To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

NCT00390013 | Terminated Results DMC

• 3 other identifiers: IRB 20060674RR00059200606748
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vulvar Pain Symptoms; Vulvodynia (Chronic Vulvar Pain)

Keywords

Vulvar Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)

Drug: Gabapentin

Placebo oral capsule

PLACEBO COMPARATOR

Placebo titration and dosing for total of 8 weeks (Cross over)

Drug: Placebo oral capsule

Interventions

Gabapentin DRUG

300 mg. capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13: 1. day 1 you will take 1 capsule for the day 2. day 2 you will take 1 capsule 2 times for that day 3. days 3-6 you will take 1 capsule 3 times for those days 4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day 5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day 6. days 13-14 you will take 2 capsules 3 times each day 7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13. 8. at completion of study treatment you will titrate off study drug over a weeks time.

Also known as: Neurontin

Gabapentin

Placebo oral capsule DRUG

Placebo capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13: 1. day 1 you will take 1 capsule for the day 2. day 2 you will take 1 capsule 2 times for that day 3. days 3-6 you will take 1 capsule 3 times for those days 4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day 5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day 6. days 13-14 you will take 2 capsules 3 times each day 7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13. 8. at completion of study treatment you will titrate off study drug over a weeks time.

Also known as: Placebo

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Colleen Stockdale: lead

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Vulvodynia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Lack of enrollment leading to early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Colleen Kennedy Stockdale, MD, MS
• Organization: University of Iowa

colleen-stockdale@uiowa.edu

319-384-6849

Study Officials

• Colleen Kennedy Stockdale, M.D., M.S.

  University of Iowa Hospital and Clinics, Department of Ob/Gyn

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: January 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)