E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unspecific and mixed vulvovaginal infections characterized by vaginal discharge. |
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E.1.1.1 | Medical condition in easily understood language |
Unspecific and mixed vulvovaginal infections characterized by vaginal discharge. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
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 the study is to evaluate the clinical effectiveness of Geonistin vaginal tablets administered in empirical treatment of female adult patients with unspecific and mixed vulvovaginal infections characterized by vaginal discharge (pathological and/or unusual).. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are as follows: To assess systemic exposure to oxytetracycline following local treatment of vulvovaginal infections with Geonistin vaginal tablets; Cure rate according to the Nugent score (where applicable); Microbiology results (outcome); to evaluate safety of Geonistin vaginal tablets. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Unspecific and mixed vulvovaginal infections characterized by vaginal discharge (pathological and/or unusual) and at least one additional sign/symptom.
2. Women of reproductive age, who are ≥18 years of age.
3. Lactobacillary grade ≥2 in vaginal exam.
4. According to investigator’s judgment the patients should receive local treatment only.
5. Signed informed consent.
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E.4 | Principal exclusion criteria |
a. Trichomonas vaginalis infection (detected by wet preparation of vaginal smear or confirmed by OSOM® rapid test).
b. Neisseria gonorrhea infection (clinically suspected).
c. Chlamydia trachomatis infection (clinically suspected).
d. Infection with Herpes simplex virus (clinically suspected).
e. Patients with other vaginal or vulvar condition, which would confound the interpretation of clinical response.
f. Women with cervical carcinoma.
g. Women under treatment for cervical intraepithelial neoplasia (CIN).
h. Recurrent BV (three or more episodes of BV in 12 months).
i. Recurrent VVC (four or more VVC episodes in 12 months).
j. Use of a topical or systemic antimicrobial treatment within 30 days before the study.
k. On-going immunosuppressant treatment.
l. On-going systemic antimicrobial therapy.
m. On-going use of vaginal probiotics (oral and vaginal
capsules, and all other form
which helps regeneration of
vaginal flora).
n. Women currently menstruating or expecting menstruation within 1 week.
o. Women using an intrauterine contraceptive device.
p. Pregnancy (excluded by pregnancy urine test).
q. Lactation.
r. Patients who gave birth or underwent gynecological surgery within 2 months before the study.
s. History of allergic reactions to nystatin or oxytetracycline or to excipients of the pharmaceutical product.
t. Participation in another clinical study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical cure rate after 6 days of treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Clinical effectiveness of 6 day treatment with Geonistin vaginal tablets in empirical treatment of vulvovaginal infections at day 13±2. |
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E.5.2 | Secondary end point(s) |
Trough steady-state serum concentrations of oxytetracycline, Cure rate according to the Nugent score (where applicable), Microbiological cure rate, Safety evaluation. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 days after the start of treatment. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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
| 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 | 16 |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |