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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62879834
Enrollment
100
Registered
2007-04-24
Start date
2004-02-02
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis Infections and Infestations Bacterial vaginosis

Interventions

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

Sponsors

Bifodan A/S (Denmark)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026