Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450242
Status:
TERMINATED
Last Update Posted:
2012-07-16
First Post:
2007-03-21
Brief Title:
5 Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Use of 5 Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 armThe 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None