Study Evaluating the Optimal Dosage for Equivalence Between Lcr Regenerans® Capsules and Tablets (Lactobacillus Rhamnosus Lcr35®) on the Vaginal Flora Colonisation (COMPRIGEL)
Candidiasis, Vulvovaginal
About this trial
This is an interventional other trial for Candidiasis, Vulvovaginal focused on measuring mycosis, Candidiasis, Lcr35®, Lcr Regenerans®
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.
Sites / Locations
- BIOSE
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Lcr Regenerans® vaginal capsule
Lcr Regenerans® vaginal tablet every 3 days
Lcr Regenerans® vaginal tablet every 4 days
Lcr Regenerans® vaginal tablet every 5 days
Name: Lcr Regenerans® containing at least 10e7 CFU per intravaginal capsule. 1 vaginal capsule per day
Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 3 days
Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 4 days
Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 5 days