Status:
TERMINATED
Pregabalin for the Treatment of Vulvodynia
Lead Sponsor:
The Cleveland Clinic
Conditions:
Vulvodynia
Vulvar Vestibulitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00853229
Start Date
February 1 2009
End Date
April 1 2013
Last Update
July 19 2021
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195