Vulvodynia Clinical Trial
Official title:
Pregabalin (Lyrica) for the Treatment of Vulvodynia: A Randomized, Double-blinded, Placebo-controlled Cross-over Study
Verified date | June 2021 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.
Status | Terminated |
Enrollment | 16 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10) | The primary objective of this protocol is to compare the reduction in pain using an 11-point scale (0-10) at four weeks of treatment. A responder will be defined as a subject noting a =50% reduction in pain using this scale.
The NRS is an 11-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain". 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. |
4 weeks | |
Secondary | Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10) | Subjects will complete the Kessler Psychological Distress Scale (K10). It is a measure of psychological distress. Scores will range from 10 to 50, with the higher the score, the higher the mental distress
Data not measured due to early discontinuation of the study prior to the designated follow up time frame. |
4 weeks |
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