E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic Vaginitis due to Bacterial Vaginosis, Candidiasis or Trichomoniasis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062167 |
E.1.2 | Term | Vaginitis bacterial |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046950 |
E.1.2 | Term | Vaginitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046958 |
E.1.2 | Term | Vaginitis trichomonal |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048238 |
E.1.2 | Term | Yeast vaginitis |
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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 |
To assess efficacy on: - bacteriological, mycological (candida) and protozoal (Trichomoniasis) infection outcome and on - clinical outcome (symptoms)
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E.2.2 | Secondary objectives of the trial |
To assess safety and tolerability |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Female at least 18 yrs old • With a negative urinary pregnancy test before inclusion in the study, • Practicing a reliable contraception method such as hormonal contraception, intrauterine device, condom or diaphragm • Patients who are able to understand the protocol and have given informed consent • Patients with symptomatic vaginitis: discharge (leucorrhea), itching, burning, irritation, edema, erythema and/or excoriation of the vagina/vulva, painful sexual intercourse (dyspareunia). (Rating: absent = 0; mild = 1; moderate = 2; severe = 3). • With the following findings after saline wet mount and potassium hydroxide (KOH) workup:
For Bacterial Vaginosis: Amsel’s criteria require at least three findings: - Thin homogenous vaginal discharge, - Vaginal secretion pH of >4.5, - Presence of “clue cells" on microscopic examination of the saline “wet mount” - Positive “whiff test”: Fishy odor of the vaginal discharge with the addition of a drop of 10% KOH.
For Candidiasis: - White, creamy, and curdy (cottage cheese-like) vaginal discharge, adherent to the epithelium. - A screening KOH preparation from the inflamed vaginal mucosa reveals yeast forms (hyphae/pseudohyphae) or budding yeasts.
For Trichomoniasis: - Vaginal discharge: copious frothy discharge (white to greenish-yellow) and a raised punctate erythema of the cervix and upper portion of the vagina (strawberry cervix). The discharge is often yellow. Sometimes, it is thick enough to be confused with candidiasis - Positive wet mount: T. vaginalis is an oval- or fusiform-shaped protozoan that, with erratic, twitching motility. A large number of WBCs and epithelial cells are observed. Slides must be read within 20 minutes of obtaining sample due to loss of characteristic motility of the trichomonads. The presence of flagellated, pyriform protozoa indicates a positive result.
In case of mixed infection (e.g.: bacteria and candida) the patient will be allocated to the group with the dominant pattern.
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E.4 | Principal exclusion criteria |
• Patients who are pregnant. A urinary pregnancy test must be performed before inclusion in the study, • Patients who are lactating • Patients with a history of liver or renal dysfunction defined as - AST, ALT more than 3xULN - serum creatinine equal or more than 250 micromol/l • Patients who have other acute gynecological symptoms except for vaginitis (e.g., salpingitis, endometriosis) at the time of screening or admission, • Patients who are unwilling to suspend the use during the study period of other vaginal products such as douches, tampons, spermicides, or herbal preparations, • Patients who have received any other investigational drug within 1 month prior to screening or enrollment, • Serious recent medical condition which makes the patients unsuitable for study participation, • Patients with a concomitant infection that needs an additional antimicrobial agent, • Medical, sociological, or psychological condition which would make the subject unlikely to follow the study protocol, • Inability to undergo repeat treatment, clinical evaluations, and other diagnostic procedures required by the protocol.
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E.5 End points |
E.5.1 | Primary end point(s) |
Bacterial Vaginosis: Clinical Cure defined as complete resolution of the clinical findings (Amsel’s criteria) from the entry visit: • The original discharge characteristic of bacterial vaginosis has returned to a normal physiological discharge which varies in appearance and consistency depending on the menstrual cycle. • The whiff test is negative for any amine (“fishy”) odor • The saline wet mount is negative for clue cells • The pH is <4.7
Candidiasis: Therapeutic Cure: Patient who is considered both clinical cure (complete resolution of signs and symptoms of the vulvovaginal infection) and mycological eradication at Visit 3 (day 21 to 30 of the study).
Trichomoniasis: Therapeutic Cure: Patient who is considered both clinical cure (resolution of trichomoniasis discharge) and protozoal eradication at Visit 3 (day 21 to 30 of the study).
This composite endpoint is made up of • the clinical cure rate and • the mycological / protozoal outcome (eradication or persistence) for candidiasis / trichomoniasis
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |