Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clindamycin | Unknown | 2 % | Other |
| Comparator | Metronidazole | Small molecule | — | Oral |