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
- Conditions
- Diagnosed Bacterial Vaginosis (BV) or Candida Vaginitis(CV)ICD: N76.8 (BV)N77.1*B37.3+(CV)
- Registration Number
- EUCTR2005-004890-10-SE
- Lead Sponsor
- Kvinnokliniken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the colonising potential of specific lactic acid producing bacteria strains after vaginal administration.;Secondary Objective: To investigate:<br>•the effect on pH in vagina,<br>•clinical symptoms (patient ratings)<br>•clinical symptoms (Amsel criteria)<br>•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.
- Secondary Outcome Measures
Name Time Method