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 |
| Protocol serial number | LA-BV 2003 01 |
| Sponsor | Bifodan A/S (Denmark) |
| Funder | Bifodan A/S (Denmark) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Kjeld Rahbek Ryttig
Scientific
Scientific
Solhoej 13
Nivå
2990
Denmark
| Phone | +45 40 73 85 55 |
|---|---|
| kjeld@ryttig.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A prospective, randomized, placebo-controlled, double-blind trial. |
| Secondary study design | Randomised controlled trial |
| 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 objectives | 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. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | EcoVag |
| Primary outcome measure(s) |
Time from healing to relapse of symptoms, measured after one month, three and six months after treatment. |
| Key secondary outcome measure(s) |
Number of patients initially healed, measured after one month, three and six months after treatment. |
| Completion date | 02/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | Non-pregnant female between 18 and 60 years of age with regular menstrual period fulfilling Amsel criteria for bacterial vaginosis |
| Key exclusion criteria | 1. Ongoing infection with candida albicans or clamydia trachomatis 2. Participating in another drug study within the last 6 weeks |
| Date of first enrolment | 02/02/2004 |
| Date of final enrolment | 02/02/2006 |
Locations
Countries of recruitment
- Denmark
- Norway
Study participating centre
Solhoej 13
Nivå
2990
Denmark
2990
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
