None listed
Conditions
Brief summary
To determine if the addition of either topical clindamycin or a topical probiotic/oestrogen combination, reduces recurrent rates of bacterial vaginosis (BV), when added to the current recommended therapy of seven days of the oral antibiotic metronidazole. Hypotheses 1. Combination antibiotic therapy of oral metronidazole with vaginal clindamycin will be more effective than oral metronidazole alone in the treatment of bacterial vaginosis. 2. Restoring normal vaginal acidity and healthy bacteria through replacement of Lactobacillus bacteria and topical oestrogen (in addition to oral metronidazole), will achieve higher rates of cure than current recommended therapy oral metronidazole alone.
Interventions
3 armed trial. All women received 400mg twice daily oral metronidazole for 7 days, and concurrently randomised to also receive either vaginal topical 2% clindamycin cream (1 applicator full once daily for 7 days); vaginal topical probiotic (L.acidophilus KS400)/0.03mg oestriol pessary (one pessary once daily for 12 days) or placebo pessary (one pessary once daily for 12 days).
Sponsors
Bayside Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Women with BV on Nugent's criteria
Exclusion criteria
Pregnant, Human Immunodeficiency Virus (HIV)
Outcome results
None listed