Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT02251093
Eligibility Criteria:
Inclusion Criteria:
* Patient suffering from recurrent VVC (RVVC) defined by the existence of at least 4 VVC episodes during the past year, including the one concerned by the screening visit In addition to the current episode, at least one episode occurring during the two previous years must also have been documented by mycological examination
* Patient suffering from acute vulvovaginitis characterised by the presence of the following clinical criteria at V1 (pruritus symptoms, vulvovaginal signs such as erythema, vaginal discharge)
* Patient with a positive mycological examination at V1
* Patient cured in clinical terms 8 days after treatment with MONAZOL 300 mg vaginal suppositories (one suppository at night before sleep, single administration) and followed by the application of MONAZOL 2 pourcent cream (8-day treatment)
* Woman of child-bearing age with a negative urine pregnancy test and using a means of contraception deemed effective by the investigator (excluding spermicides) throughout the trial
* Patient/Legal representative able to speak and read the local language, having been informed of the trial and having voluntarily signed an Informed Consent Form
* Patient/Legal representative registered with a social insurance scheme
Exclusion Criteria:
* Presence of a presumed or proven, gynaecologically-related bacterial or viral infection, whether treated or not during the month preceding the inclusion, or present at the time of inclusion.
* Presence of an existing gynaecological infection that could interfere with the assessment of the trial treatment (severe cervical dysplasia or carcinoma in situ, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
* Patients with a negative mycological examination at V1
* Lack of adequately documented previous episodes to assert the recurrent nature of the VVC (4 episodes in one year, two of which documented by mycological examination over the past two years \[thus, in addition to the current episode, at least one episode occurring during the two previous years must also have been documented by mycological examination\])
* Antifungals taken by general route (in particular Fluconazole) during the month preceding the screening visit, in view of preventing recurrences (the treatment of an acute VVC episode is not an exclusion criterion).
* Use of probiotics in the month preceding the screening visit.
* Use of prebiotics (acidifiers) during the two weeks preceding the screening visit.
* Allergy to one of the active ingredients or one of the excipients in the products.
* Patient unable to comply with the constraints of the Protocol.
* Breastfeeding patient.
* Patient with menstrual bleeding lasting more than 8 days a month.
* Post-menopausal women with last menstrual period at least 12 months prior to screening
* Patient having taken part in a clinical trial in the 3 months preceding inclusion in the present Protocol.
* Patient with a severe acute or chronic disease deemed by the Investigator to be incompatible with participation in the trial, or a serious infection that is life-threatening in the short term.
* Immuno-suppressed patient.
* Patient presenting with a previous illness which, according to the Investigator, is likely to interfere with the results of the trial or expose the patient to an additional risk.
* Patient linguistically (unable to speak or write the local language) or mentally unable to understand and sign the Informed Consent Form.
* Patient deprived of her liberty by order of the Courts or civil authorities or subject to a guardianship order.
* Patient likely not to comply with treatment.
* Patient unable to be contacted in the case of an emergency.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT02251093
Study Brief:
Protocol Section:
NCT02251093