Safety, Tolerability and Efficacy of Vaginal Suppository WO3191 in the Post-treatment of Bacterial Vaginosis
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
2 other identifiers
interventional
43
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedFebruary 22, 2016
February 1, 2016
1.2 years
October 12, 2015
February 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local tolerability of IMD defined as a cumulative sum score of solicited local ADE for each Patient
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).
3 weeks
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Other Outcomes (1)
Global judgement of the IMD
3 weeks
Study Arms (2)
Medical Device: WO3191
EXPERIMENTALThe vaginal suppository is used for the reduction and/or inhibition of vaginal biofilms that were shown to be related to recurrent bacterial vaginosis.
Medical Device: Vagisan® Lactic Acid
ACTIVE COMPARATORIt 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.
Interventions
application of vaginal suppository WO3191: 2 days per week (with a treatment-free interval of three days or two days, respectively; e.g. Monday and Friday)
application of Vagisan® Lactic Acid: 2 days per week (with a treatment-free interval of three days or two days, respectively; e.g. Monday and Friday)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 ingredients of the IMD (test product and/or comparator)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Dr. Gerick
Aachen, Germany
Dr. Hofmann
Betzdorf, Germany
Dr. de Brabandt
Bielefeld, Germany
Dr. Werner Göttker-Schnetmann
Frankfurt, Germany
Dr. Deininger
Munich, Germany
Dr. Kränzlin
Munich, Germany
Dr. Kästner
Munich, Germany
Dr. Kühne
Munich, Germany
Bianca Moll-Bosch
Siegen, Germany
Dr. Susanne Feidicker
Steinhagen, Germany
Thomas Riepen
Weilburg, Germany
Dr. Waldschütz
Wuppertal, Germany
Prof. Mendling
Wuppertal, Germany
Related Publications (2)
Gottschick C, Deng ZL, Vital M, Masur C, Abels C, Pieper DH, Rohde M, Mendling W, Wagner-Dobler I. Treatment of biofilms in bacterial vaginosis by an amphoteric tenside pessary-clinical study and microbiota analysis. Microbiome. 2017 Sep 13;5(1):119. doi: 10.1186/s40168-017-0326-y.
PMID: 28903767DERIVEDGottschick C, Deng ZL, Vital M, Masur C, Abels C, Pieper DH, Wagner-Dobler I. The urinary microbiota of men and women and its changes in women during bacterial vaginosis and antibiotic treatment. Microbiome. 2017 Aug 14;5(1):99. doi: 10.1186/s40168-017-0305-3.
PMID: 28807017DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Prof. Christoph Abels, MD
Dr. August Wolff GmbH & Co. KG Arzneimittel
- PRINCIPAL INVESTIGATOR
Prof. Werner Mendling, MD
St. Anna Klinik, Wuppertal
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
February 22, 2016
Study Start
April 1, 2014
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
February 22, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share