Clinical Study
Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine
Table 3
Number of subjects reporting and number of reported TEAEs by treatment, system organ class (SOC), and preferred term (PT) (safety set)
.
| MedDRA description SOC and PT term | T
| R1
| R2
| P
| AEs
| Subjects (%) | AEs
| Subjects (%) | AEs
| Subjects (%) | AEs
| Subjects (%) |
| Total number of AEs and of subjects with at least one AE | 7 | 7 (53.8) | 9 | 5 (41.7) | 2 | 2 (16.7) | 1 | 1 (8.3) | General disorders and administration site conditions | 3 | 3 (23.1) | 5 | 4 (33.3) | 0 | 0 | 0 | 0 | Application site reaction | 0 | 0 | 4 | 4 (33.3) | 0 | 0 | 0 | 0 | Application site pruritus | 2 | 2 (15.4) | 1 | 1 (8.3) | 0 | 0 | 0 | 0 | Application site pain | 1 | 1 (7.7) | 0 | 0 | 0 | 0 | 0 | 0 | Investigations | 0 | 0 | 2 | 2 (16.7) | 2 | 2 (16.7) | 1 | 1 (8.3) | Gardnerella test positive | 0 | 0 | 1 | 1 (8.3) | 1 | 1 (8.3) | 0 | 0 | Candida test positive | 0 | 0 | 0 | 0 | 1 | 1 (8.3) | 0 | 0 | Chlamydia test positive | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (8.3) | Streptococcus test positive | 0 | 0 | 1 | 1 (8.3) | 0 | 0 | 0 | 0 | Nervous system disorders | 4 | 4 (30.8) | 1 | 1 (8.3) | 0 | 0 | 0 | 0 | Headache | 3 | 3 (23.1) | 1 | 1 (8.3) | 0 | 0 | 0 | 0 | Dizziness | 1 | 1 (7.7) | 0 | 0 | 0 | 0 | 0 | 0 | Gastrointestinal disorders | 0 | 0 | 1 | 1 (8.3) | 0 | 0 | 0 | 0 | Nausea | 0 | 0 | 1 | 1 (8.3) | 0 | 0 | 0 | 0 |
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TEAE: treatment emergent adverse event; AE: adverse event; T: test fixed-dose combination of econazole nitrate 150 mg/benzydamine hydrochloride 6 mg vaginal ovules; R1: reference 1 econazole nitrate 150 mg only ovules; R2: reference 2 benzydamine hydrochloride 6 mg only ovules; P: placebo vaginal ovules. MedDRA version 19.0.
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