A Prospective Parallel-design, Double-blind, Randomised, Controlled Investigation to Gain Clinical Experience and Further Knowledge About the Certified Medical Device Vaginal Suppository WO 3191 With Respect to Safety, Tolerability and Efficacy in the Post-Treatment of Bacterial Vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 13
- 主要终点
- Local tolerability of IMD defined as a cumulative sum score of solicited local ADE for each Patient
研究概览
简要总结
Bacterial Vaginosis (BV) is a common infectious disorder and is characterized by a disturbance in the vaginal microbiological milieu. Anaerobic bacteria, such as Gardnerella vaginalis and Atopobium vaginae overgrow the physiologic vaginal flora which is dominated by Lactobacilli. BV can arise and remit spontaneously but often presents as a recurrent disease.
New findings indicate that the presence of an adherent bacterial biofilm on the vaginal mucosa seems to be the reason for the recurrence of BV as well as the overgrowth condition by anaerobic bacteria. Biofilms are defined as a structured consortium of bacteria embedded in a matrix of extracellular polymeric substances (EPS).
The purpose of this study is to achieve substantial results with respect to tolerability and safety, and to gain further knowledge on the clinical efficacy of Vaginal suppository WO3191, the investigation will be performed in a parallel-design, double-blind, randomised, controlled manner.
详细描述
This investigation is a multicentre, parallel-group, double-blind, controlled trial with an open Follow-up Phase of 12 weeks. It is conducted to gain clinical experience and further knowledge about the certified medical device Vaginal suppository WO3191 in women with bacterial vaginosis.
In this investigation the Investigational Medical Device (IMD) will be used as post-treatment following standard therapy with oral metronidazole for BV. IMD will be applied 2 times a week for 3 weeks.
The primary purpose is the evaluation of the safety and local tolerability of WO3191, therefore all adverse events (AEs) and adverse device effects (ADEs) will be documented. Furthermore, patients will be asked for possibly arising subjective vaginal symptoms (burning, itching, bleeding, pain, dryness) and will be examined for possibly arising objective vaginal findings (redness, petechial bleeding, dryness, swelling).
The secondary purpose of this investigation is to gain clinical experience and further knowledge about Vaginal suppository WO3191 with respect to the efficacy in the post-treatment of bacterial vaginosis.
In addition pH-values and microbiological data shall be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed declaration of consent and signed data protection declaration after having been informed about the nature, relevance and the scope of the investigation and about the expected desired and undesired effects of the IMD
- •Premenopause, age 18 to 50 years (incl. patients with Intrauterine device, e.g. Mirena® with amenorrhoea)
- •Acute BV (at least 3 of 4 Amsel's Criteria fulfilled and Nugent Score > 6)
- •Existing bacterial biofilm in the vagina, verified by positive EPS of bacterial biofilm and by microscopy
- •Requirement of oral treatment of metronidazole for BV
排除标准
- •Postmenopause (no menses in the last six months prior to enrolment)
- •Positive Herpes simplex infection
- •Positive Candida spp. infection
- •Positive Trichomonas spp. infection
- •Pathologic PAP (III, III D-V) within the last 3 months
- •Chronic immunosuppressive diseases (i.e. HIV) or treatment (i.e. transplantation)
- •Malignant conditions of CIN, VIN or VAIN, currently and / or within the past 6 months
- •Presence or history (within the last 5 years) of any other malignancy
- •Previous chemotherapy (within 6 months before start of this investigation)
- •Current vaginal or systemic treatment with antibiotics or corticosteroids, systemic treatment with NSAIDs (nonsteroidal anti-inflammatory drugs) within the last two weeks prior to start of this investigation (except metronidazole for the treatment of BV: prescription of metronidazole before investigation entry; except NSAIDs taken in a single dose in case of need, e.g. for headache)
- •Use of not permitted contraception or not willing to use contraception (Allowed contraception: oral hormonal contraceptives, intrauterine device, surgical, sexual abstinence; Not permitted contraception: condoms, local spermicides, intravaginal contraceptive measures)
- •Pregnancy or lactation
- •Active Smokers (more than 5 cigarettes per day)
- •Use of any other intravaginal medicinal product or medical device (including all intravaginal contraceptive measures (e.g. NuvaRing®, local spermicides)
- •Known hypersensitivity to one or more of the active and / or inactive ingredients of the antibiotic treatment (metronidazole: mandatory for inclusion)
- •Known hypersensitivity to one or more of the ingredients of the IMD (test product and/or comparator)
研究组 & 干预措施
Medical Device: WO3191
The vaginal suppository is used for the reduction and/or inhibition of vaginal biofilms that were shown to be related to recurrent bacterial vaginosis.
干预措施: Medical Device: WO3191 (Other)
Medical Device: Vagisan® Lactic Acid
It is used for the maintenance and restoration of a natural pH level in the vagina. The acidification of the vaginal milieu with lactic acid promotes the growth of typical vaginal flora (lactic acid bacteria) and is unfavourable for the growth of pathogens in the vagina. Vagisan® Lactic Acid is used in the post-treatment of bacterial vaginosis.
干预措施: Medical Device: Vagisan® Lactic Acid (Other)
结局指标
主要结局
Local tolerability of IMD defined as a cumulative sum score of solicited local ADE for each Patient
时间窗: 3 weeks
Local tolerability of the IMD will be defined as a cumulative sum score of the solicited local (vaginal) ADE (consisting of subjectively experienced symptoms rated by the patient: burning, itching, bleeding, pain, dryness and objectively documented findings rated by the physician: redness, petechial bleeding, dryness, swelling) for each patient after 1 and 3 weeks of application (Visit 3 and Visit 4, respectively).
次要结局
- Characteristics of AE / SAE / ADE / SADE (Safety)(up to 4 months)
- Subjective symptoms (local tolerability)(3 weeks)
- Objective findings(3 weeks)
- Global judgement of tolerability(3 weeks)
- AE and ADE (Safety)(up to 4 months)
- Occurrence of AE / SAE / ADE / SADE (Serious Adverse Event) (Safety)(up to 4 months)
- Change in biofilm EPS(up to 4 months)
- Change in pH-value from vaginal smear(within 4 months)
- Change in Nugent-Score(within 3 weeks)
- Change in Vaginal flora(within 4 months)
- Time to recurrence of BV(up to 3 months)