5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00450242
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

• Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo.

• This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.

Condition or Disease	Intervention/Treatment	Phase
Vulvar Vestibulitis	Drug: 5% topical lidocaine ointment; Drug: Placebo cream	Phase 2

Detailed Description

• After consent is obtained patients will undergo the following treatment plan: randomization to treatment with 5% lidocaine ointment or placebo for vestibulitis. There will be 56 women total (28 in each arm).The placebo used will be hydrophilic petrolatum. Randomization will be performed using computer generated permuted blocks. A standard history and physical exam incorporating assessment of skin allodynia (testing with q-tip swab) on the vestibule and pressure measurements of the pelvic floor muscles (how much tenderness there is on perineal muscles with palpation) will be performed. Baseline questionnaires that will evaluate sexual frequency, sexual function survey (Female sexual function index), the modified Gracely pain scale of intercourse related pain, and psychometric evaluation including evaluation of anxiety, somatization (State-Trait Anxiety Inventory and Brief Symptom Inventory). Depression can also be evaluated with the Brief Symptom Inventory. Lastly, overall quality of health can be assessed with the SF-12. There is a baseline, 2 week and 6 week visit. Women will abstain from intercourse during these 6 weeks. Women will have a physical exam evaluation of the vestibule at each visit. They will then be able to have intercourse and will repeat surveys of sexual frequency, function, pain scale of intercourse related pain and the SF-12 at 8 weeks.

• Aim 1: To assess if lidocaine ointment produces a superior treatment response to placebo.

• Hypothesis 1: Use of topical lidocaine, compared with placebo, will result in improved sexual function and self-reported pain scores. This is to be measured as the ability to have successful intercourse. Secondarily, sexual function, quality of life and scores for intercourse related pain will be evaluated.

• Aim 2: To assess if there are predictors of response to treatment such as demographics, duration of disease, primary or secondary vulvar vestibulitis, or psychometric assessments (anxiety and somatization).

• Hypothesis 2: There are predictors of response to treatment of vulvar vestibulitis based upon patient characteristics, characteristics of the disease and psychometric assessments.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5% Lidocaine cream 5% topical lidocaine cream.	Drug: 5% topical lidocaine ointment; Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.
Placebo Comparator: Placebo cream	Drug: Placebo cream; hydrophilic petrolatum, dime-sized amount, applied nightly.

Outcome Measures

Primary Outcome Measures

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

   Participants' response upon inquiry.

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

   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.

Secondary Outcome Measures

1. SF-12 Quality of Life Scores [baseline, week 8]

   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.

2. Modified Gracely Pain Scale [baseline, week 8]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.

Exclusion Criteria:

• postmenopausal

• pure vaginismus

• generalized vulvodynia

• pudendal neuralgia

• pregnant, breastfeeding

• less than 2 months post delivery

• diagnosis of dermatologic condition on biopsy

• positive fungal culture

• currently on treatment for vvs

• history of lidocaine treatment for vvs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill

Investigators

• Study Director: Jacqueline Rohl, MD, UNC Division of Advanced Laparoscopy and Pelvic Pain
• Principal Investigator: Denniz Zolnoun, MD MPH, UNC- Division of Advanced Laparoscopy and Pelvic Pain
• Study Chair: John Steege, MD, UNC Division of Advanced Laparoscopy and Pelvic Pain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT00450242
• Other Study ID Numbers: 05-2332
• First Posted: Mar 22, 2007
• Last Update Posted: Jul 16, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by University of North Carolina, Chapel Hill: vulvar vestibulitis; vestibulitis
• Additional relevant MeSH terms: Vulvar Vestibulitis; Lidocaine

Study Results

Participant Flow

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.

Arm/Group Title	5% Lidocaine Cream	Placebo Cream
Arm/Group Description	5% topical lidocaine cream.
Period Title: Overall Study
STARTED	7	7
COMPLETED	4	6
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	5% Lidocaine Cream	Placebo Cream	Total
Arm/Group Description	5% topical lidocaine cream.	Total of all reporting groups
Overall Participants	7	7	14
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	7 100%	14 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.9 (8.5)	29.4 (5.7)	29.9 (7.0)
Sex: Female, Male (Count of Participants)
Female	7 100%	7 100%	14 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	7 100%	14 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Report the Ability to Have Intercourse
Description	Participants' response upon inquiry.
Time Frame	baseline, week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	5% Lidocaine Cream	Placebo Cream
Arm/Group Description	5% topical lidocaine cream.	Topical cream vehicle.
Measure Participants	4	6
Number [participants]	4 57.1%	6 85.7%

2. Primary Outcome

Title	Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	5% Lidocaine Cream	Placebo Cream
Arm/Group Description	5% topical lidocaine cream.
Measure Participants	4	6
Mean (Standard Deviation) [units on a scale]	2.5 (10.3)	19.7 (24.3)

3. Secondary Outcome

Title	SF-12 Quality of Life Scores
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

Outcome Measure Data

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
Arm/Group Description	5% topical lidocaine cream.	topical cream vehicle.
Measure Participants	0	0

4. Secondary Outcome

Title	Modified Gracely Pain Scale
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

Outcome Measure Data

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
Arm/Group Description	5% topical lidocaine cream.	Topical cream vehicle.
Measure Participants	0	0

Adverse Events

Arm/Group Title	5% Lidocaine Cream		Placebo Cream
Arm/Group Description	5% topical lidocaine cream.
All Cause Mortality
	5% Lidocaine Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	5% Lidocaine Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	5% Lidocaine Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/6 (0%)

Limitations/Caveats

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.

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.