A Randomised Controlled Trial of Single Dose Tinidazole+Fluconazole Versus Longer Courses of Metronidazole+Clotrimazole in the Management of West African Women With Vaginal Discharge

NCT00313131 Phase 3 COMPLETED

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

Details

Lead sponsor	Université de Sherbrooke
Phase	Phase 3
Status	COMPLETED
Enrolment	1524
Start date	2004-01
Completion	2005-05

Conditions

• Bacterial Vaginosis
• Candidiasis
• Vaginitis

Interventions

• tinidazole+fluconazole vs metronidazole+clotrimazole

Primary outcomes

• Symptomatic resolution of the vaginal discharge according to the patient

Countries

Ghana, Guinea, Togo