BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost
patients time, energy, comfort and money. BV is associated with increased incidence of
sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour,
post-surgical infections, and endometritis. Current treatment for those women symptomatic for
BV includes both oral and intravaginal antibiotics, such as metronidazole, which have success
rates of 70-80 % at 1 month after treatment. These treatments also have high recurrence rates
(49-66 % at one year after treatment) and side effects (10-20 % of women) that include
secondary vaginal infection with candida. Intravaginal boric acid has been used for >100
years for the treatment of vaginal infections and is quite commonly prescribed today as a
treatment for BV. It is cheap, easily accessible, easy to use, and is an effective treatment
of other vaginal infections, such as candida. To date, there are no clinical trials studying
the effectiveness of boric acid in the treatment of BV.
The objective of this study was to determine whether intravaginal BA is comparable to
standard treatment, metronidazole, for the cure of BV in symptomatic women.
Our research question is: Among women 16-50 years old symptomatic with BV is intravaginal
treatment with BA non-inferior to metronidazole to achieve a Nugent score <7 (cure) by day
17.
Hypothesis: H0: BA proportion of women cured < metronidazole proportion of women cured - 10%.