Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Bacterial vaginosis is a polymicrobial clinical syndrome where the Lactobacillus are replaced by anaerobic bacteria, Gardnerela vaginalis and Mycoplasma hominis.
The study hypothesis is that metronidazole and aroeira have similar efficacy in the treatment of bacterial vaginosis, but aroeira has less impact in the vaginal flora, because it is a natural substance, extracted from a tree caulis.
Ethics approval
Ethical Commitee in Research of the Instituto Materno Infantil (c/o Prof Fernando Figueira) approved in March 2007.
Study design
Randomised double-blind controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Bacterial vaginosis
Intervention
The participants will be randomised into two groups of 150 women:
Control group: Metronidazole gel 0.75%, intravaginally, once a day for seven days.
Intervention group: Schinus terebinthifolius Raddi (aroeira) gel 3,996 ml/6 g, intravaginally, once a day for seven days.
Intervention type
Drug
Phase
Not Specified
Drug names
Metronidazole, Shinus terebinthifolius Raddi (called aroeira)
Primary outcome measure
To compare the frequency of the clinical (Amsel Criteria) and bacteriological (Nugent criteria) cure assessed at baseline and after their next menses (approximately one month after therapy) between the two groups.
Secondary outcome measures
1. To compare the frequencies of the adverse effects of the two drugs
2. To compare the frequencies of the effects in the vaginal flora, observing the presence of lactobacillus in Papanicolaou smears at baseline and after their next menses (approximately one month after therapy)
3. To compare the frequencies of the effects of the two treatments by the presence of bacterias and fungi in vaginal cultures at baseline and after their next menses (approximately one month after therapy)
Overall trial start date
20/06/2007
Overall trial end date
20/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged between 18 and 40 years
2. Women with vaginal discharge caused by bacterial vaginosis, diagnosed using the Amsel (clinical) and Nugent (Gram stein) criteria
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300 women
Participant exclusion criteria
1. Pregnant women
2. Women using antibiotics for other infections in the last 30 days
3. Women using any other vaginal treatment in the last 30 days
4. Women who have never had sexual intercourse
5. Women with other vaginal infections such as candidiasis or trichomoniasis
6. Women with a suggestive diagnosis of pelvic inflammatory disease
Recruitment start date
20/06/2007
Recruitment end date
20/06/2008
Locations
Countries of recruitment
Brazil
Trial participating centre
Universidade Federal de Pernambuco
Recife
50670-421
Brazil
Sponsor information
Organisation
Institute for Maternal/Infant Health (IMIP) (Brazil)
Sponsor details
Rua dos Coelhos
300 - Boa Vista
Recife
50070-550
Brazil
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
The vaginal treatments will be provided by Laboratório Hebron (www.hebron.com.br) (Brazil). The assessments will be carried out at the Instituto Materno Infantil (Brazil) - c/o Prof Fernando Figueira, where the study will take place.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list