Open-Label Post Market Clinical Follow up Investigation to Evaluate the Clinical Performance and Safety / Tolerability of Lactal Gel for Treatment of Bacterial Vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percent of Bacterial Vaginosis (BV)-free subjects
研究概览
简要总结
The aim of this study is to find out how well the medical device Lactal Gel works and how safe it is. The product will be used to treat bacterial vaginosis in a group of fifty women aged 18 years or older.
All participants will receive the one-week treatment as part of their usual medical care.
Each participant will have two visits: one at the beginning of the study (the initial assessment) and another at day 11 (the final visit).
During these visits, the doctor will:
- Perform a normal medical check-up
- Diagnose bacterial vaginosis using the Amsel criteria (which include checking vaginal pH, appearance of discharge, odor, and microscopic examination)
- Ask about symptoms such as odor, discomfort, and itching
- Evaluate, together with the patient, how well the treatment is working
- Assess the patient's satisfaction and how easy the product is to use
- Check that the treatment is safe and well tolerated The results of this study will help doctors choose the most effective and safest treatment for bacterial vaginosis.
详细描述
The objective of this study is to evaluate the safety and effectiveness of Lactal Gel, a new medical device that is administered vaginally for the treatment of bacterial vaginosis (BV). One group of patients aged 18 years or older who have been diagnosed with BV according to the Amsel criteria will be treated with the tested device for one week. This treatment will be in accordance with the instructions for use of the tested device and the standard usual care of the involved center. The administration of any preparations that may influence the study outcome within the previous three weeks (e.g., antibiotics, antimycotics, probiotics) is prohibited. To diagnose BV, the presence of at least three of the following is required:
- pH >4.5;
- increased thin vaginal discharge;
- amine odor when KOH (Potassium Hydroxide) solution is added to vaginal secretions (Whiff test);
- presence of clue cells in wet preparations.
Patients will be visited at baseline and at day 11 ± 2 (final visit).
The primary outcomes are:
- percentage of BV-free subjects at the final visit.
- Amsel criteria total score at the final visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participation was based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
- •Age ≥ 18 years old, including women of non- childbearing potential such as women after menopause, i.e 12 months after last menstruation
- •Newly diagnosed BV episode, based on Amsel criteria (Amsel et al., 1983), i.e. presence of three of the following criteria: increased homogeneous thin vaginal discharge; pH of the secretion >4.5; amine odor when potassium hydroxide (KOH) 10% solution is added to a drop of vaginal secretions; presence of clue cells in wet preparations.
- •Suffering from symptoms associated with BV, such as unusual vaginal discharge, odour and discomfort
- •Having access to a smartphone or a computer with an internet access and familiar with the use thereof
- •to use the Investigational Medical Device (IMD) as recommended (in particular, for 7 consecutive days during the non-bleeding period of the menstrual cycle)
- •to avoid the use of any other interventional options for BV during the study (other than the IMD)
- •to avoid the use of any other intravaginal product (e.g. suppositories, gels, foams, lubricants, disinfectants, chemically based contraceptives etc.) during the study
- •to fill in the electronic Diary (eDiary)
- •Commitment to use contraception methods (with the exception of those defined in the previous inclusion criterion)
- •Readiness not to participate in another clinical study during this study
- •Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at baseline visit
排除标准
- •Known allergy or hypersensitivity to the components of the IMD (self-reported)
- •Manifested or suspected Candida infection or any other vaginal mycosis
- •Trichomoniasis
- •Urogenital (dipstick testing), anal or rectal infection within the 3 weeks prior to (self-reported) / at baseline
- •History of recurrent genital herpes (self-reported)
- •Lesions/infections in the vaginal area
- •Use of preparations that may influence the study outcome within the last 3 weeks prior to Baseline and during the study (e.g. antibiotics, antimycotics, probiotics, corticosteroids etc.)
- •History in the past 6 months prior to baseline or presence of a sexually transmitted disease (self-reported)
- •History or presence of any other clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject
- •Pregnancy, nursing or within first 3 months post-partum
- •History of or current abuse of drugs, alcohol or medication
- •Participation in another study during the last 30 days prior to baseline
- •Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
结局指标
主要结局
Percent of Bacterial Vaginosis (BV)-free subjects
时间窗: day 11 ± 2 (final visit)
Percentage of BV-free subjects evaluated by Amsel criteria (at least of 3 of 4 criteria) and score
Amsel parameter total sum
时间窗: day 11 ± 2 (final visit)
Change in mean of the total sum of Amsel criteria scored as follows: * pH \>4.5=1; pH ≤4.5=0 * increase thin vaginal discharge=1; not increased thin vaginal discharge=0 * Whiff test positive=1; whiff test negative=0 * presence of clue cells in wet preparations=1; absence of clue cells in wet preparations=0
次要结局
- Patient Global Safety Evaluation(day 11 ± 2)
- Incidence of Deficiencies(day 11 ± 2)
- Subjective vaginal odor(day 11 ± 2)
- Subjective discomfort(day 11 ± 2)
- Subjective itching(day 11 ± 2)
- Investigator global evaluation(day 11 ± 2)
- Patient global evaluation(day 11 ± 2)
- Incidence of adverse events(day 11 ± 2)
- Investigator Global Safety Evaluation(day 11 ± 2)
- Patient Global Safety Evaluation(day 11 ± 2)
- Incidence of Deficiencies(day 11 ± 2)