Topical Application of Nifedipine Cream for the Treatment of Vulvar Vestibulitis Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Complete resolution of vestibulitis.
研究概览
简要总结
To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).
详细描述
30 women aged 18-45 diagnosed with Provoked localized Vulvodynia will be included. 10 women will use topical Nifedipine cream 0.2% 4 times a day for 6 weeks (except for menstrual period). 10 other women will use topical Nifedipine cream 0.4% 4 times a day for 6 weeks (except for menstrual period).
10 women will be a control group and will use a placebo cream. The study will be randomized and double blind. Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment. A special detailed questionnaire has been prepared in three languages and will be used to compare dyspareunia and associate variables between the groups.
The Q-tip tests will be performed and findings will be drawn in each examination. Differences between the groups will be examined, and uni- and multi-variate analysis will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with vestibulitis according to Friedrich's criteria:
- •Severe pain with vestibular touch or attempted vaginal entry.
- •A positive Q-tip test: pain produced by touching the vestibule with a cotton tipped applicator.
- •Physical findings limited to varying degree of vestibular erythema.
- •Non-pregnant women aged 18-
- •Women use effective contraception and are not interested in becoming pregnant during the study period.
- •No known Nifedipine allergy.
- •No medical diseases.
排除标准
- •Women who have undergone vestibulectomy.
- •Active vaginal or pelvic infection.
- •A medical disease uch as Diabetes, immune suppression.
结局指标
主要结局
Complete resolution of vestibulitis.
时间窗: Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire and the Q-tip applicator for detection of vestibular sensitivity.
次要结局
- Safety of the Nifedipine treatment.(Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire.)