EUCTR2016-002808-19-IT进行中（未招募）1 期
Phase III study to evaluate the efficacy of a novel antimycotic vaginal pessary combination (containing Benzydamine HCl 6 mg and Econazole nitrate 150 mg) in the Treatment of uncomplicated vulvovaginal candidosis (VVC) [BEtreat study] - BEtreat study
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.0 个研究点目标入组 440 人开始时间: 2018年8月1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
- 440
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. Females between 18 and 65 years of age (limits included), with no limitation of race.
- •2. Patients clinically diagnosed with uncomplicated VVC, as confirmed by a positive vaginal wet mount test.
- •3. Patients presenting at baseline a total score = 3 in the subjective symptoms and a total score = 1 in the objective signs.
- •4. Female of childbearing potential must have a negative pregnancy test at Visit 0 and agree to refrain from sexual intercourse from the signature of the informed consent up to Visit 4.
- •5. Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.
- •2. Lactating women.
- •3. Patients suffering from vaginitis of different etiology.
- •4. Treatment with systemic antifungal drugs within 4 weeks or with topical antifungal drugs within 1 week before Visit 0.
- •5. Use of any topical drugs on the application area and systemic drugs, including over the counter, oral anticoagulants (i.e. warfarin or acenocoumarol), anti-inflammatory and/or analgesic drugs, antibiotics
- •or antibacterials, within 2 weeks before Visit 0. Hormonal contraceptives and hormonal replacement therapies are allowed.
- •6. Patients with actual menstruation at Visit 0 or expected menstruation within 11 days after Visit 0.
- •7. Clinically significant abnormalities at physical examination, vital signs, ECG, laboratory tests at Visit 0.
- •8. Patients suffering from gynecological diseases (genital tract abnormalities, lichen sclerosus, post-operative alterations of the genital
- •tract, genital tract neoplasm) that may interfere with the study endpoints and/or procedures.
- •9. Immunocompromised patients or patients affected by non-controlled diabetes, or patients being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives), which may predispose to mycological infections.
- •10. Signs or symptoms or clinical documentation for concurrent infections (including but not limited to sexually transmitted infections) and/or neoplasm.
- •11. Patients suffering from chronic/recurrent vulvovaginal mycosis, defined as four or more mycological proven symptomatic episodes
- •during the last 12 months.
- •12. Inability to comply with the protocol requirements, instructions or study-related restrictions (i.e. uncooperative attitude, inability to return for study visits, unlikelihood of completing the clinical study).
- •13. Vulnerable patients (i.e. persons kept in detention).
- •14. Subjects involved in the conduct of the study (i.e. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel).
- •15. Participation to an interventional clinical trial within 3 months prior to Visit 0.
研究者
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