Clinical trial: In-use Study of Four Different Tampons (NCT03478371)

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

          1. signed the Informed Consent;

          2. female, between 18 and 55 years of age;

          3. 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;

          4. be in generally good health without clinically significant disease as determined by
             investigator or designee based on medical history and vaginal exam;

          5. 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;

          6. primarily use tampons for their feminine protection needs during their periods (may
             use provided pads and/or pantiliners as back-up to tampon);

          7. typically use Regular (6-9 grams) absorbency tampons for the majority of their period,

          8. wears tampons during menstruation with no history of abnormal discomfort;

          9. 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);

         10. agree to refrain from vaginal intercourse within 48 hours of each vaginal exam
             scheduled visit;

         11. agree to refrain from showering within twelve (12) hours or bathing within twenty-four
             (24) hours (1 day) of each visit (except Visit 2);

         12. 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;

         13. 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.);

         14. agree to only use the tampons, pads and pantiliners supplied at each study visit for
             her menstrual protection while participating in this study;

         15. be willing and able to comply with the study requirements;

         16. agree to complete all study questionnaires;

         17. agree to refrain from participation in other concurrent clinical research studies;

         18. agree to refrain from genital hair removal (e.g. waxing/shaving, etc.) while on the
             study;

         19. 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:

          1. have a menstrual abnormality with in the last 4 months (such as oligomenorrhea or
             amenorrhea);

          2. has had a vaginal delivery in the last 6 months;

          3. had vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion in the
             last 6 months;

          4. are pregnant (per urine pregnancy test at screening), or intend to become pregnant in
             the next 5 months;

          5. have a history of Toxic Shock Syndrome (TSS);

          6. have a history of heart valve replacement;

          7. have had an abnormal Pap in either of your last 2 Pap Smears;

          8. have taken steroids (systemic and/or topical), corticosteroids, antihistamines, and/or
             anti-inflammatories within the past seven days (excludes hormonal contraception);

          9. have a history of immunosuppressive drug therapy, chemotherapy, or radiation therapy;

         10. 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;

         11. have a vulvar piercing;

         12. have a history of genital herpes;

         13. 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;

         14. 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);

         15. have clinically diagnosed genital warts, lesions, and/or vaginal infections (such as
             bacterial vaginosis (BV), Candida spp., Trichomonas vaginalis) at the screening visit;

         16. 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;

         17. 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);

         18. 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);

         19. having a vaginal probiotic therapy (self-reported)

         20. have participated in a clinical study with exposure to any investigational drug
             product within 30 days prior to this study;

         21. 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;

         22. 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);

         23. have started a new hormonal birth control in the previous 4 months or plan changing
             hormonal birth control throughout the study period;

         24. currently experiencing bladder, uterine or rectal prolapse (investigator to verify at
             screening visit).

         25. history of led or laser vaginal therapy within last 6 months (self-reported)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction