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

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

Study Locations

      • Skövde, Sweden, 541 85
        • Recruiting
        • Department of Ob/Gyn, Skaraborgshospital Skövde
        • Contact:
        • Contact:

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.

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

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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