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MenstruationNCT05411796

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

A study testing Tampax menstrual cup and Other menstrual cup in people with Menstruation, run by Procter and Gamble at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluated the safety and tolerability of two different menstrual cups on vaginal health Read more about this study

Who is it for?
Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Menstruation
What is being tested?
Tampax menstrual cup and Other menstrual cup
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
7 Aug 2018to 14 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • To be considered eligible for enrollment into this study subjects must meet the following criteria (i.e., responses = "Yes"):
  • 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?
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  • 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?
  • Do you wear tampons or menstrual cups during menstruation with no abnormal discomfort?
  • 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)
  • 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?
  • 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?
  • 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?
  • Do you agree to refrain from genital hair removal (e.g. waxing, shaving, etc.) while on the study?
  • Do you agree to refrain from using antibacterial body soap while on the study? NOTE: Hand washing is ok (e.g., Safeguard®, Dial®)
  • 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?
  • Do you agree to refrain from participation in other concurrent clinical research studies?
  • 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?
  • Do you agree to refrain from using tampons during this study?
  • Do you agree to complete all study questionnaires and diaries?
  • Are you willing to keep fingernails at a suitable length and condition to help prevent injury during product insertion and removal?
  • Are you willing and able to comply with the study requirements?
  • SITE: Is the subject in generally good health? (without clinically significant disease as determined by Investigator/Designee based on medical history and vaginal exam)

Who cannot join

  • Subjects will be excluded from the study if they meet any of the following (i.e., responses = "Yes"):
  • 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?
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  • 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)?
  • Do you have a vulvar piercing?
  • Do you have a history of genital herpes?
  • Within the last 6 months have you had endometrial disease/uterine fibroids with heavy menstrual flow?
  • Have you been diagnosed or had a chemical dependence within the last 2 years (e.g., opiates, marijuana, etc.)? (self-reported).
  • Do you currently have a urinary tract infection (UTI) or a history of frequent UTIs (> 2 times within previous 12 months)? (self-reported).
  • 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?
  • Are you currently using a vaginal probiotic therapy? (self-reported).
  • Have you participated in a clinical study with exposure to any investigational product within the last 30 days?
  • 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.
  • Have you started a new hormonal birth control in the last 4 months, or plan changing hormonal birth control during the study period?
  • Do you have a history of Light Emitting Diode(LED) or laser vaginal therapy within the last 6 months? (self-reported).
  • 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?
  • 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).
  • 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.
  • SITE: Does the subject have a history of immunosuppressive drug therapy, chemotherapy, or radiation therapy?
  • 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.
  • 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?
  • 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)?
  • SITE: Has the subject been diagnosed with pelvic organ prolapse in any compartment (anterior, apical or posterior)?
  • 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?
  • 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?

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Synexus-US

    Cincinnati, Ohio, 45236

Other trials in United States

About this study

Official title: In-Use Randomized, Cross-over, Double-blind Study of Two Different Menstrual Cups

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

Conditions
Menstruation
Being tested
Tampax menstrual cup, Other menstrual cup

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tampax menstrual cupDevice

    regular flow size

  • Other menstrual cupDevice

    size 1

Study groups in NCT05411796
Study groupRoleWhat they receive
Tampax menstrual cup (regular flow), then Other menstrual cup (size 1)ExperimentalNot described
Receives: Device: Tampax menstrual cup; Device: Other menstrual cup
Other menstrual cup (size 1), then Tampax menstrual cup (regular flow)ExperimentalNot described
Receives: Device: Tampax menstrual cup; Device: Other menstrual cup

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaginal erythema

    visually graded on a scale of 0 (no apparent erythema) to 4 (severe erythema)

    Measured: within 72 hours of last menstrual cup use

Secondary outcomes (1)

  1. Vaginal abrasion

    visually graded on a scale of 0 (intact) to 2 (deep disruption)

    Measured: within 72 hours of last menstrual cup use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start7 Aug 2018
  3. Primary completion14 Nov 2018
  4. Study completion14 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05411796
Sponsor's protocol ID
CSD 2018094
Status last verified
Jun 2022
First submitted
20 May 2022
Last updated
9 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tampax menstrual cup and Other menstrual cup in people with Menstruation, run by Procter and Gamble at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaginal erythema (time frame: within 72 hours of last menstrual cup use). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05411796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

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