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| ID | Type | Description | Link |
|---|---|---|---|
| CRO-PK-14-289 | Other Identifier | CROSS Research S.A., Phase I Unit |
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| Name | Class |
|---|---|
| Cross Research S.A. | INDUSTRY |
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The primary objective of the study is to evaluate local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and repeated applications once a day for 15 days, safety of the investigational products and comfort of use will also be evaluated as secondary objectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Econazole nitrate 1% plus Benzydamine HCl 0.12% | Experimental | 5 grams of Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days |
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| Placebo plus Econazole nitrate 1% | Active Comparator | 5 grams of Placebo plus Econazole nitrate 1% intravaginal cream, once daily for 15 consecutive days |
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| Placebo plus Benzydamine HCl 0.12% | Active Comparator | 5 grams of Placebo plus Benzydamine HCl 0.12% intravaginal cream, once daily for 15 consecutive days. |
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| Placebo | Placebo Comparator | 5 grams of Placebo intravaginal cream, once daily for 15 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream | Drug |
| ||
| Placebo plus Econazole nitrate 1% intravaginal cream |
| Measure | Description | Time Frame |
|---|---|---|
| Local Adverse Events (AEs) | Occurrence of local Adverse Events (AEs) reported in the subject's diary as 1-3 scores for pruritus, burning sensation, pain, stinging, dryness; occurrence of all the other local AEs referred by the subject; occurrence of all the local Adverse Drug Reactions (ADRs) revealed by the Investigator | Up to 7 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base) plasma concentrations | At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1 | |
| Area under the plasma concentration versus time curve [AUC(0-t)] of econazole (free base), benzydamine (free base) and benzydamine N-oxide (free base) |
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Inclusion Criteria:
Informed consent: signed written informed consent before inclusion in the study;
Sex and age: females, aged 18-55 years old inclusive;
Body Mass Index (BMI): 18.5-30 kg/m2 inclusive;
Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest (sitting position);
Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study;
Sexual abstinence: agreement to sexual abstinence during the study;
Contraception and fertility: women of child-bearing potential, even if sexual abstinent during the study as required by the study inclusion criteria, must be using at least one reliable method of contraception, as follows:
PAP test: negative result at PAP test (i.e. normal PAP test result without atypical cells) at screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milko Radicioni, MD | Cross Research S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROSS Research S.A., Phase I Unit | Arzo | CH-6864 | Switzerland |
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| Drug |
|
| Placebo plus Benzydamine HCl 0.12% intravaginal cream | Drug |
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| Placebo intravaginal cream | Drug |
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| At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (days 1-2) and the last dose (days 15-16) and at pre-dose (0) on day 6±1, day 9±1 and day 12±1 |
| Treatment Emergent Adverse Events (TEAEs) | 15-16 days |
| Change from screening in vital signs | From screening (from day -21 to day -7) at days 1 and 15 at pre-dose (0), 12 and 24 hours post-dose |
| Change from screening in 12-leads ECG | From screening (from day -21 to day -7) at final visit (from day 17 to day 20) |
| Change from screening in laboratory parameters | From screening (from day -21 to day -7) and at final visit (from day 17 to day 20) |
| Change from screening in vaginal pH measurement | From screening (from day -21 to day -7), before the application on days 1, 2, 15, on days 6±1, 9±1, 12±1 at final visit (from day 17 to day 20) |
| Change from screening in gynaecological examination findings | From screening (from day -21 to day -7) at final visit (from day 17 to day 20) |
| Overall tolerability assessment scale | At final visit (from day 17 to day 20) |
| Questionnaire for the comfort of use | At final visit (from day 17 to day 20) |
| ID | Term |
|---|---|
| D004464 | Econazole |
| D001591 | Benzydamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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