Status:
COMPLETED
Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Vaginal Microflora
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. A tota...
Detailed Description
Subjects will be using investigational or control tampons during their menstrual period but these tampons are not intended to prevent, treat or diagnose an infection or other disease condition. This s...
Eligibility Criteria
Inclusion
- normal healthy women
- 18-45 years of age
- regular 21- to 35-day menstrual cycles with at least 5 days of bleeding, or at least 3 days of bleeding if they are using hormonal contraception
- used tampons as their principal mode of menstrual sanitary protection for at least the previous 6 months
- willing to not change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
Exclusion
- signs or symptoms of clinically significant vulvovaginal infection or vaginosis
- history of recurrent urinary tract or vulvovaginal infection
- abnormal vaginal discharge of any etiology
- use of a systemic, vaginal, or perineal antibiotic, antifungal, anti-infective, or immunosuppressant medication or any experimental drug or medical device within the 30 days preceding the Screening/Baseline Visit
- history of treatment for Toxic Shock Syndrome (TSS) or a suspicion of having had TSS
- other clinical issues or history (per protocol) that would make participation in the trial inappropriate
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT00913523
Start Date
January 1 2009
End Date
August 1 2009
Last Update
August 23 2011
Active Locations (2)
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1
Hill Top Research
Scottsdale, Arizona, United States, 85251
2
Hill Top Research
St. Petersburg, Florida, United States, 33710