The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis
NCT03080740 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2017-03-15
Summary
Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis
Conditions
- Bacterial Vaginosis
Interventions
- DRUG
-
Clindamycin palmitate hydrochloride dispersible tablet
300mg, oral after meal, twice daily, a total of 7days
- DRUG
-
Metronidazole Tablet
400mg, oral after meal , twice daily, a total of 7days
Sponsors & Collaborators
-
Guangzhou Yipinhong Pharmaceutical CO.,LTD
lead INDUSTRY
Principal Investigators
-
Zhaohui Liu, MD · Peking University First Hospital
-
Shangrong Fan, MD · Peking University Shenzhen Hospital
-
Long Sui, MD · Affiliated Gynecology and Obstetrics Hospital of Fudan University
-
Ruifang An, MD · First Affiliated Hospital of Xi 'an Jiaotong University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2017-07-31
- Completion
- 2017-12-31
Countries
- China
Study Locations
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