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Pregabalin for the Treatment of Vulvodynia

This study has been terminated.
(Not feasible due to low accrual)
Information provided by (Responsible Party):
The Cleveland Clinic Identifier:
First received: February 27, 2009
Last updated: April 6, 2017
Last verified: April 2017
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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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:

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 ]
    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.

Secondary Outcome Measures:
  • Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10) [ Time Frame: 4 weeks ]
    Data not measured due to early discontinuation of the study prior to the designated follow up time frame.

Enrollment: 16
Study Start Date: February 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00853229

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

Responsible Party: The Cleveland Clinic Identifier: NCT00853229     History of Changes
Other Study ID Numbers: CCF 08-195
Study First Received: February 27, 2009
Results First Received: January 10, 2017
Last Updated: April 6, 2017

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

Additional relevant MeSH terms:
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on September 19, 2017