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To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

C

Colleen Stockdale

Status

Terminated

Conditions

Vulvar Pain Symptoms
Vulvodynia (Chronic Vulvar Pain)

Treatments

Drug: Gabapentin
Drug: Placebo oral capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT00390013
IRB 20060674
RR00059 (Other Identifier)
200606748 (Other Identifier)

Details and patient eligibility

About

The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.

Full description

There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that is not usually painful, stimuli that would not usually be painful causing significant pain, and burning pain. Gabapentin has been shown to be effective in treating chronic pain.

Enrollment

9 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All women, ages 18 years and older with the diagnosis of vulvodynia or VVS (by Friedrich's criteria), who present to the University of Iowa Vulvar Vaginal Disease Clinic.

Exclusion criteria

  • Vulvar Vaginal Disease clinic patients who are pregnant, less than 3 months postpartum, breast-feeding, non-English speaking, or have contraindication to use of gabapentin due to allergy or renal disease (serum creatinine level greater than 1.4).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

9 participants in 2 patient groups, including a placebo group

Gabapentin
Active Comparator group
Description:
Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Treatment:
Drug: Gabapentin
Placebo oral capsule
Placebo Comparator group
Description:
Placebo titration and dosing for total of 8 weeks (Cross over)
Treatment:
Drug: Placebo oral capsule

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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