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

Primary Purpose

Vaginosis, Bacterial

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Medical Device: WO3191
Medical Device: Vagisan® Lactic Acid
Sponsored by
Dr. August Wolff GmbH & Co. KG Arzneimittel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaginosis, Bacterial focused on measuring Bacterial Vaginosis, BV

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Dr. Gerick
  • Dr. Hofmann
  • Dr. de Brabandt
  • Dr. Werner Göttker-Schnetmann
  • Dr. Deininger
  • Dr. Kränzlin
  • Dr. Kästner
  • Dr. Kühne
  • Bianca Moll-Bosch
  • Dr. Susanne Feidicker
  • Thomas Riepen
  • Dr. Waldschütz
  • Prof. Mendling

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medical Device: WO3191

Medical Device: Vagisan® Lactic Acid

Arm Description

The vaginal suppository is used for the reduction and/or inhibition of vaginal biofilms that were shown to be related to recurrent bacterial vaginosis.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Subjective symptoms (local tolerability)
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)
Objective findings
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
Global judgement of tolerability
Global judgement of tolerability by investigator and patient at Visit 4 (after 3 weeks of application)
AE and ADE (Safety)
Unsolicited AEs and ADEs
Occurrence of AE / SAE / ADE / SADE (Serious Adverse Event) (Safety)
Occurrence of AE / SAE / ADE / SADE
Characteristics of AE / SAE / ADE / SADE (Safety)
Characteristics of occured AE / SAE / ADE / SADE
Change in biofilm EPS
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
Change in pH-value from vaginal smear
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))
Change in Nugent-Score
Nugent-Score at Visit 2 (before the first application), Visit 3 (after 1 week of application) and Visit 4 (after 3 weeks of application)
Change in Vaginal flora
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))
Time to recurrence of BV
Time from the end of application (Visit 4) to the first recurrence of BV within the Follow-up Phase of 12 weeks

Full Information

First Posted
October 12, 2015
Last Updated
February 16, 2016
Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
PHARMALOG Institute for Clinical Research, Bremer Pharmacovigilance Service GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02687789
Brief Title
Safety, Tolerability and Efficacy of Vaginal Suppository WO3191 in the Post-treatment of Bacterial Vaginosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
PHARMALOG Institute for Clinical Research, Bremer Pharmacovigilance Service GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginosis, Bacterial
Keywords
Bacterial Vaginosis, BV

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Device: WO3191
Arm Type
Experimental
Arm Description
The vaginal suppository is used for the reduction and/or inhibition of vaginal biofilms that were shown to be related to recurrent bacterial vaginosis.
Arm Title
Medical Device: Vagisan® Lactic Acid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medical Device: WO3191
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Medical Device: Vagisan® Lactic Acid
Intervention Description
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)
Primary Outcome Measure Information:
Title
Local tolerability of IMD defined as a cumulative sum score of solicited local ADE for each Patient
Description
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).
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Subjective symptoms (local tolerability)
Description
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)
Time Frame
3 weeks
Title
Objective findings
Description
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
Time Frame
3 weeks
Title
Global judgement of tolerability
Description
Global judgement of tolerability by investigator and patient at Visit 4 (after 3 weeks of application)
Time Frame
3 weeks
Title
AE and ADE (Safety)
Description
Unsolicited AEs and ADEs
Time Frame
up to 4 months
Title
Occurrence of AE / SAE / ADE / SADE (Serious Adverse Event) (Safety)
Description
Occurrence of AE / SAE / ADE / SADE
Time Frame
up to 4 months
Title
Characteristics of AE / SAE / ADE / SADE (Safety)
Description
Characteristics of occured AE / SAE / ADE / SADE
Time Frame
up to 4 months
Title
Change in biofilm EPS
Description
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
Time Frame
up to 4 months
Title
Change in pH-value from vaginal smear
Description
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))
Time Frame
within 4 months
Title
Change in Nugent-Score
Description
Nugent-Score at Visit 2 (before the first application), Visit 3 (after 1 week of application) and Visit 4 (after 3 weeks of application)
Time Frame
within 3 weeks
Title
Change in Vaginal flora
Description
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))
Time Frame
within 4 months
Title
Time to recurrence of BV
Description
Time from the end of application (Visit 4) to the first recurrence of BV within the Follow-up Phase of 12 weeks
Time Frame
up to 3 months
Other Pre-specified Outcome Measures:
Title
Global judgement of the IMD
Description
Global judgement of the IMD by investigator and patient
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Christoph Abels, MD
Organizational Affiliation
Dr. August Wolff GmbH & Co. KG Arzneimittel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof. Werner Mendling, MD
Organizational Affiliation
St. Anna Klinik, Wuppertal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Gerick
City
Aachen
Country
Germany
Facility Name
Dr. Hofmann
City
Betzdorf
Country
Germany
Facility Name
Dr. de Brabandt
City
Bielefeld
Country
Germany
Facility Name
Dr. Werner Göttker-Schnetmann
City
Frankfurt
Country
Germany
Facility Name
Dr. Deininger
City
Munich
Country
Germany
Facility Name
Dr. Kränzlin
City
Munich
Country
Germany
Facility Name
Dr. Kästner
City
Munich
Country
Germany
Facility Name
Dr. Kühne
City
Munich
Country
Germany
Facility Name
Bianca Moll-Bosch
City
Siegen
Country
Germany
Facility Name
Dr. Susanne Feidicker
City
Steinhagen
Country
Germany
Facility Name
Thomas Riepen
City
Weilburg
Country
Germany
Facility Name
Dr. Waldschütz
City
Wuppertal
Country
Germany
Facility Name
Prof. Mendling
City
Wuppertal
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28903767
Citation
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.
Results Reference
derived
PubMed Identifier
28807017
Citation
Gottschick 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.
Results Reference
derived

Learn more about this trial

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

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