drugset / Trial / NCT07247851

Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole

NCT07247851

Completed 100 enrolled Ain Shams Maternity Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria; this alteration causes offensive smelling vaginal discharge, leading to significant psychological distress and a reduction in quality of life and may be associated with adverse outcomes following a gynecological/obstetrical surgical intervention, such as an increased risk of post-operative infections after pelvic surgery. It has been observed in 29% of reproductive-age individuals in the United States, and the prevalence of BV varies with race and ethnicity

Timeline

Start
2024-01-10
Primary completion
2024-06-01
Completion
2024-06-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clindamycin Unknown 2 % Other
Comparator Metronidazole Small molecule Oral

Indications