A phase III, single-blind trial to assess efficacy and tolerability of genital mucosa after use of product INC056
Completed
- Conditions
- ocal irritability and dryness of vaginaUrological and Genital DiseasesPain and other conditions associated with female genital organs and menstrual cycle
- Registration Number
- ISRCTN64791295
- Lead Sponsor
- Incrementha PD&I (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 65
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate vaginal acidification after product use (lowering of vaginal pH) at all visits (baseline and days 14, 30, 37 and 52).
- Secondary Outcome Measures
Name Time Method The following will be assessed at all visits (baseline and days 14, 30, 37 and 52):<br>1. Assessment of all adverse events reported <br>2. Assessment of vaginal dryness and/or sexual discomfort <br>3. Occurrence of recurrent vaginal infections in volunteers<br>4. Investigator's Global Assessment <br>5. Volunteer's Global Assessment<br>6. Assessment measured by acceptability questionnaire <br>7. Interruption of use due allergic reactions or irritability