Local irritability and dryness of vagina Urological and Genital Diseases Pain and other conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Pre-trial visit:
Prior to interventions, written informed consent will be gained. Screening assessment, vaginal pH testing, gynaecological exam and interview will be performed. The dose is one disposa
Sponsors
Incrementha PD&I (Brazil)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy female volunteers aged between 40 and 65 years 2. Post-menopausal women 3. Vaginal pH of 5.0 or higher 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Skin disease at site of administration 3. Diabetes mellitus 4. Immunological insufficiency 5. Use of systemic corticoid, antibiotics or steroids 6. Use of immunosuppressive drugs 7. Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis 8. Antifungal therapy within the last month at screening 9. History of infection at the site of drug administration 10. History of allergies to components of product 11. Other diseases or medications that could interfere with the research result or endanger the volunteer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate vaginal acidification after product use (lowering of vaginal pH) at all visits (baseline and days 14, 30, 37 and 52). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at all visits (baseline and days 14, 30, 37 and 52): 1. Assessment of all adverse events reported 2. Assessment of vaginal dryness and/or sexual discomfort 3. Occurrence of recurrent vaginal infections in volunteers 4. Investigator's Global Assessment 5. Volunteer's Global Assessment 6. Assessment measured by acceptability questionnaire 7. Interruption of use due allergic reactions or irritability | — |
Countries
Brazil
Outcome results
None listed