Viagra in the Treatment of Primary Dysmenorrhea

Phase 1

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: Sildenafil Citrate; Drug: Placebo

• Registration Number: NCT00123162
• Lead Sponsor: Milton S. Hershey Medical Center

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 Timeline

• Study First Submitted: 2005-07-20
• Study First Submitted QC: 2005-07-20
• Study First Posted: 2005-07-22
• Study Start: 2007-05
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Results First Submitted: 2015-01-16
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-18
• Last Update Submitted: 2015-11-18
• Results First Posted: 2015-12-23
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil Citrate	Sildenafil Citrate	A single vaginal dose of Viagra 100 mg.
Placebo	Placebo	A single vaginal dose of placebo.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in Pain Severity Determined by Visual Analog Scale (VAS).	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.

Trial Locations

Locations (1)

Nova Gradiska General Hospital; 🇭🇷 Strossmayerova 17, Zagreb, Croatia