EUCTR2015-001472-22-SK进行中（未招募）1 期
A Prospective, Randomized, Double-Blind, Placebo-controlled, Multicenter, Phase III Study Assessing Efficacy and Safety of the IMUNOR® Therapy Versus Placebo in Patients with Recurrent Vulvovaginitis Episodes - IMUNOR-201501
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 123
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
入选标准
- •1.Females aged 18 - 50 years, without signs of menopause-related estrogen deficiency;
- •2.Suspected secondary immune deficiency based on presence of recurrent, symptomatic mycotic and/or bacterial vulvovaginitis episodes documented by a gynecologist (4 or more episodes during the last 12 months prior randomization, with the exception of mycotic episodes accompanying systemic administration of antibiotics);
- •3.Patients willing and able to sign the informed consent, cooperate and participate on prescribed study visits;
- •4.Stable sexual relationships 12 months prior signature of the informed consent and a prerequisite for maintaining them for the next 12 months;
- •5.Documented use of an effective contraception method, Pearl index = 1.
- •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 123
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects with known hypersensitivity to any ingredient of the study medication;
- •2.Pregnant or breast feeding females;
- •3.Females planning to get pregnant during the course of the next 12 months;
- •4.Known personal history of hypothyreosis (or suspected);
- •5.Known personal history of elevated anti-thyroidal antibodies;
- •6.Known personal history of an autoimmune or malignant disease;
- •7.Known personal history of HIV positivity, tuberculosis or intake of treatment lowering the function(s) of the immune system (e.g. immunosuppresants, chemotherapy), with the exception of treatment of bronchial asthma, or allergies (nasal or inhaled corticosteroids);
- •8.Known personal history of HIV positivity, tuberculosis or intake of treatment lowering the function(s) of the immune system (e.g. immunosuppresants, chemotherapy), with the exception of treatment of bronchial asthma, or allergies (nasal or inhaled corticosteroids);
- •9.Acute vulvovaginitis with presence of herpetic viruses or gonorrhea;
- •10.Evidence of chlamydia, trichomonads or an other sexually transmitted disease within 30 days prior the first study visit;
- •11.Use of immune modulation therapy (transfer factor, bacterial lysates, systemic enzymatic therapy, immunoglobulins) during the last 12 months prior the first study visit, or planned initiation of such treatment during the course of the study;
- •12.Use of vaginal probiotics, or antibiotics completed less than 30 days prior the first study visit;
- •13.Participation in another clinical trial within 30 days prior the first study visit;
- •14.Any clinically significant condition or disease, which in the opinion of the investigator, could affect safety of the patient or evaluation of this Study.
研究者
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