Bacterial Vaginosis MedDRA version: 8.1 Level: LLT Classification code 10004055 Term: Bacterial vaginosis
Conditions
Sponsors
Medinova AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Postmenarchal women aged 18 to 55 years which have not yet reached menopause 2. Diagnosis of bacterial vaginosis (all 4 Amsel criteria must be positive) 3. Patients of child bearing potential must be using a highly effective form of birth control such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or have a vasectomized partner – excluded are methods that involve materials sensitive to mineral oil, like condoms, diaphragms 4. Signed Written Informed Consent to participate in this study 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: 1. Pregnancy or lactation 2. Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin 3. Acute infections of the upper genital tract 4. Clinical Symptoms of a vulvovaginal Candidiasis 5. Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study 6. Use of any vaginal medication in the previous 7 days 7. Use of vaginal douches, particularly containing soaps and other anionic, surface-active substances, in the previous 48 hours and/or during the entire duration of the trial 8. Known or suspected hypersensitivity to one of the study medications, inclusive their excipients, or Lincomycin 9. Ulceration of the vulva, vagina or cervix (damaged vaginal surface) 10. Patients receiving systemic immunosuppressive therapy or who have immune system deficiency 11. Malignant tumours in the genital tract 12. Suspicion of or clinically manifest Sexually Transmitted Diseases (STDs), i.e: Neisseria gonorrhoea, Trichomonas vaginalis, Treponema pallidum, Herpes simplex virus type 2, condylomata, human immunodeficiency viruses (HIV) 13. Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study. 14. Parallel use of Erythromycin 15. Regional enteritis, ulcerative colitis or medical history of antibiotics-induced colitis 16. Patient is relatives of, or staff directly reporting to, the investigator 17. Patient is employee of the sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the assessment of clinical cure rate based on the Amsel criteria (vaginal pH > 4.5, presence of clue cells, KOH test as well as greyish white, malodorous discharge), where clinical cure is defined as: clue cells and 2 other criteria must be negative.;Secondary Objective: 1) Assessment of differences among treatments on short- and long-term follow-up 2) Assessment of the physiological status of the vaginal ecosystem during the respective treatments 3) Assessment of safety profile of Fluomizin;Primary end point(s): Clinical cure rate based on the Amsel criteria (vaginal pH > 4.5, presence of clue cells, KOH test, greyish white, malodorous discharge), where clinical cure is defined as: clue cells and 2 other criteria must be negative at visit C1 | — |
Countries
Austria, Czech Republic, Germany
Outcome results
None listed