Bacterial vaginosis (Nugent score 4 or above)
Conditions
Interventions
Trade Name: Gynevac suspension for injection
Product Name: Gynevac
Product Code: NA
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of ad
Sponsors
Amvac Kft
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years or above 2. Mentally competent 3. Written informed consent 4. Being able to comply with the protocol 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 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to formaldehyde, or any other of the components of Gynevac 2. Fever 3. Acute infectious disease 4. Immunosuppression 5. Acute polyarthritis 6. Serious cardiac, liver or kidney diseases 7. Abnormalities of the blood circulation or of the hemopoetic system 8. Ongoing antibiotic treatment 9. Use of any investigational drug within 30 days of V0 10. No former antibiotic treatment for any reasons in 14 days before study entry
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): vaginal pH change, ;Timepoint(s) of evaluation of this end point: 63 days | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the efficacy and safety of a 5-shot treatment period with lactobacilli vaccination in patients with bacterial vaginosis and gathering information about dosage regimen;Secondary Objective: Secondary endpoint is the change of vaginal pH during the treatment period. Other secondary endpoints are the patients subjective evaluation and changes in IgA levels (Microbe specific immunoglobulin answer) ;Primary end point(s): Nugent score changes in Vaginal smear;Timepoint(s) of evaluation of this end point: 63 days | — |
Countries
Hungary
Contacts
Public ContactAmvac Kft
Amvac Kft
Outcome results
None listed