A double-blind, parallel, randomized, multicenter study to evaluate the safety and efficacy of NR034 (Ginuril®) versus lactic acid administered as co-adjuvant by vaginal route in women affected by a vaginal yeast infection and who are initiating treatment with clotrimazole vaginal tablets
Not Applicable
Completed
- Conditions
- Vaginal infectionUrological and Genital Diseases
- Registration Number
- ISRCTN12908359
- Lead Sponsor
- ovintethical Pharma (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 42
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
1. Pregnant women or breastfeeding
2. Unwilling to sign the informed consent form
3. Allergy to one of the product ingredients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br> 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<br>
- Secondary Outcome Measures
Name Time Method <br> Observed by self-report (patient diary) and by the physician during gynecological examinations:<br> 1. Mycological count on days 1, 3 and 7 of treatment<br> 2. Clinical symptoms:<br> 2.1. Itching evaluated using the Scott-Huskisson scale on days 1, 2, 3, 4, 5, 6, 7<br> 2.2. Leucorrhoea evaluated on days 1, 2, 3, 4, 5, 6, 7<br> 2.3. Dysuria evaluated on days 1, 2, 3, 4, 5, 6, 7<br> 2.4. Dyspareunia evaluated on days 1, 2, 3, 4, 5, 6, 7<br> 3. Vaginal pH measured on days 1, 3, 7<br>