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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02730494
Eligibility Criteria:
Inclusion Criteria:
Relating to the condition:
* Clinically healthy women
Relating to the population:
* Adult women
* Women of child-bearing age: with a negative urine pregnancy test and using a method of contraception deemed effective by the investigator(excluding spermicides) throughout the trial
* Women who can be treated with the study product immediately after the inclusion visit for a duration of 21 consecutive days without interruption by her next menstrual period.
* Women who can speak and read French and having been informed about the study and having voluntarily signed an Informed Consent Form
* Women registered with a social insurance scheme
Exclusion Criteria:
* Relating to the condition or the gynaecological field:
* Presence of a presumed or proven gynaecological bacterial or viral infection, whether treated or not during the month preceding inclusion.
* Presence of an existing gynaecological condition 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.)
Relating to the treatments:
* Systemic antifungals or antibiotics during the month preceding the inclusion visit.
* Use of probiotics (see list in 16.2) during the month preceding the inclusion visit.
* Use of prebiotics (acidifying agents) - (see list in 16.2) during the 15 days preceding the inclusion visit.
* Allergy to one of the active ingredients or one of the excipients in the products.
Relating to the population:
* Women unable to comply with the constraints of the protocol.
* Breastfeeding women.
* Post-menopausal women.
* Women whose menstrual bleeding lasts longer than 8 days per month.
* Women having participated in a clinical study in the 3 months preceding inclusion in this protocol.
* Women with a severe acute or chronic condition deemed by the investigator as being incompatible with participation in the trial or a serious infection which could be life-threatening in the short term.
* Immunosuppressed women.
* Women with a previous condition which, according to the investigator, is likely to interfere with the study results or expose the female volunteer to additional risk.
* Women with linguistic (not speaking or writing French) or psychological inability to understand and sign the informed consent form.
* Women deprived of her liberty through an administrative or judicial decision or subject to a guardianship order.
* Women likely not to comply with the treatment.
* Women who cannot be contacted in the case of emergency.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02730494
Study Brief:
Protocol Section:
NCT02730494