Back to resultsVaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis
Primary Purpose
Bacterial Vaginosis Treatment
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vaginal Clindamycin Cream
Vaginal Probiotic
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis Treatment
Eligibility Criteria
Inclusion Criteria:
- more than 18 years
- has recurrent Bacterial Vaginosis
Exclusion Criteria:
- pregnancy
- use of other antmicrobial
- not provide informed consent
Sites / Locations
- Zagazig UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic
Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic
Arm Description
Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days
Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use
Outcomes
Primary Outcome Measures
initial cure rate
number of women completely cured
Secondary Outcome Measures
recurrence rate
number of women had recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03234517
Brief Title
Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis
Official Title
Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis
Detailed Description
Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic
Arm Type
Experimental
Arm Description
Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days
Arm Title
Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic
Arm Type
Active Comparator
Arm Description
Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use
Intervention Type
Drug
Intervention Name(s)
Vaginal Clindamycin Cream
Other Intervention Name(s)
dalacin c cream
Intervention Description
Vaginal Clindamycin Cream
Intervention Type
Drug
Intervention Name(s)
Vaginal Probiotic
Other Intervention Name(s)
dicoflor vaginal capsules
Intervention Description
Vaginal Probiotic
Primary Outcome Measure Information:
Title
initial cure rate
Description
number of women completely cured
Time Frame
2 months
Secondary Outcome Measure Information:
Title
recurrence rate
Description
number of women had recurrence
Time Frame
4,6,8and12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
more than 18 years
has recurrent Bacterial Vaginosis
Exclusion Criteria:
pregnancy
use of other antmicrobial
not provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim A EL sharkwy
Phone
00966554818576
Email
ibrahimsharkwy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed L Elsayed
Phone
00201222442467
Email
drmohamedlotfy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim A EL sharkwy
Organizational Affiliation
FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University
City
Zagazig
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis
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