EUCTR2014-001759-22-SK进行中（未招募）1 期
Assessment of the efficacy of POLYGYNAX® in the empirical treatment of infectious vaginitisInternational, multicentre, randomised, double-blind, parallel group study, comparative versus miconazole - PRISM
aboratoire Innotech International0 个研究点目标入组 650 人开始时间: 2016年1月15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
- 650
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
- •1. Female outpatients, aged 18 to 64, who have read, understood, signed and dated the informed consent form
- •2. Patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis:
- •bacterial vaginitis
- •non-specific vaginitis (atypical symptoms)
- •mixed vaginitis (i.e. suprainfected fungal vaginitis)
- •and able to receive an empirical local treatment
- •3. Patient for whom follow-up by the investigator for 22 days is possible and able/accepts to comply with the study constraints
- •4. Patient affiliated to a public health insurance coverage
- •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 650
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
- •2. Vaginal infection justifying systemic therapy
- •3. History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
- •4. Patient presenting signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen plannus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))
- •5. Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI (recent history of STI (within 2 months prior to inclusion), infected partner, suggestive symptoms, etc.)
- •6. Patient with underlying debilitating medical conditions
- •7. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)
- •8. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion
- •9. Patient with surgery scheduled during the study
- •10. Allergy or hypersensitivity to one of the components of POLYGYNAX® or to one of the components of comparator treatment (miconazole+placebo)
- •11. Patient menstruating or patient with menometrorraghia due to hormonal imbalance at the time of inclusion
- •12. Patient lactating, or who has delivered within four weeks prior to inclusion
- •13. For patients of childbearing age, patient with a positive urine pregnancy test on the day of the Baseline Visit (Visit 1 / D1)
- •14. Use of spermicide products (associated or not with a diaphragm) within two weeks prior to inclusion
- •15. Patient having used an intra vaginal hormonal treatment (including intravaginal ring) within four weeks prior to inclusion
- •16. For patients of childbearing age, patient not using effective contraception method or using an effective method which needs to be changed or stopped during the study (NB : Use of a latex diaphragm, and/or latex condoms and/or a spermicide is not allowed during the study)
- •17. Patient participating or having participated in a clinical trial within four weeks prior to inclusion
研究者
相似试验
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Study to test the efficacy of POLYGYNAX® in patientspresenting with vaginal infections. POLYGYNAX® is compared tomiconazole followed by a placebo. Miconazole is another active treatment for vaginal infections.Patients presenting with abnormal vaginal discharge associated with other vaginal symptoms (i.e. vaginal burning and/or vaginal irritation and/or vaginal pain) clinically evoking infectious vaginitis (bacterial vaginitis, non specific vaginitis or mixed vaginitis) after thorough gynecological examination and for whom an empirical local treatment is warranted.MedDRA version: 18.0Level: LLTClassification code 10046950Term: VaginitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.0Level: PTClassification code 10046914Term: Vaginal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.0Level: LLTClassification code 10001107Term: Acute vaginitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.0Level: LLTClassification code 10029562Term: Non-specific vaginitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.0Level: PTClassification code 10062167Term: Vaginitis bacterialSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-001759-22-FRaboratoire Innotech International658
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