Viagra in the Treatment of Primary Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

Sildenafil Citrate in the Treatment of Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123162
• Other study ID #: 20477
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 20, 2005
• Last updated: November 18, 2015
• Start date: May 2007
• Est. completion date: August 2011

Study information

• Verified date: November 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Primary dysmenorrhea at current visit, with a visual analogue scale (VAS) score of >35; pain defined as moderate or severe on a categorical of none, mild, moderate, severe.

Exclusion Criteria:

• Secondary dysmenorrhea

• Any current medication

• Serious medical condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• Sildenafil Citrate
A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.
• Placebo
A single vaginal dose of placebo and monitored for 4 hours.

Locations

Country	Name	City	State
Croatia	Nova Gradiska General Hospital	Strossmayerova 17	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	Hours 1, 2, 3 and 4.	No
Secondary	Improvement in Pain Severity Determined by Visual Analog Scale (VAS).	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.	Each hour of the study (0, 1, 2, 3, 4).	No