Condition category
Infections and Infestations
Date applied
18/06/2007
Date assigned
06/07/2007
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ricardo Ximenes

ORCID ID

Contact details

Universidade Federal de Pernambuco
Departamento de Medicina Tropical
Recife
50670-421
Brazil

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 measures

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

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

http://www.imip.org.br/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes