2024-515332-80-00招募中3 期
A Phase III, randomized, open label, non-inferiority study comparing the efficacy and safety of furazidin vaginal tablets and clindamycin vaginal cream in the local treatment of bacterial vaginosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical cure rate at Visit 3 (test of cure, Day 8-10), based on Amsel criteria. Clinical cure is defined as the resolution of the abnormal vaginal discharge, a negative whiff test, and the presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount.
研究概览
简要总结
Primary objective is to demonstrate that the treatment with furazidin 5 mg vaginal tablets is not less effective than treatment with clindamycin 2% vaginal cream.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A written informed consent signed before any study-specific evaluation is performed.
- •Female patients with age ≥ 18 ≤ 65
- •Patients with bacterial vaginosis, diagnosed based on Amsel’s criteria.
- •PAP Results-Negative test result for intraepithelial lesion (LSIL), High-Grade Squamous Intraepithelial Lesion (HSIL), or malignancy in the past 12 months. If rial participants do not have a negative test result for LSIL, HSIL or malignancy in the past 12 months, PAP smear/tests in accordance with the Bethesda classification will be performed during screening. In circumstances where the results of the PAP smear are pending at the time of randomization, eligible trial participants may be randomized. In the case of ASCUS result (previous or from screening), test should be repeated in first possible term.
- •Women must have a negative pregnancy test before randomization and may not be lactating or planning to become pregnant during the study period up to Long Term Follow Up Visit 5
- •Agreement of female trial participant of childbearing potential to use highly effective methods of contraception according CTGA vr. 1.2 07Mar2024 (method that can achieve a failure rate of <1% per year when used consistently and correctly e.g. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestin intrauterine device, all oral contraceptives, transdermal hormonal contraceptives with exception of spermicides, or diaphragms, intravaginal contraception) or to abstain from heterosexual intercourse from screening up to Long Term Follow Up Visit
- •For postmenopausal female trial participants it should no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •Willing to refrain from the use of intravaginal products during the treatment period (including spermicides, condoms, tampons etc.)
- •The positive result of BV blue test
排除标准
- •Patients with active clinical symptoms of other infectious causes of vulvovaginitis-Vulvovaginal candidiasis, HSV or HPV).
- •History of recurrent bacterial vaginosis (≥3 episodes per period) in medical history within last 12 months.
- •Clinically significant cardiovascular function impairment-NYHA scale 3 and
- •Uncontrolled severe hypertension ≥180/110 mmHg.
- •Uncontrolled diabetes HbA1C ≥7.5%.
- •Episodes of venous or arterial thromboembolism in Medical History.
- •Undiagnosed abnormal vaginal bleeding, genital tumors (excluding myoma) which in opinion of investigator are clinically significant.
- •Pregnancy and/or breastfeeding
- •Participation in any other trial 30 days before initiation of the study.
- •Dementia or altered mental status that would prohibit informed consent process.
- •Use spermicides, or diaphragms, intravaginal contraception delivery system, probiotics, hygiene products containing probiotics during the study.
- •Patients with positive test results for Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Syphilis.
- •Diagnosed human immunodeficiency virus (HIV) seropositivity or clinically diagnosed acquired immunodeficiency syndrome (AIDS) or its related complex.
- •Diagnosed hepatitis B or C viral infection.
- •Immunosuppressive condition (e.g., end-stage renal disease) or is currently taking immunosuppressants, (e.g., steroids for systemic use, cyclosporine); Inhaled steroids and locally applied steroids are not considered immunosuppressive therapy.
- •Malignancy of any type diagnosed within last 5 years.
- •Any other condition the Investigator believes would interfere with the trial participant’s ability to provide informed consent, comply with study instructions, or puts the trial participant at undue risk.
- •Women currently menstruating or expecting menstruation within 1 week.
- •Patients with another vaginal or vulvar condition, which would confound the interpretation of the clinical response.
- •Use of any other local or systemic bactericidal/bacteriostatic, anti-protozoa or antifungal agent within the 2 weeks prior to the study start.
- •Known hypersensitivity/allergy to active ingredients or any of the excipients of the study medications (including lincomycin).
- •History of antibiotic-associated colitis in medical history.
- •History vaginismus, dyspareunia in medical history.
- •Urinary tract infection within the 2 weeks prior to the study start and during screening. Uncomplicated UTI patients described as presence of at least two of the following clinical symptoms: dysuria, urinary frequency, urinary urgency, suprapubic pain.
- •Hepatic impairment with AST or ALT >5 x Upper Limit of Normal Clinically significant kidney function impairment (eGFR<60 ml/min/1.73m2).
结局指标
主要结局
Clinical cure rate at Visit 3 (test of cure, Day 8-10), based on Amsel criteria. Clinical cure is defined as the resolution of the abnormal vaginal discharge, a negative whiff test, and the presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount.
Clinical cure rate at Visit 3 (test of cure, Day 8-10), based on Amsel criteria. Clinical cure is defined as the resolution of the abnormal vaginal discharge, a negative whiff test, and the presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount.
次要结局
- Percentage of participants with Nugent score ranging from 0 to 3 (Visit 4, Day 21-30).
- Percentage of participants who achieved clinical cure at Visit 3 (Test of cure, Day 8-10) and had a Nugent score ranging from 0 to 3 (Visit 4, Day 21-30).
- Incidence of adverse events (AEs) and serious adverse events (SAEs), both related and unrelated to the investigational medicinal product (IMP).
- Percentage of Bacterial Vaginosis recurrences within 12 weeks of follow-up (assessed with Amsel criteria) in participants who achieved clinical cure status at Visit 3 (Day 8-10).
- Assessment of participants’ quality of life based on VAS scale from the baseline visit to the end of the observation (Visit 5, at least in 13 or 14 week after end of treatment).
研究者
Blanka Seklecka
Scientific
Adamed Pharma S.A.
研究点 (2)
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