2023-504727-32-00招募中2 期
A double-blind, randomised, dose-finding trial to assess the efficacy, safety and pharmacokinetics of a single dose of albaconazole versus fluconazole and placebo in the treatment of acute Candida vulvovaginitis
Palau Pharma S.L.23 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2023年9月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 23
- 主要终点
- Percentage of subjects with clinical cure defined as vulvovaginal score sum = 0 at the Final Visit (FV) by treatment group (albaconazole vs. placebo).
研究概览
简要总结
To assess the efficacy of albaconazole (XX, YY or ZZ) compared to placebo with respect to clinical cure in subjects with acute Candida vulvovaginitis.
研究设计
- 分配方式
- Randomized
- 主要目的
- Clinical trial - Cohort 2
- 盲法
- Double (Monitor, Subject, Investigator)
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female post-menarche subjects
- •Diagnosed with acute Candida vulvovaginitis according to the following criteria: a. Two or more of the signs and symptoms of Candida vulvovaginitis (itching, burning, irritation, oedema, redness, or excoriation), with at least one with moderate intensity of vulvovaginal signs and symptoms Grade of symptoms is defined as follows: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. b. Rapid antigen test positive for Candida spp. c. Vaginal pH ≤ 4.4 The diagnosis must be confirmed by a positive Candida spp. culture. Swabs for the culture have to be taken before the intake of IP.
- •Written informed consent/assent given freely after the nature of the trial and disclosure of data has been explained to the subject. In the case of adolescents (post-menarche women younger than 18 years of age at enrolment), assent by the subject must be given as well as consent from parent/legal representative, according to local legislation.
- •For females of childbearing potential only: must use highly effective methods of birth control, e.g. male or female condoms, diaphragms, combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatment). For barrier methods as male condoms, female condoms and diaphragms it is recommended to use 2 methods of birth control.
排除标准
- •Pregnant or lactating subjects.
- •Wish of pregnancy within 4 weeks following treatment.
- •Recurrent Candida vulvovaginitis (4 or more confirmed episodes of Candida spp. vaginal infection over the last 12 months prior to Visit 1).
- •Other active vulvovaginal infection (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex or the human papilloma virus) or mixed infections.
- •Subjects with any other vaginal or vulvar condition which may confound the interpretation of the clinical response to treatment.
- •Known contraindications/hypersensitivity to the trial medication, any of the excipients of the trial medication (protocol Section 10.1 and 10.2) or to azole derivatives.
- •Prior treatment with topical vaginal or vulvar antifungal agents within the last 7 days prior to Visit 1 or with systemic antifungal agents within the last 28 days prior to Visit 1.
结局指标
主要结局
Percentage of subjects with clinical cure defined as vulvovaginal score sum = 0 at the Final Visit (FV) by treatment group (albaconazole vs. placebo).
Percentage of subjects with clinical cure defined as vulvovaginal score sum = 0 at the Final Visit (FV) by treatment group (albaconazole vs. placebo).
次要结局
未报告次要终点
研究者
Scientific Information Desk
Scientific
Palau Pharma S.L.
研究点 (23)
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