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Viagra in the Treatment of Primary Dysmenorrhea

NCT ID: NCT00123162

Last Updated: 2015-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Dysmenorrhea

Keywords

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Sildenafil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sildenafil Citrate

A single vaginal dose of Viagra 100 mg.

Group Type EXPERIMENTAL

Sildenafil Citrate

Intervention Type DRUG

A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.

Placebo

A single vaginal dose of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A single vaginal dose of placebo and monitored for 4 hours.

Interventions

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Sildenafil Citrate

A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.

Intervention Type DRUG

Placebo

A single vaginal dose of placebo and monitored for 4 hours.

Intervention Type DRUG

Other Intervention Names

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Viagra Sugar Pill

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Richard S. Legro, M.D.

Professor, Obstetrics and Gynecology and Public Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Legro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State University College of Medicine

Locations

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Nova Gradiska General Hospital

Strossmayerova 17, Zagreb, Croatia

Site Status

Countries

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United States Croatia

References

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Dmitrovic R, Kunselman AR, Legro RS. Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2958-65. doi: 10.1093/humrep/det324. Epub 2013 Aug 6.

Reference Type DERIVED
PMID: 23925396 (View on PubMed)

Other Identifiers

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20477

Identifier Type: -

Identifier Source: org_study_id