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| ID | Type | Description | Link |
|---|---|---|---|
| CRO-PK-15-302 | 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 the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and placebo. Pharmacokinetics of the study products after single and multiple applications o.d. for 3 days, overall local and general tolerability, safety and comfort of use will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Econazole nitrate 150 mg plus Benzydamine HCl 6 mg | Experimental | One vaginal pessary (2.7 g) of Econazole nitrate 150 mg plus Benzydamine HCl 6 mg, once daily, for 3 consecutive days |
|
| Placebo plus Econazole nitrate 150 mg | Active Comparator | One vaginal pessary (2,7 g) of Placebo plus Econazole nitrate 150 mg, once daily, for 3 consecutive days |
|
| Placebo plus Benzydamine HCl 6 mg | Active Comparator | One vaginal pessary (2,7 g) of Placebo plus Benzydamine HCl 6 mg, once daily, for 3 consecutive days |
|
| Placebo | Placebo Comparator | One vaginal pessary (2.7 g) of Placebo, once daily, for 3 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary | Drug | Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Adverse Drug Reactions (ADRs) | Occurence of local ADRs reported by the subjects as 1-3 scores for pruritus, burning sensation, pain, stinging and dryness; occurrence of all the other local Adverse Events (AEs) referred by the subjects; occurrence of all the local ADRs revealed by the Investigator/ Gynaecologist | 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 (day 1) and the last dose (day 3) | |
| 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: healthy women, 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 sexually 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 PAP test result (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. Phase I Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROSS Research S.A., Phase I Unit | Arzo | CH-6864 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32410819 | Derived | Di Stefano AFD, Radicioni MM, Vaccani A, Caccia G, Focanti F, Salvatori E, Pelacchi F, Picollo R, Rosignoli MT, Olivieri S, Bovi G, Comandini A. Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine. Infect Dis Obstet Gynecol. 2020 May 2;2020:7201840. doi: 10.1155/2020/7201840. eCollection 2020. |
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| Placebo plus Econazole nitrate 150 mg vaginal pessary | Drug |
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| Placebo plus Benzydamine HCl 6 mg vaginal pessary | Drug |
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| Placebo vaginal pessary | Drug |
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| At pre-dose (0), 1, 2, 3, 4, 6, 8, 12, 24 hours after the first (day 1) and the last dose (day 3) |
| Overall local tolerability assessment scale | At final visit (from day 5 to day 8) |
| Occurrence of all AEs and ADRs | 5-8 days |
| Change from screening in laboratory parameters | From screening (from day -21 to day -7) at final visit (from day 5 to day 8) |
| Questionnaire for the comfort of use | At final visit (from day 5 to day 8) |
| ID | Term |
|---|---|
| D004464 | Econazole |
| D001591 | Benzydamine |
| D013488 | Suppositories |
| 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 |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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