Metronidazole versus lactic acid for treating bacterial vaginosis

Phase 1

• Conditions: Bacterial Vaginosis; MedDRA version: 20.1Level: PTClassification code 10004055Term: Bacterial vaginosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-004483-19-GB
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-10
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1900

Inclusion Criteria

1.Age 16 years or over.
2.Clinical diagnosis of bacterial vaginosis – based on patient reported symptoms of discharge with an unpleasant (typically fishy) odour (with or without positive microscopy according to local site practice).
3.History of at least one previous episode of bacterial vaginosis within the past two years (clinically diagnosed or patient reported) which resolved with treatment.
4.Willing to use either intravaginal lactic acid gel or oral tablets for the management of BV.
5.Willing to take their own vaginal samples.
6.Willing to avoid vaginal douching during treatment.
7.Willing to provide contact details and be contacted for the purpose of collecting follow-up information.
8.Willing to avoid sexual intercourse or use effective contraception for the 7-day duration of study treatment. (Condoms are not considered to be effective contraception due to a potential interaction with lactic acid gel).
9.Access to the internet, email and willing to complete web based follow up questionnaires in English.
10.Written informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range: 95
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1710
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95

Exclusion Criteria

1.Contra-indications or allergy to lactic acid gel or metronidazole tablets (see section 4.2.1 for details).
2.Pregnant or breastfeeding.
3.Patients currently trying to conceive and not willing to avoid sexual intercourse or use effective contraception for the 7-day duration of study treatment.
4.Use of oral antibiotics (other than the study treatment) or antifungal agents; concurrently, within the last 2 weeks or planned use within the next 2 weeks.
5.Use of topical vaginal antibiotics, antifungals or acidifying products (other than the study treatment); concurrently, within the last 2 weeks, or planned use within the next 2 weeks.
6.Previous participation in this study.
7.Current participation in another clinical trial involving an investigational medicinal product.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified