Dequalinium versus usual care antibiotics for the treatment of 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: EUCTR2019-002819-25-GB
• Lead Sponsor: eeds Teaching Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-19
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: 904

Inclusion Criteria

1. Cis-Women aged 16 years and over
2. Diagnosis of BV confirmed by on-site microscopy (Ison-Hay Grade 3) with symptoms of vaginal odour plus or minus vaginal discharge requiring treatment with usual care (BV guideline recommended) antibiotics
3. Willing to use either intravaginal dequalinium chloride tablets (pessaries) or the clinician selected usual care antibiotic BV treatment
4. Willing to avoid vaginal sex whilst taking/using trial treatment
5. Willing to avoid vaginal douching whilst taking/using trial treatment
6. Willing to complete follow up questionnaires in English
7. Written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 864
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

a. Contra-indications or allergy to dequalinium chloride or clinician selected usual care antibiotic BV treatment
b. Use of oral antibiotics concurrently, within the past 14 days or planned use over the next 14 days.
c. Use of intravaginal therapies (including vaginal douching) concurrently, within the past 14 days or planned use over the next 14 days.
d. Diagnosis of any infection at the baseline visit that requires immediate antibiotic treatment
e. Pregnant women who are seeking a termination
f. Unwilling to provide GP information (only to be used for pregnant women or women who become pregnant in the first 4 weeks of the trial)
g. Previous participation in this trial

Study & Design

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