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

NCT02042287 | Completed Phase 4

• 1 other identifier: 026/13
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bacterial Infections and Mycoses; Pharmaceutical Preparations; Health Occupations

Outcome Measures

Primary Outcomes (1)

• Proportion (percentage) of patients with treatment success based on the Amsel criteria at week 3.

  This is a binary parameter indicating remission from BV.

  Visit 1 (day 0) and Visit 2 (day 21)

Secondary Outcomes (3)

• Proportion (percentage) of patients with treatment success based on the Nugent score at week 3.

  Visit 1 (day 0) and Visit 2 (day 21)

• Mean symptom score-changes (as pre-post-difference) regarding severity of BV at week 3

  Visit 1 (day 0) and Visit 2 (day 21)

• Percentage of patients with a complete relief from symptoms

  Visit 1 (day 0), Visit 2 (day 21), Visit 3 (day 84) and Visit 4 (day 252

Study Arms (2)

1: Gynofit®

EXPERIMENTAL

Vaginal lactic acid gel

Device: Vaginal lactic acid and glycogen gel

2: metronidazole

ACTIVE COMPARATOR

Oral antibiotic

Drug: Metronidazole

Interventions

Vaginal lactic acid and glycogen gel DEVICE

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

1: Gynofit®

Metronidazole DRUG

Oral antibiotic

2: metronidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Insufficient knowledge of German
• Illiteracy
• Pregnancy
• Acute illness
• Known allergies against ingredients of the investigational products

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Tentan AG: collaborator

Study Sites (1)

Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern

Bern, 3010, Switzerland

Location

Related Publications (8)

• Schwebke JR. Gynecologic consequences of bacterial vaginosis. Obstet Gynecol Clin North Am. 2003 Dec;30(4):685-94. doi: 10.1016/s0889-8545(03)00086-x.

  PMID: 14719845 BACKGROUND

• Hill GB. The microbiology of bacterial vaginosis. Am J Obstet Gynecol. 1993 Aug;169(2 Pt 2):450-4. doi: 10.1016/0002-9378(93)90339-k.

  PMID: 8357043 BACKGROUND

• Saunders S, Bocking A, Challis J, Reid G. Effect of Lactobacillus challenge on Gardnerella vaginalis biofilms. Colloids Surf B Biointerfaces. 2007 Apr 1;55(2):138-42. doi: 10.1016/j.colsurfb.2006.11.040. Epub 2006 Dec 9.

  PMID: 17234391 BACKGROUND

• Wilson JD, Shann SM, Brady SK, Mammen-Tobin AG, Evans AL, Lee RA. Recurrent bacterial vaginosis: the use of maintenance acidic vaginal gel following treatment. Int J STD AIDS. 2005 Nov;16(11):736-8. doi: 10.1258/095646205774763081.

  PMID: 16303068 RESULT

• Andersch B, Forssman L, Lincoln K, Torstensson P. Treatment of bacterial vaginosis with an acid cream: a comparison between the effect of lactate-gel and metronidazole. Gynecol Obstet Invest. 1986;21(1):19-25. doi: 10.1159/000298923.

  PMID: 3485071 RESULT

• Holley RL, Richter HE, Varner RE, Pair L, Schwebke JR. A randomized, double-blind clinical trial of vaginal acidification versus placebo for the treatment of symptomatic bacterial vaginosis. Sex Transm Dis. 2004 Apr;31(4):236-8. doi: 10.1097/01.olq.0000118423.20985.e7.

  PMID: 15028938 RESULT

• Boeke AJ, Dekker JH, van Eijk JT, Kostense PJ, Bezemer PD. Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial. Genitourin Med. 1993 Oct;69(5):388-92. doi: 10.1136/sti.69.5.388.

  PMID: 8244360 RESULT

• Tidbury F, Brulhart G, Muller G, Pavicic E, Weidlinger S, Eichner G, von Wolff M, Stute P. Effectiveness and tolerability of lactic acid vaginal gel compared to oral metronidazole in the treatment of acute symptomatic bacterial vaginosis: a multicenter, randomized-controlled, head-to-head pilot study. BMC Womens Health. 2025 Jan 6;25(1):7. doi: 10.1186/s12905-024-03513-1.

  PMID: 39762879 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial; Bacterial Infections and Mycoses

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Petra Stute, MD

  Department of Obstetrics and Gynecology Inselspital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 22, 2014
• Study Start: June 1, 2014
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

CH (1)