A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- vaginal swab
研究概览
简要总结
The aim of the study is to investigate the efficacy of Fluconazol versus L-Mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. Vaginal swabs will be analyzed after 1, 6 and 12 months. The study ends after 252 included patients completed the study.
详细描述
The purpose of this study is to investigate the vaginal culture (positive or negative) after the application of a Medical Grade Honey formulation (L-Mesitran ®) in relation to the current standard of care (Fluconazole) 1 month after starting treatment in patients with RVCC. As a secondary outcome, the effects on symptoms, including redness, irritation, itching, dysuria, dyspareunia and vaginal discharge will be analyzed. In addition, the vaginal culture after 6 months maintenance application and the number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, and quality of life will be collected and compared. The study ends after 252 included patients completed the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of at least 18 years old
- •Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
- •Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
- •Capacity to understand, consent, and comply with the trial procedures
排除标准
- •Mixed vaginal infections
- •Pregnancy or the intention to become pregnant during the study period
- •Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
- •Known allergies or contra-indications for Fluconazole or honey
- •Candida with resistance for Fluconazole
- •Women giving breastfeeding
研究组 & 干预措施
Fluconazole
Way of administration: oral capsules. One capsule at the same day of the week.
Dosage:
As treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole.
As prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.
干预措施: Fluconazole (Drug)
L-Mesitran
Way of administration: intra-vaginal application using an applicator.
Dosage:
As treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.
干预措施: L-Mesitran (Device)
结局指标
主要结局
vaginal swab
时间窗: 12 months
The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).
次要结局
- Side effects of medication will be determined with questionnaires(12 months)
- Quality of life will be determined with questionnaires(12 months)