Pregabalin for the Treatment of Vulvodynia

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00853229
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 49.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

• Study Type: Interventional
• 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: Feb 1, 2009
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00853229
• Other Study ID Numbers: CCF 08-195
• First Posted: Mar 2, 2009
• Last Update Posted: Jul 19, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by The Cleveland Clinic: vulvodynia; vulvar vestibulitis; chronic vulvar pain; generalized vulvodynia; localized vulvodynia
• Additional relevant MeSH terms: Vulvodynia; Vulvar Vestibulitis; Pregabalin

Study Results

Participant Flow

Arm/Group Title	Pregabalin First 4 Weeks	Placebo First 4 Weeks
Arm/Group Description	pregabalin and placebo given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	placebo and pregabalin given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks
Period Title: Phase 1: Initial Intervention
STARTED	8	8
COMPLETED	0	0
NOT COMPLETED	8	8
Period Title: Phase 1: Initial Intervention
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pregabalin First 4 Weeks	Placebo First 4 Weeks	Total
Arm/Group Description	pregabalin and placebo given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	placebo and pregabalin given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	Total of all reporting groups
Overall Participants	8	8	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.0 (8.9)	36.3 (13.1)	35.6 (11.0)
Sex: Female, Male (Count of Participants)
Female	8 100%	8 100%	16 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	8 100%	8 100%	16 100%

Outcome Measures

1. Primary Outcome

Title	Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pregabalin/Placebo	Placebo/Pregabalin
Arm/Group Description	pregabalin and placebo given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	placebo and pregabalin given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks
Measure Participants	0	0

2. Secondary Outcome

Title	Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Data not measured due to early discontinuation of the study prior to the designated follow up time frame.

Arm/Group Title	Pregabalin First 4 Weeks	Placebo First 4 Weeks
Arm/Group Description	pregabalin and placebo given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	placebo and pregabalin given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks
Measure Participants	0	0

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	Data not collected. Long term follow up not available for adverse events as study was discontinued early.
Arm/Group Title	Pregabalin/Placebo		Placebo/Pregabalin
Arm/Group Description	pregabalin and placebo given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks		placebo and pregabalin given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks
All Cause Mortality
	Pregabalin/Placebo		Placebo/Pregabalin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pregabalin/Placebo		Placebo/Pregabalin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Pregabalin/Placebo		Placebo/Pregabalin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.