 100 mg.
|
Placebo
n=12 Participants
A single vaginal dose of placebo.
|
|---|---|---|
|
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.
|
11.9 units on a scale
Standard Deviation 3.2
|
6.4 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Each hour of the study (0, 1, 2, 3, 4).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.
Outcome measures
| Measure |
Sildenafil Citrate
n=13 Participants
A single vaginal dose of sildenafil citrate 100 mg.
|
Placebo
n=12 Participants
A single vaginal dose of placebo.
|
|---|---|---|
|
Improvement in Pain Severity Determined by Visual Analog Scale (VAS).
Hour 0
|
91.2 mm
Standard Deviation 11.2
|
95.6 mm
Standard Deviation 5.3
|
|
Improvement in Pain Severity Determined by Visual Analog Scale (VAS).
Hour 1
|
65.2 mm
Standard Deviation 21.2
|
88.6 mm
Standard Deviation 10.9
|
|
Improvement in Pain Severity Determined by Visual Analog Scale (VAS).
Hour 2
|
23.4 mm
Standard Deviation 25.3
|
72.5 mm
Standard Deviation 11.8
|
|
Improvement in Pain Severity Determined by Visual Analog Scale (VAS).
Hour 3
|
13.8 mm
Standard Deviation 25.3
|
58.5 mm
Standard Deviation 19.8
|
|
Improvement in Pain Severity Determined by Visual Analog Scale (VAS).
Hour 4
|
8.8 mm
Standard Deviation 25.0
|
51.4 mm
Standard Deviation 26.6
|
Adverse Events
Sildenafil Citrate
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place