Pregabalin for the Treatment of Vulvodynia

• Status: Terminated
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Pregabalin

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)