Evaluation of GNR034 cream versus lactic acid cream to compare the effectiveness and safety in treating women diagnosed with a vaginal yeast infection

INTERVENTION: 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 are instructed to administer product A or B once per day for 7 consecutive days. The treatments (Product A or Product B) are administered by the vaginal route according to the approved leaflet. One group receives GNR034 (Ginuril® cream) and the other group lactic acid. Patients attend three visits: 1. Baseline visit (Visit 1) 2. Visit 2 after 3 days of treatment 3. End of study visit (Visit 3), 7 days after beginning treatment CONDITION: Vaginal infection ; Urological and Genital Diseases PRIMARY OUTCOME: ; 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 OUTCOME: ; 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; 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