Pregabalin for the Treatment of Vulvodynia

Study Overview
=================
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.

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

Conditions
-----------------
Vulvodynia, Vulvar Vestibulitis

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pregabalin/placebo<br>pregabalin and placebo given using a cross-over design | Drug: pregabalin<br>* pregabalin 150mg twice daily for 4 weeks<br>* Other names: Lyrica;|
| Experimental: placebo/pregabalin<br>placebo and pregabalin given using a cross-over design | Drug: pregabalin<br>* pregabalin 150mg twice daily for 4 weeks<br>* Other names: Lyrica;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10) | The primary objective of this protocol is to compare the reduction in pain using an 11-point scale (0-10) at four weeks of treatment. A responder will be defined as a subject noting a ≥50% reduction in pain using this scale. The NRS is an 11-point scale comprising a number from 0 through 10; 0 indicates no pain, and 10 indicates the worst imaginable pain. Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10) | Subjects will complete the Kessler Psychological Distress Scale (K10). It is a measure of psychological distress. Scores will range from 10 to 50, with the higher the score, the higher the mental distress Data not measured due to early discontinuation of the study prior to the designated follow up time frame. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vulvodynia, vulvar vestibulitis, chronic vulvar pain, generalized vulvodynia, localized vulvodynia