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

NCT02042287 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-04-08

No results posted yet for this study

Summary

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.

Conditions

  • Bacterial Vaginosis

Interventions

DEVICE

Vaginal lactic acid and glycogen gel

Medical device (registration number: 10-355-717, first licensed 12.08.2010)

DRUG

Metronidazole

Oral antibiotic

Sponsors & Collaborators

  • Tentan AG

    collaborator UNKNOWN

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Petra Stute, MD · Department of Obstetrics and Gynecology Inselspital Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2020-03-19
Completion
2020-03-19

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02042287 on ClinicalTrials.gov