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Pregabalin for the Treatment of Vulvodynia

TerminatedPhase 2NCT00853229
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Pregabalin (Lyrica) for the Treatment of Vulvodynia: A Randomized, Double-blinded, Placebo-controlled Cross-over Study
Conditions
  • Vulvodynia
  • Vulvar Vestibulitis
Interventions
Sponsor
The Cleveland Clinic
Start date
2009-02
Primary completion
2013-04
Sex
Female
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00853229