In-use Study of Four Different Tampons

Inclusion Criteria: To be considered eligible for enrollment into this study subjects must meet the following criteria:

• signed the Informed Consent;
• female, between 18 and 55 years of age;
• agree to practice abstinence or use an effective form of birth control (e.g. intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or constant use of condom) for at least the past 4 months and willing to continue throughout the study or have had a tubal ligation or your partner has had a vasectomy at least 4 months before being enrolled in the study;
• be in generally good health without clinically significant disease as determined by investigator or designee based on medical history and vaginal exam;
• for at least the last 4 months, have a consistent menstrual cycle lasting 21-35 days with menstrual bleeding lasting at least 3 days' duration;
• primarily use tampons for their feminine protection needs during their periods (may use provided pads and/or pantiliners as back-up to tampon);
• typically use Regular (6-9 grams) absorbency tampons for the majority of their period,
• wears tampons during menstruation with no history of abnormal discomfort;
• last pap smear was normal in the past 3 years or a normal pap with a negative HPV in the past 5 years (age 18-21 does NOT need a PAP if they have never been sexually active), per standard of care (per ACOG guidelines), (self-reported);
• agree to refrain from vaginal intercourse within 48 hours of each vaginal exam scheduled visit;
• agree to refrain from showering within twelve (12) hours or bathing within twenty-four (24) hours (1 day) of each visit (except Visit 2);
• agree to refrain from using douching substances, feminine hygiene products, and to not apply powders, perfumes, wipes, lotions, creams, or emollients to their genital area 48 hours prior to the screening visit and through the completion of the study, if accepted to participate in the study;
• agree to refrain from taking anti-inflammatory, antihistamine and/or, steroid systemic and/or topical, (including new hormonal contraceptives) medications until they have completed the study (e.g. Advil, Motrin, Benadryl, etc.);
• agree to only use the tampons, pads and pantiliners supplied at each study visit for her menstrual protection while participating in this study;
• be willing and able to comply with the study requirements;
• agree to complete all study questionnaires;
• agree to refrain from participation in other concurrent clinical research studies;
• agree to refrain from genital hair removal (e.g. waxing/shaving, etc.) while on the study;
• agree to refrain from using antibacterial body soap while on the study (e.g. Safeguard)

Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following criteria:

• have a menstrual abnormality with in the last 4 months (such as oligomenorrhea or amenorrhea);
• has had a vaginal delivery in the last 6 months;
• had vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion in the last 6 months;
• are pregnant (per urine pregnancy test at screening), or intend to become pregnant in the next 5 months;
• have a history of Toxic Shock Syndrome (TSS);
• have a history of heart valve replacement;
• have had an abnormal Pap in either of your last 2 Pap Smears;
• have taken steroids (systemic and/or topical), corticosteroids, antihistamines, and/or anti-inflammatories within the past seven days (excludes hormonal contraception);
• have a history of immunosuppressive drug therapy, chemotherapy, or radiation therapy;
• have uncontrolled and/or unstable diabetes (exception...stable dose of Diabetic medication for at least 6 months prior to enrollment) in the opinion of the Investigator;
• have a vulvar piercing;
• have a history of genital herpes;
• within the last 6 months have had endometrial disease/uterine fibroids with symptoms o