Study of the efficacy and safety of treatment with total freeze-dried culture of Lcr Regenerans® administered intravaginally in the prevention of recurrent vulvovaginal candidiasis.International, randomized, phase III, multi-centre, 2-arm, parallel group, double-blind, placebo-controlled superiority trial. - Study of the efficacy and safety of Lcr Regenerans®_GynoCans.

BIOSE0 个研究点目标入组 234 人开始时间: 2014年7月30日最近更新: 2018年8月20日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 234

研究概览入排标准研究者记录与标识符相似试验

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

•Disease-related criteria:
•- Patients with recurrent vulvo-vginal candidiasis, defined by the existence of at least 4 episodes of VVC during the previous year including the episode which was the subject of the screening visit
•In addition to the current episode, at least one episode that occurred in the previous two years should also be documented by mycological examination.)
•- Patients with acute vulvovaginitis characterised by the presence of the following clinical criteria (i at V1: symptoms of pruritus, vulvovaginal signs such as erythema, vaginal discharge
•- Patients with a positive mycological examination at V1
•- Patients who are clinically cured at the end of Day 8 after treatment with MONAZOL Ovule (one ovule at bedtime) and so just after treatment with MONAZOL cream (treatment lasting 8 days).
•Relating to the population:
•- Women of childbearing age:
•Urinary pregnancy test negative
•Use of a contraceptive method considered effective by the investigator (except spermicides) throughout the test
•- Patient / legal representative speak and read the local language and having been informed of the study and has voluntarily signed an Informed Consent Form
•- Patient / legal representative affiliated with a social insurance scheme
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 6
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 228
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Relating to the disease or gynaecological issues:
•- Presence of an infection, bacterial or viral, assumed or demonstrated to be gynaecological, whether treated or not in the month prior to inclusion or present at inclusion.
•- Presence of an existing gynaecological infection that may interfere with the assessment of the trial treatment (severe dysplasia of the cervix or in situ carcinoma, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
•- Patients with a negative mycological examination at V1
•- No adequate documentation of earlier episodes to confirm the recurrent character of the VVC (4 episodes in one year, two of which documented a mycological examination in the past two years [and, in addition to the current episode, at least one episode occurred in the previous two years should also be documented in a mycological examination])
•Relating to treatment:
•- Taking systemic antifungals (particularly Fluconazole, see the list in 17.2) in the month prior to the screening visit to prevent recurrence, (treatment of an acute episode of VVC is not an exclusion criterion).
•- Use of probiotics (see the list in 17.2) in the 3 months preceding the screening visit.
•- Use of prebiotics (acidifying) (see the list in 17.2) in the 15 days preceding the screening visit.
•- Allergy to one of the active substances or one of the excipients in the products.
•Relating to the population:
•- Patients unable to comply with the constraints of the protocol.
•- Breastfeeding women.
•- Patients with bleeds for more than 12 days per month.
•- Patients who have taken part in a clinical study in the last month preceding inclusion in the present protocol.
•- Patients with severe disease, whether acute or chronic, deemed by the investigator to be incompatible with participation in the trial or a serious condition which is life-threatening in the short term.
•- Immunocompromised patients.
•- Patients with a previous illness which, according to the investigator, may interfere with the results of the study or expose the patient to an additional risk.
•- Patients linguistically (unable to speak or write French) or mentally unable to understand and sign the Informed Consent Form.
•- Patients deprived of their liberty by administrative or legal decision or under guardianship.
•- Patients who may not comply with treatment.
•- Patients unable to be contacted in the case of an emergency.

研究者

发起方

BIOSE

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