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Treatment Comparison of Antibiotics Versus Vaginal Lactic Acid in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborator:
Tentan AG
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT02042287
First received: January 20, 2014
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

Bacterial vaginosis (BV) is the most common cause of vaginitis in women of childbearing age. Women with symptomatic BV may present with malodorous discharge that is off-white, thin, and homogenous and has a fishy smell especially after intercourse. It is of importance to treat women with BV, as this condition is associated with serious risks, such as an increased risk of preterm birth in pregnant women, and particular vulnerability to the acquisition of sexually transmitted disease (STD). The pathophysiology of BV consists of changes in the microbiologic composition of the vaginal flora. The treatment of choice for BV is oral metronidazole for 7 days. Although the available antibiotic therapies produce good results in the short term, symptomatic BV persists or recurs at 3 months in up to 50% to 70% of patients, with long-term recurrence approaching 85%. An alternative treatment option may be a vaginal acid gel which aims to optimize the vaginal milieu. The aim of this pilot study is to assess the efficacy of Gynofit® vaginal gel (lactic acid and glycogen) compared to oral metronidazole in the treatment of BV.


Condition Intervention Phase
Bacterial Vaginosis
Device: Vaginal lactic acid and glycogen gel
Drug: Metronidazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Controlled, Monocentre, Randomized Parallel Group Pilot Study With 2 Treatment Arms in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis (BV)

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Proportion (percentage) of patients with treatment success based on the Amsel criteria at week 3. [ Time Frame: Visit 1 (day 0) and Visit 2 (day 21) ] [ Designated as safety issue: No ]
    This is a binary parameter indicating remission from BV.


Secondary Outcome Measures:
  • Proportion (percentage) of patients with treatment success based on the Nugent score at week 3. [ Time Frame: Visit 1 (day 0) and Visit 2 (day 21) ] [ Designated as safety issue: No ]
    This is a binary parameter indicating remission from BV.

  • Mean symptom score-changes (as pre-post-difference) regarding severity of BV at week 3 [ Time Frame: Visit 1 (day 0) and Visit 2 (day 21) ] [ Designated as safety issue: No ]
    Unpleasant vaginal discharge, unpleasant smell, vaginal pain, itching, burning, dryness

  • Percentage of patients with a complete relief from symptoms [ Time Frame: Visit 1 (day 0), Visit 2 (day 21), Visit 3 (day 84) and Visit 4 (day 252 ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: January 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Gynofit®
Vaginal lactic acid gel
Device: Vaginal lactic acid and glycogen gel
Medical device (registration number: 10-355-717, first licensed 12.08.2010)
Active Comparator: 2: metronidazole
Oral antibiotic
Drug: Metronidazole
Oral antibiotic

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years old
  • Acute symptomatic BV
  • Signed informed consent

Exclusion Criteria

  • Insufficient knowledge of German
  • Illiteracy
  • Pregnancy
  • Acute illness
  • Known allergies against ingredients of the investigational products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042287

Contacts
Contact: Petra Stute, MD 0041316321303 petra.stute@insel.ch
Contact: Juliette Wanner 0041316321370 juliette.wanner@insel.ch

Locations
Switzerland
Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern Not yet recruiting
Berne, Switzerland, 3010
Contact: Petra Stute, MD    0041316321303    petra.stute@insel.ch   
Contact: Juliette Wanner, study nurse    0316321303    juliette.wanner@insel.ch   
Principal Investigator: Petra Stute, M.D.         
Sub-Investigator: Gesa Otti, M.D.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Tentan AG
Investigators
Study Chair: Petra Stute, MD Department of Obstetrics and Gynecology Inselspital Bern
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02042287     History of Changes
Other Study ID Numbers: 026/13
Study First Received: January 20, 2014
Last Updated: January 21, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
Bacterial Infections and Mycoses
Pharmaceutical Preparations
Health Occupations

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Anti-Bacterial Agents
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 01, 2014