Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections
NCT01697826 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2012-10-02
Summary
Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective vaginitis.
Conditions
- Vaginal Infections
Interventions
- DRUG
-
ClinSupV3 -soft gelatin capsule
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole
- DRUG
-
ClinSupV3ER- Extended release tablet
3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole
Sponsors & Collaborators
-
Resilient Cosmeceuticals Pvt. Ltd, Pune
collaborator UNKNOWN -
Dr Bharti Daswani
lead INDIV
Principal Investigators
-
Bharti R Daswani, MD, PhD · BJ Govt Medical College & Sassoon General Hospitals, Pune
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2011-09-30
- Completion
- 2011-09-30
Countries
- India
Study Locations
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