- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067531
Treatment of BV With First Deqularum and Then Direkt After Clindamycin (BV)
October 24, 2020 updated by: Per-Goran Larsson, Skaraborg Hospital
Treatment of BV With First Deqularum and Then Direkt After With Vaginal Clindamycin Cream.
Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: P-G Larsson
- Phone Number: +46500431000
- Email: p-g.larsson@vgregion.se
Study Locations
-
-
-
Skövde, Sweden, 541 85
- Recruiting
- Department of Ob/Gyn, Skaraborgshospital Skövde
-
Contact:
- Per-Göran B Larsson, professor
- Phone Number: +46500431000
- Email: p-g.larsson@vgregion.se
-
Contact:
- Karin Breding, dr
- Phone Number: +46500431000
- Email: karin.breding@vgregion.se
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- healthy women with BV
Exclusion Criteria:
- women treated with antibiotics within 1 month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: treatment of BV
all patients be treated with first Deqularum then with clindamycin Cream,
|
All patients will get the same treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cure of BV
Time Frame: 6 month
|
cure rate of BV
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: P-G Larsson, Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2020
Primary Completion (ANTICIPATED)
August 1, 2021
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 22, 2019
First Posted (ACTUAL)
August 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 24, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12 (Israel lung Association)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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