A monocentric, double-blind, randomized phase III clinical study to investigate the antimicrobial efficacy and local tolerability of an antiseptic (Stellisept mucosa, containing 0.1 % octenidine dihydrochloride) after a single application at the genital mucosa in comparison to a reference product (Octenisept®) in a panel of 44 healthy male and female volunteer
- Conditions
- antisepsis of genital mucous membranes
- Registration Number
- EUCTR2006-000063-28-DE
- Lead Sponsor
- BODE Chemie GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- male and female healthy volunteers
- 18-65 years of age
- informed consent
- negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- age under 18 or over 65
- pregnancy or lactating mother
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: demonstrate antiseptic efficacy of product;Secondary Objective: demonstrate local tolerability of product;Primary end point(s): antiseptic efficacy (reduction of bacterial load)
- Secondary Outcome Measures
Name Time Method