Safety, Tolerability and Efficacy of Vaginal Suppository WO3191 in the Post-treatment of Bacterial Vaginosis

February 16, 2016 updated by: Dr. August Wolff GmbH & Co. KG Arzneimittel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Furthermore, the difference between Vaginal suppository WO3191 (Group A) and the comparator (Vagisan® Lactic Acid, group B) with respect to the safety, tolerability and the efficacy in the post-treatment of bacterial vaginosis shall be evaluated exploratively.

Patients who have completed all regular visits (Visit 1 - 4; Visit 1 - Screening, Visit 2 - Randomization, Start of application of IMD; Visit 3 - one week after Visit 2; Visit 4 - two weeks after Visit 3, End of application of IMD) of the investigation shall attend an observational Follow-up Phase of 12 weeks with a final Visit 5. At Visit 5 recurrences of BV as well as the sustainability of the efficacy of Vaginal suppository WO3191 will be evaluated.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Dr. Gerick
      • Betzdorf, Germany
        • Dr. Hofmann
      • Bielefeld, Germany
        • Dr. de Brabandt
      • Frankfurt, Germany
        • Dr. Werner Göttker-Schnetmann
      • Munich, Germany
        • Dr. Deininger
      • Munich, Germany
        • Dr. Kränzlin
      • Munich, Germany
        • Dr. Kästner
      • Munich, Germany
        • Dr. Kühne
      • Siegen, Germany
        • Bianca Moll-Bosch
      • Steinhagen, Germany
        • Dr. Susanne Feidicker
      • Weilburg, Germany
        • Thomas Riepen
      • Wuppertal, Germany
        • Dr. Waldschütz
      • Wuppertal, Germany
        • Prof. Mendling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Medical Device: WO3191
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)
Active Comparator: 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.
Other: Medical Device: Vagisan® Lactic Acid
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tolerability of IMD defined as a cumulative sum score of solicited local ADE for each Patient
Time Frame: 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).
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective symptoms (local tolerability)
Time Frame: 3 weeks
Each of the subjective symptoms (scored from 0 [none/normal] to 3 [severe]) at Visit 2 (before the first application), Visit 3 (after 1 week of application) and Visit 4 (after 3 weeks of application)
3 weeks
Objective findings
Time Frame: 3 weeks
Each finding (scored from 0 [none/normal] to 3 [severe]) as well as each sum score at Visit 3 (after 1 week of application) and Visit 4 (after 3 weeks of application) will be summarised by the maximum value and the mean value for Visit 3 and Visit 4, respectively
3 weeks
Global judgement of tolerability
Time Frame: 3 weeks
Global judgement of tolerability by investigator and patient at Visit 4 (after 3 weeks of application)
3 weeks
AE and ADE (Safety)
Time Frame: up to 4 months
Unsolicited AEs and ADEs
up to 4 months
Occurrence of AE / SAE / ADE / SADE (Serious Adverse Event) (Safety)
Time Frame: up to 4 months
Occurrence of AE / SAE / ADE / SADE
up to 4 months
Characteristics of AE / SAE / ADE / SADE (Safety)
Time Frame: up to 4 months
Characteristics of occured AE / SAE / ADE / SADE
up to 4 months
Change in biofilm EPS
Time Frame: up to 4 months

Proof of the biofilm EPS at Visit 2 (before the first application), Visit 3 (after 1 week of application), Visit 4 (after 3 weeks of application) and Visit 5 (after Follow-up Phase, i.e.12 weeks after the end of the application Phase (Visit 4))

Combined Parameter: Evaluation of Extracellular Polymeric Substances (EPS) in urine samples and evaluation of existence of bacterial biofilm
up to 4 months
Change in pH-value from vaginal smear
Time Frame: within 4 months
pH-value from vaginal smear at visit 2 (before the first application), Visit 3 (after 1 week of application), Visit 4 (after 3 weeks of application) and Visit 5 (after Follow-up Phase, i.e.12 weeks after the end of the application Phase (Visit 4))
within 4 months
Change in Nugent-Score
Time Frame: within 3 weeks
Nugent-Score at Visit 2 (before the first application), Visit 3 (after 1 week of application) and Visit 4 (after 3 weeks of application)
within 3 weeks
Change in Vaginal flora
Time Frame: within 4 months
Vaginal flora (Lactobacillus spp., Atopobium vaginae and Gardnerella vaginalis) at Visit 2 (before the first application), Visit 3 (after 1 week of application) Visit 4 (after 3 weeks of application) and Visit 5 (after Follow-up Phase, i.e.12 weeks after the end of the application Phase (Visit 4))
within 4 months
Time to recurrence of BV
Time Frame: up to 3 months
Time from the end of application (Visit 4) to the first recurrence of BV within the Follow-up Phase of 12 weeks
up to 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global judgement of the IMD
Time Frame: 3 weeks
Global judgement of the IMD by investigator and patient
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Collaborators

Bremer Pharmacovigilance Service GmbH
PHARMALOG Institute for Clinical Research

Investigators

  • Study Director: Prof. Christoph Abels, MD, Dr. August Wolff GmbH & Co. KG Arzneimittel
  • Principal Investigator: Prof. Werner Mendling, MD, St. Anna Klinik, Wuppertal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WOAF-11/2012
  • CIV-113-12-011731 (Other Identifier: EUDRAMED - European Database on Medical Devices)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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