CompletedNot Applicable

In-use Cross-over Study of Two Different Menstrual Cups

United States65 participantsStarted 2018-08-07

Plain-language summary

This study evaluated the safety and tolerability of two different menstrual cups on vaginal health

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Have you read, understood, and signed the Informed Consent?
✓. Have you read, understood and signed the Confidentiality Agreement?
✓. Are you female, between 18 and 55 years of age (inclusive)?
✓. 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?
✓. 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?
✓. 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
✓. 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)?
✓. Is your typical menstrual flow moderate/medium, heavy or extra heavy?

✕. 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)?
✕. Have you had a vaginal delivery in the last 6 months?
✕. Are you pregnant (SITE: per urine pregnancy test at screening), lactating or planning to become pregnant during the duration of the study?
✕. Have you had vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion (spontaneous or induced) in the last 6 months?
✕. Do you have difficulty emptying your bladder?
✕. Do you have a history of Toxic Shock Syndrome (TSS)?
✕. 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.
✕. 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)?

Vaginal erythema

Timeframe: within 72 hours of last menstrual cup use

NCT IDNCT05411796

SponsorProcter and Gamble

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-14

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Have you read, understood, and signed the Informed Consent?
✓. Have you read, understood and signed the Confidentiality Agreement?
✓. Are you female, between 18 and 55 years of age (inclusive)?
✓. 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?
✓. 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?
✓. 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
✓. 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)?
✓. Is your typical menstrual flow moderate/medium, heavy or extra heavy?

✕. 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)?
✕. Have you had a vaginal delivery in the last 6 months?
✕. Are you pregnant (SITE: per urine pregnancy test at screening), lactating or planning to become pregnant during the duration of the study?
✕. Have you had vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion (spontaneous or induced) in the last 6 months?
✕. Do you have difficulty emptying your bladder?
✕. Do you have a history of Toxic Shock Syndrome (TSS)?
✕. 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.
✕. 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)?