EUCTR2018-003095-12-BG进行中（未招募）1 期
An investigator-blinded, active controlled, randomized, twoparallel group, multi-dose clinical trial to prove the non-inferiorefficacy of Lactobacillus plantarum P 17630 100.000.000 CFUsoft vaginal capsules (Proge Farm s.r.l.) versus miconazolenitrate 400 mg vaginal soft capsules in vaginal candidiasis.
PROGE FARM SR0 个研究点目标入组 210 人开始时间: 2019年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Pre-menopausal women of any race and
- •between 18 to 45 years of age;
- •? Diagnosis of VVC based on the presence of the
- •following four criteria: pruritus, discharge, pain,
- •? Negative results on the Bayer evaluating kit
- •(Gyno-Canestest®);
- •? Negative pregnancy test
- •? Willing to refrain from using any vaginal product
- •(e.g. spermicide, tampon, douche, diaphragm or
- •condom), other than study product, on study
- •? Willing to refrain from sexual intercourse on study
- •? Able to understand the requirements of the
- •clinical trial and to agree to return for the required
- •follow-up visits;
- •? Willing to provide voluntary written informed
- •consent and data protection declaration before
- •any clinical trail related procedure is performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Menstruating when diagnosis of vulvovaginal
- •candidiasis is determined at Baseline visit;
- •? Primary or secondary immunodeficiency;
- •? Severe liver disease;
- •? History of regional enteritis or ulcerative colitis;
- •? Current or past evidence of any vulvovaginitis
- •other than bacterial vaginosis (e.g. candidiasis,
- •Trichomonas vaginalis, Chlamydia trachomatis,
- •Neisseria gonorrhoeae, Herpes simplex or
- •human papilloma virus) in the previous 4 months;
- •? Subject will be under treatment during the study
- •period for cervical intraepithelial neoplasia or
- •cervical carcinoma;
- •? History of hypersensitivity to miconazole nitrate,
- •Lactobacillus plantarum or any of the
- •components of the formulation;
- •? Use within 2 weeks prior to baseline of topical or
- •systemic antibiotics/antifungal;
- •? Use of spermicides, tampons, douches,
- •diaphragms, condoms or other intra-vaginal
- •product within 48 hours prior to dosing on study
- •? Current participation or not yet completed period
- •of at least 30 days since ending other
- •investigational device or drug trial(s). Use of any
- •experimental medicinal product within the 3
- •months prior to screening.
- •? Unwillingness or inability to comply with the
- •clinical trial procedures;
- •? Who are legally incapacitated;
- •? Who are legally detained in an official institute.
研究者
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