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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
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
5% Lidocaine Cream 5% topical lidocaine cream.
Placebo Cream No text entered.

Participant Flow:   Overall Study
    5% Lidocaine Cream   Placebo Cream
STARTED   7   7 
COMPLETED   4   6 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
5% Lidocaine Cream 5% topical lidocaine cream.
Placebo Cream No text entered.
Total Total of all reporting groups

Baseline Measures
   5% Lidocaine Cream   Placebo Cream   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   7   7   14 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 30.9  (8.5)   29.4  (5.7)   29.9  (7.0) 
[Units: Participants]
Female   7   7   14 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   7   7   14 

  Outcome Measures

1.  Primary:   Number of Participants Who Report the Ability to Have Intercourse   [ Time Frame: baseline, week 8 ]

2.  Primary:   Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8   [ Time Frame: baseline, week 8 ]

3.  Secondary:   SF-12 Quality of Life Scores   [ Time Frame: baseline, week 8 ]

4.  Secondary:   Modified Gracely Pain Scale   [ Time Frame: baseline, week 8 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

  More Information

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
e-mail: denniz_zolnoun@med.unc.edu

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