E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aerobic Bacterial Vaginal Infection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046914 |
E.1.2 | Term | Vaginal infection |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the efficacy of Fluomizin vaginal tablets for the treatment of aerobic bacterial vaginal infections associated with gram-positive cocci (e.g. streptococci, enterococci, and Staphylococcus aureus) and/or gram-negative rods (e.g. pseudomonas, E. coli and other enterobacteria) in comparison to placebo. The primary efficacy variable is the clinical cure rate based on both the Total Symptoms Score (TSC) and the Lactobacillary Grade (LBG). |
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E.2.2 | Secondary objectives of the trial |
The trial should provide additional information on: · The treatment success on short-term and long-term follow-up · The change of physiological status of the vaginal ecosystem during the respective treatments · The assessment of the safety profile of Fluomizin. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Postmenarchal women aged 18 to 50 years which have not yet reached menopause 2. Signs and symptoms of aerobic bacterial vaginal infections, corresponding to a Total Symptoms Score ≤5 (discharge, pruritus, and burning are added using a 4- point scale) 3. Disturbed vaginal microflora with Lactobacillary Grade III 4. Cultural proof of at least one of the associated bacteria, i.e. streptococci, enterococci, S. aureus, pseudomonas, E. coli or other enterobacteria 5. Signed Written Informed Consent |
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E.4 | Principal exclusion criteria |
1. Diagnosis of Bacterial vaginosis and/or presence of clue cells 2. Diagnosis of vulvovaginal candidiasis based on clinical symptoms and/or microscopic examination of the vaginal smear 3. Pregnancy and lactation 4. Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin 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 9. Ulceration of the vulva, vagina or cervix (damaged vaginal surface) 10. Patients receiving 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, Chlamydia trachomatis, Trichomonas vaginalis, Treponema pallidum, Herpes simplex virus type 2, condylomata, human immunodeficiency viruses (HIV) 13. Acute infections of the upper genital tract 14. Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study 15. Patient is relative of or staff directly reporting to the investigator 16. Patient is employee of the sponsor |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical cure defined as a Total Symptoms Score ≤ 1 together with Lactobacillary Grade = I at C2 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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see protocol section 8.11 The end of this study is defined as the date of the last visit of the last patient undergoing this study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |