A prospective, placebo-controlled, double-blind study for the investigation of the effect and safety of EcoVag® as adjuvant treatment after treatment with clindamycin against bacterial vaginosis

ISRCTN	ISRCTN62879834
DOI	https://doi.org/10.1186/ISRCTN62879834
Secondary identifying numbers	LA-BV 2003 01

Submission date: 28/03/2007
Registration date: 24/04/2007
Last edited: 05/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Kjeld Rahbek Ryttig
Scientific

Solhoej 13
Nivå
2990
Denmark

Phone	+45 40 73 85 55
Email	kjeld@ryttig.dk

Study information

Study design	A prospective, randomized, placebo-controlled, double-blind trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A prospective, placebo-controlled, double-blind study for the investigation of the effect and safety of EcoVag® as adjuvant treatment after treatment with clindamycin against bacterial vaginosis
Study hypothesis	To assess if adjuvant treatment with EcoVag could increase initial healing and reduce the relapse of bacterial vaginosis.
Ethics approval(s)	Approval received from The National Committees for Research Ethics in Norway (REK soer) on the 4th November 2003.
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	EcoVag
Primary outcome measure	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 study start date	02/02/2004
Overall study end date	02/02/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	100
Total final enrolment	100
Participant inclusion criteria	Non-pregnant female between 18 and 60 years of age with regular menstrual period fulfilling Amsel criteria for bacterial vaginosis
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

Denmark
Norway

Study participating centre

Solhoej 13

Nivå
2990
Denmark

Sponsor information

Bifodan A/S (Denmark)
Industry

Bogbinderivej 6
Hundested
DK-3390
Denmark

Phone	+45 47 98 15 16
Email	erb@bifodan.dk
"ROR"	https://ror.org/05bzbnj80

Funders

Funder type

Industry

Bifodan A/S (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2008	04/01/2021	Yes	No

Editorial Notes

04/01/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.