E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004055 |
E.1.2 | Term | Bacterial vaginosis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 to study the effect of Cleargonal on BV. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to study the safety of Cleargonal used as a multiple-dose vaginal application. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Willing and able to provide informed consent
2) Female
3) Age ≥18 years
4) BV, as defined by the following criteria (Amsel criteria):
a. pH of vaginal fluid greater than 4.5
and at least two of the following criteria:
b. Positive amine test
c. Presence of clue cells
d. Presence of characteristic, homogenous vaginal discharge
5) Regular menstruation cycle
6) Using adequate contraceptive measures |
|
E.4 | Principal exclusion criteria |
1) Hypersensitivity or allergy to the IMP (investigational medical product) or to chemically related products
2) Current use of a copper intrauterine device
3) Currently pregnant or intending to become pregnant within 1 month after treatment
4) Antibiotic treatment within 2 weeks before treatment
5) Signs of infection requiring specific antibiotic treatment
6) Immunosuppression, including HIV1 or 2 infection
7) Vaginal or cervical ulcer or cancer |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Change in Hay/Ison grade between Visit 1 and after the first post-treatment menstruation
• Percentage of patients who show an improvement in Hay/Ison grade from “BV” to “Normal” between Visit 1 and after the first post-treatment menstruation
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the first post-treatment menstruation |
|
E.5.2 | Secondary end point(s) |
• Change in Hay/Ison grade between Visit 1 and the end of the first week post-final treatment
• Change in patient-reported symptoms between Visit 1 and Visit 2
• Change in patient-reported symptoms between Visit 1 and Visit 3
• Change in vaginal pH between Visit 1 and the end of the first week post-final treatment
• Change in vaginal pH between Visit 1 and after the first post-treatment menstruation
• Changes in the vaginal flora during the first week after treatment
• Changes in the vaginal flora between Visit 1 and after the first post-treatment menstruation
• Patient perceptions of treatment
• Number and type of AEs during the study period |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |