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Pregabalin for the Treatment of Vulvodynia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00853229
First received: February 27, 2009
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Vulvodynia
Vulvar Vestibulitis
 Drug: pregabalin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregabalin (Lyrica) for the Treatment of Vulvodynia: A Randomized, Double-blinded, Placebo-controlled Cross-over Study

Resource links provided by NLM:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Reduction in average pain over the last 7 days of each arm using an 11-point scale (0-10) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on quality of life as measured by the Brief Pain Inventory, the Medical Outcomes Study Short-form 36 (SF-36) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Effect on sleep based on MOS sleep scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Tolerability of pregabalin in this population [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Effect on anxiety and depression in women with vulvodynia based on the Kessler Psychological Distress Scale (K10) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pregabalin/placebo
pregabalin and placebo given using a cross-over design
 Drug: pregabalin
pregabalin 150mg twice daily for 4 weeks
Other Name: Lyrica
Experimental: placebo/pregabalin
placebo and pregabalin given using a cross-over design
 Drug: pregabalin
pregabalin 150mg twice daily for 4 weeks
Other Name: Lyrica

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853229

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Beri M Ridgeway, MD The Cleveland Clinic
Study Director: Matthew D Barber, MD, MHS The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00853229     History of Changes
Other Study ID Numbers: CCF 08-195
Study First Received: February 27, 2009
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
vulvodynia
vulvar vestibulitis
chronic vulvar pain
generalized vulvodynia
localized vulvodynia

Additional relevant MeSH terms:
Vulvar Vestibulitis
Vulvodynia
Vulvitis
Vulvar Diseases
Genital Diseases, Female
Pregabalin
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 21, 2013