EUCTR2016-002808-19-BG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
A.C.R.A.F. S.p.A. (Aziende Chimiche Riunite Angelini Francesco)0 个研究点目标入组 445 人开始时间: 2017年7月3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
- 445
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 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 and women in a postmenopausal state. Females of childbearing potential and women with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to Visit 4, using an appropriate birth control method such as combined estrogen-progestin containing hormonal contraceptives (e.g. oral, transdermal), progestin-only hormonal contraceptives (e.g. oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
- •Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
- •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:
- •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 and pregnant women.
- •3. Patients suffering from vaginitis of different etiology, bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma virus, according to the medical history, physical and gynecological examination
- •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. Intravaginal hormonal contraceptives and male condoms are not 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 end-points 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
相似试验
进行中（未招募）
1 期
Treatment of infectious diseases and disorders affecting the female sex organs;EUCTR2016-002808-19-PLAziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.440
进行中（未招募）
1 期
Treatment of infectious diseases and disorders affecting the female sex organs.ncomplicated vulvovaginal candidosis (VVC)MedDRA version: 20.1Level: LLTClassification code 10047783Term: Vulvovaginal candidaSystem Organ Class: 100000004862EUCTR2016-002808-19-ITAZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.440
进行中（未招募）
3 期
A phase III clinical study in patients with active rheumatoid arthritis who show an inadequate response or intolerance to previous or current treatmentRheumatoid ArthritisJPRN-jRCT2011220026Okugaito Izumi113
已完成
3 期
A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.prostate cancer that can't be treated surgically1003859710036958NL-OMON43687Celgene Corporation136
已完成
不适用
A phase 3 study to determine the efficacy and safety of recombinant human activated protein C in severe sepsisSevere sepsisInfections and InfestationsSepsisISRCTN74215569Eli Lilly and Company (USA)1,690