Back to results

Pregabalin for the Treatment of Vulvodynia

Primary Purpose

Vulvodynia, Vulvar Vestibulitis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

pregabalin

About this trial

This is an interventional treatment trial for Vulvodynia focused on measuring vulvodynia, vulvar vestibulitis, chronic vulvar pain, generalized vulvodynia, localized vulvodynia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

pregabalin/placebo

placebo/pregabalin

Arm Description

pregabalin and placebo given using a cross-over design

placebo and pregabalin given using a cross-over design

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00853229

First Posted

February 27, 2009

Last Updated

June 22, 2021

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00853229

Brief Title

Pregabalin for the Treatment of Vulvodynia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

Not feasible due to low accrual

Study Start Date

February 2009 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvodynia, Vulvar Vestibulitis

Keywords

vulvodynia, vulvar vestibulitis, chronic vulvar pain, generalized vulvodynia, localized vulvodynia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pregabalin/placebo

Arm Type

Experimental

Arm Description

pregabalin and placebo given using a cross-over design

Arm Title

placebo/pregabalin

Arm Type

Experimental

Arm Description

placebo and pregabalin given using a cross-over design

Intervention Type

Drug

Intervention Name(s)

pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

pregabalin 150mg twice daily for 4 weeks

Primary Outcome Measure Information:

Title

Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)

Description

Time Frame

4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beri M Ridgeway, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Matthew D Barber, MD, MHS

Organizational Affiliation

The Cleveland Clinic

Official's Role

Study Director

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pregabalin for the Treatment of Vulvodynia

We'll reach out to this number within 24 hrs