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5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

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ClinicalTrials.gov Identifier: NCT00450242
Recruitment Status : Terminated (lack of funding)
First Posted : March 22, 2007
Results First Posted : July 16, 2012
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Vulvar Vestibulitis
Interventions Drug: 5% topical lidocaine ointment
Drug: Placebo cream
Enrollment 14
Recruitment Details A total of 14 subjects were recruited via advertisement and clinical referrals from within the medical center and from the community of referring physicians.
Pre-assignment Details  
Arm/Group Title 5% Lidocaine Cream Placebo Cream
Hide Arm/Group Description 5% topical lidocaine cream. [Not Specified]
Period Title: Overall Study
Started 7 7
Completed 4 6
Not Completed 3 1
Arm/Group Title 5% Lidocaine Cream Placebo Cream Total
Hide Arm/Group Description 5% topical lidocaine cream. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
7
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
30.9  (8.5) 29.4  (5.7) 29.9  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
7
 100.0%
7
 100.0%
14
 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 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Number of Participants Who Report the Ability to Have Intercourse
Hide Description Participants' response upon inquiry.
Time Frame baseline, week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Three lidocaine subjects and one control subject failed to complete the study.
Arm/Group Title 5% Lidocaine Cream Placebo Cream
Hide Arm/Group Description:
5% topical lidocaine cream.
Topical cream vehicle.
Overall Number of Participants Analyzed 4 6
Measure Type: Number
Unit of Measure: participants
4 6
2.Primary Outcome
Title Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8
Hide Description 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.
Time Frame baseline, week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
three lidocaine subjects and one control subject failed to complete the study.
Arm/Group Title 5% Lidocaine Cream Placebo Cream
Hide Arm/Group Description:
5% topical lidocaine cream.
[Not Specified]
Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.5  (10.3) 19.7  (24.3)
3.Secondary Outcome
Title SF-12 Quality of Life Scores
Hide Description 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.
Time Frame baseline, week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5% Lidocaine Cream Placebo Cream
Hide Arm/Group Description:
5% topical lidocaine cream.
topical cream vehicle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Modified Gracely Pain Scale
Hide Description 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).
Time Frame baseline, week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5% Lidocaine Cream Placebo Cream
Hide Arm/Group Description:
5% topical lidocaine cream.
Topical cream vehicle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5% Lidocaine Cream Placebo Cream
Hide Arm/Group Description 5% topical lidocaine cream. [Not Specified]
All-Cause Mortality
5% Lidocaine Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
5% Lidocaine Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
5% Lidocaine Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/6 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Denniz Zolnoun, MD, MPH
Organization: University of North Carolina, Dept. of Obstetrics and Gynecology
Phone: 919-966-7764
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00450242     History of Changes
Other Study ID Numbers: 05-2332
First Submitted: March 21, 2007
First Posted: March 22, 2007
Results First Submitted: February 27, 2012
Results First Posted: July 16, 2012
Last Update Posted: July 16, 2012