ISRCTN77890633已完成不适用
A randomized, comparative, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of a 250 mg Vitamin C vaginal tablet - as prophylaxis of recurrent bacterial vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Age = 18 years and < 50 years
- •2. Medical history positive for recurrent BV episodes (= 2 by years)
- •3. Regular menses
- •4. Diagnosis of BV (= 3 out of 4 Amsel criteria) at enrolment
- •5. Cure from the current BV episode (= 3 out of 4 Amsel criteria) with either metronidazole or clindamycin, according to the local therapeutic protocols
- •6. Written informed consent
- •7. Co-operative and reliable women
排除标准
- •1. Subjects with known hypersensitivity to ascorbic acid or to any of the ingredients
- •2. Metrorrhagia, polymenorrhea, amenorrea
- •3. Current or previous infections due to Neisseria gonorrheae, Treponema palidum, Herpes genitalis during the last 2 weeks before enrolment
- •4. Current or previous infections due to Candida spp. or to Trichomonas vaginalis during the last 2 weeks before enrolment
- •5. Concomitant treatment with local antibiotics, such as metronidazole and clindamycin, during the study prophylaxis
- •6. Concomitant use of local acidifying agents, disinfectants, Lactobacillus preparations or vaginal douching during the last 2 weeks before enrolment and during the study period
- •7. Immunodepression, including HIV positive patients
- •8. Concomitant neoplastic diseases under treatment
- •9. Ongoing pregnancy of women willing to be pregnant during the study period
- •10. Participation to clinical trials with investigational drug / devices during the last 3 months before enrolment
- •11. History of alcohol and drug abuse
- •12. Subjects likely to be not compliant or uncooperative
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