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Pregabalin for the Treatment of Vulvodynia

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ClinicalTrials.gov Identifier: NCT00853229
Recruitment Status : Terminated (Not feasible due to low accrual)
First Posted : March 2, 2009
Results First Posted : May 15, 2017
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief Summary:
The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.

Condition or disease Intervention/treatment Phase
Vulvodynia Vulvar Vestibulitis Drug: pregabalin Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10) [ Time Frame: 4 weeks ]

    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.



Secondary Outcome Measures :
  1. Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10) [ Time Frame: 4 weeks ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853229


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Beri M Ridgeway, MD The Cleveland Clinic
Study Director: Matthew D Barber, MD, MHS The Cleveland Clinic
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00853229    
Other Study ID Numbers: CCF 08-195
First Posted: March 2, 2009    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: July 19, 2021
Last Verified: June 2021
Keywords provided by The Cleveland Clinic:
vulvodynia
vulvar vestibulitis
chronic vulvar pain
generalized vulvodynia
localized vulvodynia
Additional relevant MeSH terms:
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Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Vulvitis
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs