In-use Cross-over Study of Two Different Menstrual Cups (NCT05411796) | Clinical Trial Compass
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
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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?
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaginal erythema
Timeframe: within 72 hours of last menstrual cup use
. 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)?