Clinical Evaluation of Effects of an Investigational Tampon on Vaginal Microflora

Completed · Not applicable · Has a placebo group

Conditions studied: Vaginal Microflora

In brief

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 total 450 women will participate in this study at two study sites. Subjects will be randomly assigned to one of three tampon groups. The first group will test an experimental test tampon containing glycerol monolaurate (GML) on the cover. The second group will test an identical tampon, but without GML. The third group will not be issued study tampons but will be instructed to use their normal tampon brand. This study is intended to determine whether the effects of GML observed in the laboratory can be demonstrated in healthy menstruating women.

Key facts

Study ID

NCT00913523

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

482

Starts

2009-01-01

Expected to finish

2009-08-01

Last updated by the study team

2011-08-23

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Hill Top Research — Scottsdale, Arizona, United States
• Hill Top Research — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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