Condition category
Infections and Infestations
Date applied
28/03/2007
Date assigned
24/04/2007
Last edited
27/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kjeld Rahbek Ryttig

ORCID ID

Contact details

Solhoej 13
Nivå
2990
Denmark
+45 40 73 85 55
kjeld@ryttig.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LA-BV 2003 01

Study information

Scientific title

Acronym

Study hypothesis

To assess if adjuvant treatment with EcoVag could increase initial healing and reduce the relapse of bacterial vaginosis.

Ethics approval

Approval received from The National Committees for Research Ethics in Norway (REK soer) on the 4th November 2003.

Study design

A prospective, randomized, placebo-controlled, double-blind trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Bacterial vaginosis

Intervention

Intervention group:
Clindamycin (7 days) and EcoVag for four menstrual periods. EcoVag was administered for 5 to 10 days in the first menstrual period and for 10 days during each of the subsequent 3 periods.

Control group:
Clindamycin (7 days) and placebo for four menstrual periods. Placebo was administered for 5 to 10 days in the first menstrual period and for 10 days during each of the subsequent 3 periods.

Intervention type

Drug

Phase

Not Specified

Drug names

EcoVag

Primary outcome measures

Time from healing to relapse of symptoms, measured after one month, three and six months after treatment.

Secondary outcome measures

Number of patients initially healed, measured after one month, three and six months after treatment.

Overall trial start date

02/02/2004

Overall trial end date

02/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Non-pregnant female between 18 and 60 years of age with regular menstrual period fulfilling Amsel criteria for bacterial vaginosis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Ongoing infection with candida albicans or clamydia trachomatis
2. Participating in another drug study within the last 6 weeks

Recruitment start date

02/02/2004

Recruitment end date

02/02/2006

Locations

Countries of recruitment

Norway

Trial participating centre

Solhoej 13
Nivå
2990
Denmark

Sponsor information

Organisation

Bifodan A/S (Denmark)

Sponsor details

Bogbinderivej 6
Hundested
DK-3390
Denmark
+45 47 98 15 16
erb@bifodan.dk

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Bifodan A/S (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes