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Vaginal colonization of the LN bacteria (patented human lactic acid producing bacteria) when conventional treatment of bacterial vaginosis and Candida vaginitis is followed by treatment with Vagipills®. - KI DS 200509

Vaginal colonization of the LN bacteria (patented human lactic acid producing bacteria) when conventional treatment of bacterial vaginosis and Candida vaginitis is followed by treatment with Vagipills®. - KI DS 200509

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004890-10-SE
Enrollment
100
Registered
2005-11-01
Start date
2006-02-17
Completion date
Unknown
Last updated
2020-04-06

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

Conditions

Diagnosed Bacterial Vaginosis (BV) or Candida Vaginitis(CV) ICD: N76.8 (BV)

Interventions

Product Name: Vagipills Pharmaceutical Form: Capsule* Current Sponsor code: LN-bacteria Other descriptive name: Strains of lactic acid producing bacteria of human vaginal origin Concentration type: ra

Sponsors

Kvinnokliniken
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Signed informed consent Woman 18-45 years old Diagnosed bacterial vaginosis or Candida vaginitis At least 8 days until first day of next menstruation 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) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy Breast feeding Pelvic inflammatory disease Sexually transmitted disease (STD) (e.g. Chlamydia trachomatis) Allergy to clindamycine or clotrimazole Concomitant medication with: -antibiotics/antimycotics for other diagnoses -natural remedies e.g. tea tree oil Concomitant participation in another clinical trial Previous participation in this study

Design outcomes

Primary

MeasureTime frame
Main Objective: To study the colonising potential of specific lactic acid producing bacteria strains after vaginal administration.;Secondary Objective: To investigate: • the effect on pH in vagina, • clinical symptoms (patient ratings) • clinical symptoms (Amsel criteria) • record any relevant adverse events (AE) during the study period. ;Primary end point(s): Colonisation potential of specfic lactic acid producing bacteria strains at various time points after the administration.—

Countries

Sweden

Outcome results

None listed

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