Back to resultsTreatment of BV With First Deqularum and Then Direkt After Clindamycin (BV)
Primary Purpose
Infection, Bacterial
Status
Unknown status
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
treatment of BV with first Deqularum and then direkt after with vaginal clindamycin
Sponsored by
About this trial
This is an interventional treatment trial for Infection, Bacterial
Eligibility Criteria
Inclusion Criteria:
- healthy women with BV
Exclusion Criteria:
- women treated with antibiotics within 1 month
Sites / Locations
- Department of Ob/Gyn, Skaraborgshospital SkövdeRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
treatment of BV
Arm Description
all patients be treated with first Deqularum then with clindamycin Cream,
Outcomes
Primary Outcome Measures
cure of BV
cure rate of BV
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04067531
Brief Title
Treatment of BV With First Deqularum and Then Direkt After Clindamycin
Acronym
BV
Official Title
Treatment of BV With First Deqularum and Then Direkt After With Vaginal Clindamycin Cream.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skaraborg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.
Detailed Description
The hypoteses is that deqularum cloride takes away the biofilm so that clindamycin will kills the bacteria.
Cure rate will be followed up after 1 month and then after 6 month
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Bacterial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment of BV
Arm Type
Other
Arm Description
all patients be treated with first Deqularum then with clindamycin Cream,
Intervention Type
Drug
Intervention Name(s)
treatment of BV with first Deqularum and then direkt after with vaginal clindamycin
Intervention Description
All patients will get the same treatment
Primary Outcome Measure Information:
Title
cure of BV
Description
cure rate of BV
Time Frame
6 month
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
healthy women with BV
Exclusion Criteria:
women treated with antibiotics within 1 month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
P-G Larsson
Phone
+46500431000
Email
p-g.larsson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P-G Larsson
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ob/Gyn, Skaraborgshospital Skövde
City
Skövde
ZIP/Postal Code
541 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per-Göran B Larsson, professor
Phone
+46500431000
Email
p-g.larsson@vgregion.se
First Name & Middle Initial & Last Name & Degree
Karin Breding, dr
Phone
+46500431000
Email
karin.breding@vgregion.se
12. IPD Sharing Statement
Learn more about this trial
Treatment of BV With First Deqularum and Then Direkt After Clindamycin
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