Clinical trial NCT00853229: Pregabalin for the Treatment of Vulvodynia
Official title: Pregabalin (Lyrica) for the Treatment of Vulvodynia: A Randomized, Double-blinded, Placebo-controlled Cross-over Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vulvodynia
Vulvar Vestibulitis
Keywords: vulvodynia
vulvar vestibulitis
chronic vulvar pain
generalized vulvodynia
localized vulvodynia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-03-02
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)
timeFrame: 4 weeks
Secondary outcomes:
measure: Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Beri M Ridgeway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Matthew D Barber, MD, MHS
role: STUDY_DIRECTOR
References: