Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole
NCT07247851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-11-25
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
Conditions
- Bacterial Vaginosis
Interventions
- DRUG
-
Clindamycin Phosphate
comparing the efficacy of the combined use of vaginal clindamycin cream and oral metronidazole in comparison to oral metronidazole alone for bacterial vaginosis treatment.
Sponsors & Collaborators
-
Ain Shams Maternity Hospital
lead OTHER
Principal Investigators
-
Laila Aly Farid, Professor · Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-10
- Primary Completion
- 2024-06-01
- Completion
- 2024-06-10
Countries
- Egypt
Study Locations
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