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Trial record 23 of 231 for:    clindamycin

Treatment of BV With First Deqularum and Then Direkt After Clindamycin (BV)

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ClinicalTrials.gov Identifier: NCT04067531
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Per-Goran Larsson, Skaraborg Hospital

Brief Summary:
Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.

Condition or disease Intervention/treatment Phase
Infection, Bacterial Drug: treatment of BV with first Deqularum and then direkt after with vaginal clindamycin Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of BV With First Deqularum and Then Direkt After With Vaginal Clindamycin Cream.
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
treatment of BV
all patients be treated with first Deqularum then with clindamycin Cream,
Drug: treatment of BV with first Deqularum and then direkt after with vaginal clindamycin
All patients will get the same treatment




Primary Outcome Measures :
  1. cure of BV [ Time Frame: 6 month ]
    cure rate of BV



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy women with BV

Exclusion Criteria:

  • women treated with antibiotics within 1 month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067531


Contacts
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Contact: P-G Larsson +46500431000 p-g.larsson@vgregion.se

Locations
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Sweden
Department of Ob/Gyn, Skaraborgshospital Skövde Recruiting
Skövde, Sweden, 541 85
Contact: Per-Göran B Larsson, professor    +46500431000    p-g.larsson@vgregion.se   
Contact: Karin Breding, dr    +46500431000    karin.breding@vgregion.se   
Sponsors and Collaborators
Skaraborg Hospital
Investigators
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Principal Investigator: P-G Larsson professor

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Responsible Party: Per-Goran Larsson, professor, Skaraborg Hospital
ClinicalTrials.gov Identifier: NCT04067531     History of Changes
Other Study ID Numbers: 12
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bacterial Infections
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action