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Pregabalin for the Treatment of Vulvodynia

Information source: The Cleveland Clinic
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vulvodynia; Vulvar Vestibulitis

Intervention: pregabalin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: The Cleveland Clinic

Official(s) and/or principal investigator(s):
Beri M Ridgeway, MD, Principal Investigator, Affiliation: The Cleveland Clinic
Matthew D Barber, MD, MHS, Study Director, Affiliation: The Cleveland Clinic

Overall contact:
Research Line, Phone: 216-445-8090, Email: riche@ccf.org

Summary

The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.

Clinical Details

Official title: Pregabalin (Lyrica) for the Treatment of Vulvodynia: A Randomized, Double-blinded, Placebo-controlled Cross-over Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction in average pain over the last 7 days of each arm using an 11-point scale (0-10)

Secondary outcome:

Effect on quality of life as measured by the Brief Pain Inventory, the Medical Outcomes Study Short-form 36 (SF-36)

Effect on sleep based on MOS sleep scores

Tolerability of pregabalin in this population

Effect on anxiety and depression in women with vulvodynia based on the Kessler Psychological Distress Scale (K10)

Detailed description: Vulvodynia is a condition exclusive to women and involves mostly burning, rawness, and itching of the external genitourinary tract that often results in painful intercourse. Vulvodynia rarely results in severe morbidity or mortality; rather it causes symptoms of the lower genital, urinary, and gastrointestinal tracts that can impact a woman's daily activities and negatively affect her quality of life.

Despite the fact that chronic vulvovaginal symptoms are one of the most common reasons for visits to a gynecology clinic, epidemiologic studies of the incidence and prevalence of these conditions are rare and available population-based studies are limited. Approximately 16% of women will experience chronic vulvar pain at some point in their lifetime; with 5% experiencing this condition before age 25.

Treatment approaches include behavioral changes, medical management, and surgery, specifically vulvar vestibulectomy. Prior to considering surgical intervention, all medical treatment options should be exhausted. Although vulvodynia is quite prevalent and can be a debilitating disease, there are few studies that critically evaluate the medical management of vulvodynia. Pregabalin is an anticonvulsant that has proven efficacy in the treatment of diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia. Anecdotal data and one case report provide hope that this medication may also be effective in the treatment of vulvodynia.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Adult women age 18 or greater

- Vulvodynia as defined as chronic vulvar discomfort or pain, characterized by burning,

stinging, irritation or rawness of the female genitalia in cases in which there is no infection or skin disease of the vulva or vagina causing these symptoms. Pain may be constant or intermittent, localized or diffuse. Symptoms may be consistent with either Generalized Vulvodynia (diffuse or focal and constant or unremitting symptoms present in the labia majora, labia minora, and/or the vestibule that are not necessarily caused by touch or pressure to the vulva) or Vulvar Vestibulitis Syndrome (pain only in the vestibule and only during or after touch or pressure is applied).

- Pain ≥ 40 on 100mm VAS

- Practicing reliable form of birth control defined as sterilization, hormonal

contraception, abstinence, IUD

- Must be able to attend follow up visits and are not likely to leave the area during

the study period

Exclusion Criteria:

- Atrophic vaginitis, active bacterial vaginosis, yeast, and herpetic infections

- Current pregnancy diagnosed by positive serum or urine pregnancy test

- Current breastfeeding

- Seizure disorder or other chronic neurologic disease

- Diagnosis of chronic renal insufficiency defined as creatinine >1. 4

- Unable to read and speak English

- Contraindication to pregabalin or history of prior use of pregablin

- Chronic narcotic or benzodiazepine use

- Chronic alcohol abuse

- Other chronic pain disorders, (ie. chronic pelvic pain, endometriosis, interstitial

cystitis)

- Chronic neuropathic pain or anything affecting sensation (ie. MS, stroke)

Locations and Contacts

Research Line, Phone: 216-445-8090, Email: riche@ccf.org

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Research Line, Phone: 216-445-8090, Email: riche@ccf.org
Beri M Ridgeway, MD, Phone: 216-445-6586, Email: ridgewb@ccf.org
Additional Information

Starting date: February 2009
Last updated: June 15, 2010

Page last updated: December 08, 2011

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