| Eligibility |
Inclusion Criteria:
To be considered eligible for enrollment into this study subjects must meet the following
criteria (i.e., responses = "Yes"):
1. Have you read, understood, and signed the Informed Consent?
2. Have you read, understood and signed the Confidentiality Agreement?
3. Are you female, between 18 and 55 years of age (inclusive)?
4. For at least the last 4 months, have you had a consistent monthly menstrual cycle
lasting 21-35 days with menstrual bleeding lasting at least 3 days' duration?
5. Are you willing to wear the cup at least 12 hours (may remove to empty) a day and a
minimum of 3 days during your menstrual cycle?
6. Do you agree to use at least one form of birth control (i.e., intrauterine device,
oral contraceptives, contractive implants or injections, diaphragm with spermicide,
cervical cap, tubal ligation, partner had vasectomy or use of condom) if you are of
child-bearing potential for the duration of the study? Note: Abstinence will be
considered birth control in women not sexually active
7. Do you primarily use tampons (no slim/ultra slim) or menstrual cup for your feminine
protection needs during your periods (may use pads and/or pantiliners as
back-up/overnight use)?
8. Is your typical menstrual flow moderate/medium, heavy or extra heavy?
9. Do you wear tampons or menstrual cups during menstruation with no abnormal discomfort?
10. Was your last Papanicolaou (PAP) smear normal in the past 3 years (or have a normal
PAP with a negative Human Papilloma Virus (HPV) in the past 5 years)? NOTE: Women age
18-20 do NOT need a PAP regardless of sexual activity or not (per ACOG guidelines),
(self-reported)
11. In the past 48 hours, have you refrained from - and do you agree to continue to
refrain from - vaginal intercourse within the 48 hours before each visit?
12. Have you refrained from showering within 12 hours and/or bathing within 24 hours of
this visit - and do you agree to continue to refrain from - showering within 12 hours
and/or bathing within 24 hours before each visit?
13. In the past 48 hours, have you refrained from - and do you agree to continue to
refrain from - using douching substances, feminine hygiene products, powders,
perfumes, wipes, lotions, creams, or emollients to your genital area for the duration
of the study?
14. Do you agree to refrain from genital hair removal (e.g. waxing, shaving, etc.) while
on the study?
15. Do you agree to refrain from using antibacterial body soap while on the study? NOTE:
Hand washing is ok (e.g., Safeguard®, Dial®)
16. Have you refrained from - and do you agree to continue to refrain from - using
antihistamines (e.g., Benadryl®) or non-steroidal anti-inflammatory medication (e.g.
Advil®, Aspirin) for at least 3 days prior to each visit?
17. Do you agree to refrain from participation in other concurrent clinical research
studies?
18. Do you agree to only use the menstrual cups, pads and pantiliners supplied at each
study visit for menstrual protection while participating in this study?
19. Do you agree to refrain from using tampons during this study?
20. Do you agree to complete all study questionnaires and diaries?
21. Are you willing to keep fingernails at a suitable length and condition to help prevent
injury during product insertion and removal?
22. Are you willing and able to comply with the study requirements?
23. SITE: Is the subject in generally good health? (without clinically significant disease
as determined by Investigator/Designee based on medical history and vaginal exam)
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following (i.e., responses
= "Yes"):
1. Have you had a menstrual abnormality with any of your last menstrual cycles in the
last 4 months (such as oligomenorrhea or amenorrhea, or bleed more than 7 days a
month)?
2. Have you had a vaginal delivery in the last 6 months?
3. Are you pregnant (SITE: per urine pregnancy test at screening), lactating or planning
to become pregnant during the duration of the study?
4. Have you had vaginal surgery, perineal surgery, uterine surgery, miscarriage or
abortion (spontaneous or induced) in the last 6 months?
5. Do you have difficulty emptying your bladder?
6. Do you have a history of Toxic Shock Syndrome (TSS)?
7. Have you taken steroids within the past seven days? Exception: Topical steroids
outside the perineal/vaginal area are okay, at the discretion of the Investigator.
8. Do you currently or have you taken anticoagulants within the last 30 days (e.g.,
Coumadin® [warfarin], Eliquis® and/or Xarelto®) or have a bleeding disorder?
(self-reported)?
9. Do you have a vulvar piercing?
10. Do you have a history of genital herpes?
11. Within the last 6 months have you had endometrial disease/uterine fibroids with heavy
menstrual flow?
12. Have you been diagnosed or had a chemical dependence within the last 2 years (e.g.,
opiates, marijuana, etc.)? (self-reported).
13. Do you currently have a urinary tract infection (UTI) or a history of frequent UTIs (>
2 times within previous 12 months)? (self-reported).
14. Do you have urinary incontinence which causes you to regularly use and saturate
diapers or absorbent panties or pads (more than 3 times a week over the last 4
months), or have you been treated for a pelvic floor disorder (e.g., perineal floor
re-education with vaginal probe) within last 6 months?
15. Are you currently using a vaginal probiotic therapy? (self-reported).
16. Have you participated in a clinical study with exposure to any investigational product
within the last 30 days?
17. Have you taken any antibiotics or antifungals within last 4 weeks? Note: Topical use
of antibiotics or antifungals outside the perineal/genitourinary area is allowed at
the discretion of the Investigator.
18. Have you started a new hormonal birth control in the last 4 months, or plan changing
hormonal birth control during the study period?
19. Do you have a history of Light Emitting Diode(LED) or laser vaginal therapy within the
last 6 months? (self-reported).
20. Are you or a household member employed by any subsidiaries in the feminine care or
incontinence business, including Procter & Gamble, Johnson & Johnson, Kimberly Clark,
Energizer Holdings, SCA, Unicharm, Diva Cup International and First Quality?
21. SITE: Has the subject been diagnosed with a medical condition which might compromise
the immune system including cancer, anemia, blood disorders, or malnutrition within
the last 2 years? Exception - Successfully removed non-melanoma skin cancers outside
the test area are okay at the discretion of the Investigator (self-reported).
22. SITE: Does the subject have uncontrolled and/or unstable diabetes in the opinion of
the Investigator? Note: Must be on stable dose of medication for at least 6 months.
23. SITE: Does the subject have a history of immunosuppressive drug therapy, chemotherapy,
or radiation therapy?
24. SITE: Does the subject have history of or current diagnosis of AIDS/HIV, organ
transplant, liver disease, renal disease, deep vein thrombosis, pulmonary embolism,
haemophilia, autoimmune disease, thyroid disorder, major depression, Crohn's disease,
Irritable Bowel Disease or any other medical condition, which in the opinion of the
Investigator would preclude study participation? Note: For thyroid: acceptable if on a
stable dose of medication for at least 6 months.
25. SITE: Does the subject have a vaginal erythema grade of > 2 or a score of > 1.0 for
abrasions, ulcerations and/or lacerations as determined by the Investigator at the
screening visit?
26. SITE: Has the subject been diagnosed with an atrophic vagina defined as thin, friable
vaginal epithelium that bleeds on speculum examination (i.e. undiagnosed atrophy;
subject may report experiencing pain on intercourse) (self-reported)?
27. SITE: Has the subject been diagnosed with pelvic organ prolapse in any compartment
(anterior, apical or posterior)?
28. SITE: Does the subject have active vaginal infections (Chlamydia trachomatis and/or
Neisseria gonorrhoeae) identified through lab results from the microbiological sample
obtained at the screening visit?
29. SITE: Does the subject have active genital warts, lesions, and/or vaginal infections
(such as bacterial vaginosis (BV), Candida spp., Trichomonas vaginalis) at the
screening visit?
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