In-use Study of Four Different Tampons

Study Overview
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Brief Summary
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This study will evaluate the impact on vaginal health of four different tampons using gynecologic assessment and subjective assessment of comfort during in-use conditions

Official Title
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In-use Randomized, Cross-over, Controlled Double-blind Study of Four Different Tampons

Conditions
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Menstruation

Intervention / Treatment
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* Device: tampon D
* Device: tampon M
* Device: tampon T
* Device: tampon V


Participation Criteria
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Eligibility Criteria
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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 of heavy menstrual flow (super plus tampon absorbency use) and/or severe menstrual cramping; have you been diagnosed with a current medical condition which might compromise the immune system functions; including cancer, anemia, leukopenia, leukocyte function deficiency, malnutrition, or chemical dependence (e.g. opiates, marijuana etc.) (self-reported); have clinically diagnosed genital warts, lesions, and/or vaginal infections (such as bacterial vaginosis (BV), Candida spp., Trichomonas vaginalis) at the screening visit; have clinically diagnosed active or vaginal infections (Chlamydia trachomatis and/or Neisseria gonorrhoeae) identified through lab results from the microbiological sample obtained at the screening visit; has urinary incontinence which causes subject to regularly use and saturate diapers or absorbent panties or pads more than 3 times a week over the last 4 months, or currently under treatment for a pelvic floor disorder (i.e., perineal floor re-education with vaginal probe within last 6 months); have history of or current diagnosis of AIDS/HIV, organ transplant, neoplasia, liver disease, renal disease, deep vein thrombosis, pulmonary embolism, haemophilia, neutropenia, autoimmune disease, major depression or any other medical condition, which in the opinion of the Investigator would preclude study participation (exception...stable dose of Thyroid medication for at least 6 months prior to enrollment); having a vaginal probiotic therapy (self-reported) have participated in a clinical study with exposure to any investigational drug product within 30 days prior to this study; have a vaginal erythema grade of ≥2.0 and/or the presence of abrasions and/or ulcerations as determined by investigator, at the screening visit; have taken antibiotics or antifungals within last 4 weeks (Topical use of antibiotics or antifungals outside the perineal/genitourinary area is allowed at the discretion of the Investigator); have started a new hormonal birth control in the previous 4 months or plan changing hormonal birth control throughout the study period; currently experiencing bladder, uterine or rectal prolapse (investigator to verify at screening visit). history of led or laser vaginal therapy within last 6 months (self-reported)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Marketed Tampon D<br>Regular absorbency tampon | Device: tampon D<br>* regular absorbency tampon<br>|
| Sham Comparator: Marketed Tampon M<br>Regular absorbency tampon | Device: tampon M<br>* regular absorbency tampon<br>|
| Sham Comparator: Marketed Tampon T<br>Regular absorbency tampon | Device: tampon T<br>* regular absorbency tampon<br>|
| Sham Comparator: Marketed Tampon V<br>Regular absorbency tampon | Device: tampon V<br>* regular absorbency tampon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health | The physician examiner determined tampon tolerance based on the following: 1) Vaginal erythema (0-4 scale), 2) vaginal lacerations (presence or absence), 3) vaginal abrasions (presence or absence), 4) vaginal pH, 5) vaginal discharge | within 72 hours last tampon use | 
| Vaginal pH | Vaginal pH | within 72 hours last tampon use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Comfort Diary | Diary assessment of tampon wear comfort. This assessment uses a 5-point scale which was summarized using the mean as the summary statistic. This questionnaire measured overall comfort using a +2 to -2 scale that was converted to a 0 to 100 scale: 100 = excellent rating and 0 =poor rating | 4 months | 
| Subject Comfort Questionnaire | Post-menstruation assessment of tampon wear comfort. This assessment uses a 5-point scale which was summarized using the mean as the summary statistic. This questionnaire measured overall satisfaction using a +2 to -2 scale that was converted to a 0 to 100 scale: 100 = excellent rating and 0 = poor rating | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tampon