ISRCTN64791295
Completed
Not Applicable
A phase III, single-blind, single-centre trial to assess efficacy and tolerability of genital mucosa after use of product INC056 in post-menopausal women
Incrementha PD&I (Brazil)0 sites65 target enrollmentAugust 1, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Incrementha PD&I (Brazil)
- Enrollment
- 65
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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