An Academic study to evaluate Laphre – A Vaginal Pessary for treatment of Bacterial Vaginosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The study would give an understanding of how the formulation Laphre - vaginal pessary is effective for treating bacterial vaginosis.
研究概览
简要总结
Adult women with confirmed BV presenting to the hospital would be enrolled in the study after obtaining informed consent. The patients would undergo a thorough gynaecological examination and vaginal samples would be taken and analysed. The patients will be then given details on the administration of the investigational product, capsule containing the formulation, which has to be self-administered bid (1-0-1) for 7 days. The patients will be given the investigational product. On Day 7, patients will be re-examined based on Amsel criteria of BV to determine whether BV has been cured and if required prolonged treatment would be advised for additional one week.
Patients would be followed up through telephone for 30 days (twice a week) from the last day of visit for any recurrence. Vaginal samples taken at the start and end of study will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability of the vaginal pessary and adverse events (AEs) if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult, post-menarchal, pre-menopausal women aged 18 years or older
- •Diagnosis of bacterial vaginosis according to Amsels criteria, defined as having at least 3 of the 4 following criteria a)Thin, white, yellow, homogenous discharge b) Clue cells on microscopy (more than 20 percent of epithelial cells) c) pH of vaginal fluid above 4.5 d) Release of fishy odor i.e. a positive whiff test when alkali (10 percent potassium hydroxide solution is added
- •Having decisional capacity and providing written informed consent
- •Negative urine pregnancy test at screening
- •Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
- •Refrain from sexual intercourse or use a condom until Day 7
- •Signed informed consent and willing and able to comply with all study requirements.
排除标准
- •Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoea, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
- •Anticipated menstruation during the treatment period (Day 0 till Day 7)
- •Patients who are pregnant or breastfeeding
- •Patients who were treated for bacterial vaginosis within the past 14 days
- •Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days
- •Patients who have used pH modifying vaginal products within the last 14 days
- •Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
- •Known or previous allergy or hypersensitivity to any product constituent 9.Any medical condition that in the Investigator judgments would make the patient unsuitable for inclusion.
结局指标
主要结局
The study would give an understanding of how the formulation Laphre - vaginal pessary is effective for treating bacterial vaginosis.
时间窗: Two months
次要结局
- The clinical observations would help in design and conduct of clinical trials of this formulation for treatment of Bacterial Vaginosis.(Two months)