EUCTR2016-004268-21-AT进行中（未招募）1 期
A phase IIa randomized, active-controlled, double-blind, dose-escalation study in patients with vulvovaginal candidiasis to evaluate clinical efficacy, safety and tolerability and dose response relationship of topically administered ProF-001
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
- Profem GmbH
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.Premenopausal female patients = 18 years old
- •2.Patients suffering from an acute episode of vulvovaginal candidiasis, characterized by:
- •Positive vaginal smear (native or KOH) for budding yeasts and/or fungal (pseudo-)hyphae, normal (G I) or intermediate flora (G II)*
- •Positive clinical symptoms (itching, burning, irritation, edema, erythema, excoriations), with a subjective symptom score of at least 3 (0=absent, 1=mild, 2=moderate, and 3=severe), with score being at least moderate for at least 1 subjective symptom and itching being present, and a total sign and symptom score of at least 4
- •3.Readiness for sexual abstinence from start of treatment until test of cure (TOC) visit
- •4.Ability to understand trial instructions and rating scales as well as ability to comply with treatment
- •5.Written informed consent prior to enrolment
- •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 84
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known hypersensitivity to clotrimazole, diclofenac or any other ingredient of the investigational medicinal product
- •2.Pregnancy or breast feeding at time of screening
- •3.Menstrual bleeding (spotting is not an exclusion criterion) during the first three days of treatment
- •4.Acute cystitis
- •5.Patients with clinical signs of other infectious causes of vulvovaginitis: bacterial vaginosis (GIII), trichomonas vaginalis, herpes simplex genitalis
- •6.Treatment with antimycotics (systemic or vaginal) within 7 days of randomization
- •7.Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
- •8.Patients with other clinical gynecological abnormalities, such as infections of the upper urogenital tract (pelvic inflammatory disease, adnexitis)
- •9.Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response (e.g. Lichen sclerosus, neuropathic pain)
- •10.Subjects who will be undergoing treatment or surgery for gynecological pathologies during the study period, i.e, cervical intraepithelial neoplasia, cervical carcinoma, other neoplasms
- •11.Known alcohol, drug or medication abuse
- •12.Any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient’s compliance (e.g. known immune deficiency syndrome with clinical relevance at time of screening)
- •13.Participation in another interventional clinical trial within the last 30 days
- •14.Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
研究者
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