Trial Outcomes & Findings for 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis (NCT NCT00450242)

Results Overview

Participants' response upon inquiry.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

baseline, week 8

Results posted on

2012-07-16

Participant Flow

A total of 14 subjects were recruited via advertisement and clinical referrals from within the medical center and from the community of referring physicians.

Participant milestones

Participant milestones
Measure	5% Lidocaine Cream 5% topical lidocaine cream.	Placebo Cream
Overall Study STARTED	7	7
Overall Study COMPLETED	4	6
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5% Lidocaine Cream n=7 Participants 5% topical lidocaine cream.	Placebo Cream n=7 Participants	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	30.9 years STANDARD_DEVIATION 8.5 • n=93 Participants	29.4 years STANDARD_DEVIATION 5.7 • n=4 Participants	29.9 years STANDARD_DEVIATION 7.0 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	7 participants n=93 Participants	7 participants n=4 Participants	14 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline, week 8

Population: Three lidocaine subjects and one control subject failed to complete the study.

Participants' response upon inquiry.

Outcome measures

Outcome measures
Measure	5% Lidocaine Cream n=4 Participants 5% topical lidocaine cream.	Placebo Cream n=6 Participants Topical cream vehicle.
Number of Participants Who Report the Ability to Have Intercourse	4 participants	6 participants

PRIMARY outcome

Timeframe: baseline, week 8

Population: three lidocaine subjects and one control subject failed to complete the study.

Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The "mean" listed for each group is average week 8 score subtracted from the average baseline score.

Outcome measures

Outcome measures
Measure	5% Lidocaine Cream n=4 Participants 5% topical lidocaine cream.	Placebo Cream n=6 Participants Topical cream vehicle.
Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8	2.5 units on a scale Standard Deviation 10.3	19.7 units on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: baseline, week 8

Population: The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.

The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, week 8

Population: The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.

The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8).

Outcome measures

Outcome data not reported

Adverse Events

5% Lidocaine Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Cream

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

Denniz Zolnoun, MD, MPH

University of North Carolina, Dept. of Obstetrics and Gynecology

Phone: 919-966-7764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place