Treatment of Bacterial Vaginosis Combined With Human Lactobacilli
Extended Antimicrobial Treatment of Bacterial Vaginosis Combined With Human Lactobacilli to Find the Best Treatment and Minimize the Risk of Relapses
1 other identifier
interventional
75
1 country
1
Brief Summary
The primary objectives of this study were to characterize lactobacilli of human vaginal origin and to investigate if more extended antibiotic treatment against Bacterial Vaginosis, together with adjuvant lactobacilli treatment, could increase the cure rate and furthermore, to investigate factors that could influence relapse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 19, 2010
CompletedFirst Posted
Study publicly available on registry
November 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 10, 2014
November 1, 2014
7.8 years
November 19, 2010
November 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
characterize lactobacilli of human vaginal origin
characterize lactobacilli of human vaginal origin
24 month
Secondary Outcomes (1)
cure rate after 24 month
24 month
Study Arms (1)
Lactobacilli
ACTIVE COMPARATORdifferent lactobacilli.
Interventions
women were given a seven days course of daily 2% vaginal clindamycin cream (Dalacin vaginal cream 2%, Pfizer Norway Ltd) together with oral clindamycin 300 mg BID for 7 days (Dalacin 300 mg, Pfizer Norway Ltd). Oral clindamycin treatment was also given to the patient's sexual partner.
Eligibility Criteria
You may qualify if:
- were regularly menstruating women, 18 years or older, with normal gynaecological status, not pregnant or breast-feeding and without signs of other genital tract infections.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skaraborg Hospitallead
- Karolinska University Hospitalcollaborator
Study Sites (1)
Gynekologklinikken
Drammen, 3002, Norway
Related Publications (1)
Larsson PG, Brandsborg E, Forsum U, Pendharkar S, Andersen KK, Nasic S, Hammarstrom L, Marcotte H. Extended antimicrobial treatment of bacterial vaginosis combined with human lactobacilli to find the best treatment and minimize the risk of relapses. BMC Infect Dis. 2011 Aug 19;11:223. doi: 10.1186/1471-2334-11-223.
PMID: 21854593DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per-Göran Larsson, professor
Skaraborg hospital and University College of Skövde, SE-541 85 Skövde, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 19, 2010
First Posted
November 22, 2010
Study Start
January 1, 2007
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 10, 2014
Record last verified: 2014-11