Pregabalin for the Treatment of Vulvodynia

June 22, 2021 updated by: The Cleveland Clinic

Pregabalin (Lyrica) for the Treatment of Vulvodynia: A Randomized, Double-blinded, Placebo-controlled Cross-over Study

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Lyrica
Experimental: placebo/pregabalin
placebo and pregabalin given using a cross-over design
Drug: pregabalin
pregabalin 150mg twice daily for 4 weeks
Other Names:
  • Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Beri M Ridgeway, MD, The Cleveland Clinic
  • Study Director: Matthew D Barber, MD, MHS, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 2, 2009

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCF 08-195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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