E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10004055 |
E.1.2 | Term | Bacterial vaginosis |
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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 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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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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The end of this study is defined as the date of the last visit of the last patient undergoing this study. (see Protocol section 8. 11) |
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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 |