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Viagra in the Treatment of Primary Dysmenorrhea

Penn State Health logo

Penn State Health

Status and phase

Completed
Phase 2
Phase 1

Conditions

Dysmenorrhea

Treatments

Drug: Sildenafil Citrate
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

25 participants in 2 patient groups, including a placebo group

Sildenafil Citrate
Experimental group
Description:
A single vaginal dose of Viagra 100 mg.
Treatment:
Drug: Sildenafil Citrate
Placebo
Placebo Comparator group
Description:
A single vaginal dose of placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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