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

NCT ID: NCT02687789

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-09-30

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.

Conditions

Vaginosis, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Medical Device: WO3191

Intervention Type: OTHER

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)

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.

Group Type: ACTIVE_COMPARATOR

Medical Device: Vagisan® Lactic Acid

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PHARMALOG Institute for Clinical Research

UNKNOWN

Sponsor Role: collaborator

Bremer Pharmacovigilance Service GmbH

OTHER

Sponsor Role: collaborator

Dr. August Wolff GmbH & Co. KG Arzneimittel

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Christoph Abels, MD

Role: STUDY_DIRECTOR

Dr. August Wolff GmbH & Co. KG Arzneimittel

Prof. Werner Mendling, MD

Role: PRINCIPAL_INVESTIGATOR

St. Anna Klinik, Wuppertal

Locations

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

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 28903767 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28807017 (View on PubMed)

Other Identifiers

CIV-113-12-011731

Identifier Type: OTHER

Identifier Source: secondary_id

WOAF-11/2012

Identifier Type: -

Identifier Source: org_study_id