Healthy premenopausal female volunteers.
Conditions
Interventions
Group 1: KadeFlora® Milchsäureovula (pessaries), 1 pessary/day, for 7 days
Sponsors
DR. KADE Pharmazeutische Fabrik GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: - Willingness to abstain from sexual intercourse, vaginal douching, and the use of other vaginal products in the last 24 hours before Day 1, during the clinical investigation, and 24 hours after the last IMD application. - Consent to treatment scheduling of the IMD as follows: Treatment with IMD must not take place during menstrual bleeding, but should begin at least 3-4 days after end of the last menstrual period, and should end at least 7 days before the next expected menstrual bleeding. - The physical examination including vaginal/vulval examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical investigation. - Female volunteers of childbearing potential1 agree to use an acceptable birth control method (failure rate of more than 1% per year, lower is also acceptable) including. - Written informed consent obtained.
Exclusion criteria
Exclusion criteria: - Clinically significant illness that may influence the outcome of the clinical investigation in the 4 weeks before the screening visit and during the clinical investigation. - Participants with symptomatic BV according to Amsel criteria - Participants with presence of Vulvovaginal candidiasis or Trichomonas vaginalis - Clinical suspicion of presence any other infectious cause of vulvovaginitis (e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, active herpes simplex, or human papillomavirus [presence of condylomata acuminata]) based on genital inspection. - Presence of any clinically apparent other vaginal or vulvar disease based on genital inspection. -Vaginal erythema, edema, or discharge rated with score > 1 in the clinical assessment. -Participants who are currently receiving any systemic or topical (within the genital region) antibacterial therapy (of any kind). -Treatment with any other systemic medications or treatments acting locally in the vaginal area which might have countered or influenced the clinical investigation aim within 2 weeks before the screening visit and during this clinical investigation (e.g., glucocorticosteroids, local estrogen, lactic acid, lactobacilli, or antimycotics). -Known or suspected hypersensitivity or known allergic reactions to components of the IMD. - Evidence of drug or alcohol abuse. - Pregnancy or nursing. - Participation in the treatment phase of another clinical investigation or clinical trial within the last 4 weeks prior to screening and during the conduct of this clinical investigation. - In the opinion of the investigator participant should not take part in the clinical investigation, e.g., due to probable non-compliance or inability to understand the clinical investigation and adequately given informed consent. - Close affiliation with the investigator (e.g., a close relative) or persons working at Eurofins bioskin GmbH or participant is an employee of the sponsor. - Participant is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Frequency count and percentage of participants assessed with erythema, edema and/or discharge (5-point scale) of grade 0 or 1 (tolerable) and grade 2-4 (intolerable) by the investigator on Day 8+2 days . | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mean change from baseline (screening) to Day 8+2 days in vaginal pH-value as measured by the participant under supervision at clinical investigation center. - Mean change from baseline (Day 1, before application) to Days 2, 3, and 5 in vaginal pH value as measured by the participant at home. - Frequency counts for itching, burning, and soreness (5-point scale) as assessed by the participants on Day 8+2 days. - Overall incidence of adverse device effect, adverse effect and device deficiencies. | — |
Countries
Germany
Contacts
Public ContactRuth Diebold
DR. KADE Pharmazeutische Fabrik GmbH
Outcome results
None listed