Trial Outcomes & Findings for Pregabalin for the Treatment of Vulvodynia (NCT NCT00853229)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Pregabalin First 4 Weeks pregabalin and placebo given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	Placebo First 4 Weeks placebo and pregabalin given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks
Phase 1: Initial Intervention STARTED	8	8
Phase 1: Initial Intervention COMPLETED	0	0
Phase 1: Initial Intervention NOT COMPLETED	8	8
Phase 2: Cross Over STARTED	0	0
Phase 2: Cross Over COMPLETED	0	0
Phase 2: Cross Over NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin First 4 Weeks pregabalin and placebo given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	Placebo First 4 Weeks placebo and pregabalin given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks
Phase 1: Initial Intervention Early study termination, poor enrollment	8	8

Baseline Characteristics

Pregabalin for the Treatment of Vulvodynia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin First 4 Weeks n=8 Participants pregabalin and placebo given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	Placebo First 4 Weeks n=8 Participants placebo and pregabalin given using a cross-over design pregabalin: pregabalin 150mg twice daily for 4 weeks	Total n=16 Participants Total of all reporting groups
Age, Continuous	35.0 years STANDARD_DEVIATION 8.9 • n=5 Participants	36.3 years STANDARD_DEVIATION 13.1 • n=7 Participants	35.6 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Outcome data not reported

Adverse Events

Pregabalin/Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/Pregabalin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lynn Borzi (Research Administrator)

Cleveland Clinic

Phone: 216-445-3158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place