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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000063-28-DE

Enrollment

Registered

2006-03-03

Start date

2006-05-09

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

antisepsis of genital mucous membranes

Interventions

Product Name: Stellisept mucosa Product Code: VP 514 Pharmaceutical Form: Cutaneous solution INN or Proposed INN: [N.N'-(Decan-(1,10decandiyldi-1[4H]-pyridinyl-4-ylidene)bis(1octanamide)dihydrochlorid

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - age under 18 or over 65 - pregnancy or lactating mother

Design outcomes

Primary

Measure	Time frame
Main Objective: demonstrate antiseptic efficacy of product;Secondary Objective: demonstrate local tolerability of product;Primary end point(s): antiseptic efficacy (reduction of bacterial load)	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026