| Gynecologic
Safety |
| Outline: |
Gynecologic
Safety-In-Use |
| Objective: |
To
determine irritation potential - a test article on the external
genitalia of women under actual use conditions.
|
| Subjects: |
30
healthy volunteers
|
| Timing: |
2-week
test
Start within 2 weeks of the time the test material is received
|
| Quantity: |
Clinical
assessment by a Board Certified Gynecologist |
|
Methodology: |
35
individual containers with enough product to last for at least 2 weeks
actual use conditions |
| Claims: |
Gynecologist
Tested
Safe for intended use
|
|
Procedures: |
On
study day 1, the Medical Investigator (a Board-Certified Gynecologist)
examines the external genitalia of approximately 30 subjects to determine
their eligibility for the study. Enrolled subjects are then given
the product to use at home for 2 weeks, use instructions and a daily
diary to record time of usage as well as any other significant comments.
After one week subjects call the testing facility. After 2 weeks,
they return for a follow-up exam by the Gynecologist.
|