Pregabalin for the Treatment of Vulvodynia

• ClinicalTrials.gov Identifier: NCT00853229
• Recruitment Status: Terminated
• First Posted: March 2, 2009
• Results First Posted: May 15, 2017
• Last Update Posted: July 19, 2021
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Vulvodynia; Vulvar Vestibulitis
• Intervention: Drug: pregabalin
• Enrollment: 16

Participant Flow

Recruitment Details
Pre-assignment Details

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
Reason Not Completed
Early study termination, poor enrollment	8	8
Period Title: Phase 2: Cross Over
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 Number of Baseline Participants		8	8	16
Baseline Analysis Population Description		No study analysis completed due to early termination due to poor enrollment
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	8 participants	8 participants	16 participants
		35.0 (8.9)	36.3 (13.1)	35.6 (11.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants	8 participants	16 participants
	Female	8 100.0%	8 100.0%	16 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	8 participants	8 participants	16 participants
		8	8	16

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
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

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 (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Pregabalin/Placebo	Placebo/Pregabalin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/8 (0.00%)	0/8 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Pregabalin/Placebo	Placebo/Pregabalin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/8 (0.00%)	0/8 (0.00%)

Limitations and 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.

Results Point of Contact

• Name/Title: Lynn Borzi (Research Administrator)
• Organization: Cleveland Clinic
• Phone: 216-445-3158
• EMail: BORZIL@ccf.org

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00853229
• Other Study ID Numbers: CCF 08-195
• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Results First Submitted: January 10, 2017
• Results First Posted: May 15, 2017
• Last Update Posted: July 19, 2021