The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis
NCT ID: NCT03080740
Last Updated: 2017-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2016-07-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Clindamycin palmitate hydrochloride
Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days
Clindamycin palmitate hydrochloride dispersible tablet
300mg, oral after meal, twice daily, a total of 7days
Metronidazole
Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days
Metronidazole Tablet
400mg, oral after meal , twice daily, a total of 7days
Interventions
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Clindamycin palmitate hydrochloride dispersible tablet
300mg, oral after meal, twice daily, a total of 7days
Metronidazole Tablet
400mg, oral after meal , twice daily, a total of 7days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female patients aged 18 to 55 years old.
3. Patients signed the Informed Consent Form(ICF).
Exclusion Criteria
2. Patients received systemic or vaginal antimicrobial therapy in a week before enrolled.
3. Patients with other vaginal or vulvar disorders which could effect the evaluation of efficacy.
4. Pregnant or lactating patients.
5. Menopausal women.
Menopause definition: perimenopausal women stop menstruations for a year.
6. Women with diabetes.
7. Dependent on alcohol and could not prohibit during the study period.
8. Women with liver and kidney disfunction, blood disorders, mental illness or other serious diseases.
9. Women allergic to metronidazole, clindamycin.
10. With poor compliance.
18 Years
55 Years
FEMALE
No
Sponsors
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Guangzhou Yipinhong Pharmaceutical CO.,LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Zhaohui Liu, MD
Role: STUDY_CHAIR
Peking University First Hospital
Shangrong Fan, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Shenzhen Hospital
Long Sui, MD
Role: PRINCIPAL_INVESTIGATOR
Affiliated Gynecology and Obstetrics Hospital of Fudan University
Ruifang An, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Xi 'an Jiaotong University
Locations
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Peking University first hospital
Beijing, , China
Countries
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Central Contacts
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Dai Zhang, MD
Role: CONTACT
Facility Contacts
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Zhaohui Liu, MD
Role: primary
Other Identifiers
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YPH-BV
Identifier Type: -
Identifier Source: org_study_id
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