NCT00450242终止2 期
Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants Who Report the Ability to Have Intercourse
研究概览
简要总结
- 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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.
排除标准
- •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
研究组 & 干预措施
5% Lidocaine cream
Experimental
5% topical lidocaine cream.
干预措施: 5% topical lidocaine ointment (Drug)
Placebo cream
Placebo Comparator
干预措施: Placebo cream (Drug)
结局指标
主要结局
Number of Participants Who Report the Ability to Have Intercourse
时间窗: baseline, week 8
Participants' response upon inquiry.
Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8
时间窗: 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.
次要结局
- SF-12 Quality of Life Scores(baseline, week 8)
- Modified Gracely Pain Scale(baseline, week 8)
研究者
研究点 (1)
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