Vaginal infection Urological and Genital Diseases
Conditions
Interventions
The participants are assigned randomly to a study treatment based on a computer randomized 1:1 scheme which generates the code of the treatment that is allocated to the specific patient. Participants
Sponsors
Novintethical Pharma (Switzerland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females between 18 and 50 years of age 2. Caucasian race 3. Suffering from vaginal yeast infection 4. Initiating therapy with clotrimazole vaginal tablets for 3 days 5. Signed informed consent form
Exclusion criteria
Exclusion criteria: 1. Pregnant women or breastfeeding 2. Unwilling to sign the informed consent form 3. Allergy to one of the product ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety: occurrence and classification of adverse events (AE)/serious adverse events (SAE)/suspected unexpected serious adverse reactions (SUSAR), recorded using patient diaries on days 1, 3 and 7 2. Occurrence of undesirable systemic or local effects reported by the patient or observed by the physician during the whole study period, recorded on days 1, 3 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Observed by self-report (patient diary) and by the physician during gynecological examinations: 1. Mycological count on days 1, 3 and 7 of treatment 2. Clinical symptoms: 2.1. Itching evaluated using the Scott-Huskisson scale on days 1, 2, 3, 4, 5, 6, 7 2.2. Leucorrhoea evaluated on days 1, 2, 3, 4, 5, 6, 7 2.3. Dysuria evaluated on days 1, 2, 3, 4, 5, 6, 7 2.4. Dyspareunia evaluated on days 1, 2, 3, 4, 5, 6, 7 3. Vaginal pH measured on days 1, 3, 7 | — |
Countries
Romania
Outcome results
None listed