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Vaginosis, BacterialNCT02687789

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

A study testing Medical Device: WO3191 and Medical Device: Vagisan® Lactic Acid in people with Vaginosis, Bacterial, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 13 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Vaginosis, Bacterial
What is being tested?
Medical Device: WO3191 and Medical Device: Vagisan® Lactic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
13 sitesGermany
Study dates
Apr 2014to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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)

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • Dr. Gerick

    Aachen

  • Dr. Hofmann

    Betzdorf

  • Dr. de Brabandt

    Bielefeld

  • Dr. Werner Göttker-Schnetmann

    Frankfurt

  • Dr. Deininger

    Munich

  • Dr. Kränzlin

    Munich

  • Dr. Kästner

    Munich

  • Dr. Kühne

    Munich

  • Bianca Moll-Bosch

    Siegen

  • Dr. Susanne Feidicker

    Steinhagen

  • Thomas Riepen

    Weilburg

  • Dr. Waldschütz

    Wuppertal

  • Prof. Mendling

    Wuppertal

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Medical Device: WO3191, Medical Device: Vagisan® Lactic Acid
Keywords
Bacterial Vaginosis, BV
Medical subject headings
Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical Device: WO3191Other

    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 AcidOther

    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)

Study groups in NCT02687789
Study groupRoleWhat they receive
Medical Device: WO3191ExperimentalThe vaginal suppository is used for the reduction and/or inhibition of vaginal biofilms that were shown to be related to recurrent bacterial vaginosis.
Receives: Other: Medical Device: WO3191
Medical Device: Vagisan® Lactic AcidActive 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.
Receives: Other: Medical Device: Vagisan® Lactic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 weeks

Secondary outcomes (11)

  1. 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)

    Measured: 3 weeks

  2. 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

    Measured: 3 weeks

  3. Global judgement of tolerability

    Global judgement of tolerability by investigator and patient at Visit 4 (after 3 weeks of application)

    Measured: 3 weeks

  4. AE and ADE (Safety)

    Unsolicited AEs and ADEs

    Measured: up to 4 months

  5. Occurrence of AE / SAE / ADE / SADE (Serious Adverse Event) (Safety)

    Occurrence of AE / SAE / ADE / SADE

    Measured: up to 4 months

  6. Characteristics of AE / SAE / ADE / SADE (Safety)

    Characteristics of occured AE / SAE / ADE / SADE

    Measured: up to 4 months

  7. 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

    Measured: up to 4 months

  8. 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))

    Measured: within 4 months

  9. 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)

    Measured: within 3 weeks

  10. 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))

    Measured: within 4 months

  11. 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

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2016 (estimated)
  2. Study startApr 2014
  3. Primary completionJul 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02687789
Sponsor's protocol ID
WOAF-11/2012
Other IDs
CIV-113-12-011731
Status last verified
Feb 2016
First submitted
12 Oct 2015
Last updated
22 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28903767

  • 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.

    PubMed 28807017

Questions about this trial

What is this clinical trial studying?

A study testing Medical Device: WO3191 and Medical Device: Vagisan® Lactic Acid in people with Vaginosis, Bacterial, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local tolerability of IMD defined as a cumulative sum score of solicited local ADE for each Patient (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02687789, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.

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