To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

Vulvar Pain Symptoms Clinical Trial

Official title:

Vulvar Pain: Treatment Trial Using Gabapentin-placebo in a Cross-over Design, Pilot Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00390013
• Other study ID #: IRB 20060674
• Secondary ID: RR00059200606748
• Status: Terminated
• Phase: N/A
• First received: October 18, 2006
• Last updated: July 28, 2017
• Start date: January 2007
• Est. completion date: March 2008

Study information

• Verified date: July 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Vulvar Pain Symptoms
• Vulvodynia
• Vulvodynia (Chronic Vulvar Pain)

Intervention

Drug:
• Gabapentin
300 mg. capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13: day 1 you will take 1 capsule for the day day 2 you will take 1 capsule 2 times for that day days 3-6 you will take 1 capsule 3 times for those days days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day days 13-14 you will take 2 capsules 3 times each day continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13. at completion of study treatment you will titrate off study drug over a weeks time.
• Placebo oral capsule
Placebo capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13: day 1 you will take 1 capsule for the day day 2 you will take 1 capsule 2 times for that day days 3-6 you will take 1 capsule 3 times for those days days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day days 13-14 you will take 2 capsules 3 times each day continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13. at completion of study treatment you will titrate off study drug over a weeks time.

Locations

Country	Name	City	State
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Colleen Stockdale

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Vulvar Pain	change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain.	19 weeks