Pregabalin for the Treatment of Vulvodynia

Brief Title

Pregabalin for the Treatment of Vulvodynia

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


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 Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)

Condition

Vulvodynia

Intervention

pregabalin

Study Arms / Comparison Groups

 pregabalin/placebo
Description:  pregabalin and placebo given using a cross-over design

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

16

Start Date

February 2009

Completion Date

April 2013

Primary Completion Date

April 2013

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)
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Beri M Ridgeway, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00853229

Organization ID

CCF 08-195


Responsible Party

Sponsor

Study Sponsor

The Cleveland Clinic


Study Sponsor

Beri M Ridgeway, MD, Principal Investigator, The Cleveland Clinic


Verification Date

April 2017