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Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments

NCT00313131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1524

Last updated 2006-04-11

No results posted yet for this study

Summary

This randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge in primary health care centers of Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done under conditions typical of routine work in these health centers

Conditions

  • Bacterial Vaginosis
  • Candidiasis
  • Vaginitis

Interventions

DRUG

tinidazole+fluconazole vs metronidazole+clotrimazole

Sponsors & Collaborators

  • Canadian International Development Agency

    collaborator OTHER_GOV

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Jacques Pepin, MD · U of Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2005-05-31

Countries

  • Ghana
  • Guinea
  • Togo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00313131 on ClinicalTrials.gov