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

NCT05411796 | Completed

• 1 other identifier: CSD 2018094
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menstruation

Outcome Measures

Primary Outcomes (1)

• Vaginal erythema

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

  within 72 hours of last menstrual cup use

Secondary Outcomes (1)

• Vaginal abrasion

  within 72 hours of last menstrual cup use

Study Arms (2)

Tampax menstrual cup (regular flow), then Other menstrual cup (size 1)

EXPERIMENTAL

Device: Tampax menstrual cup; Device: Other menstrual cup

Other menstrual cup (size 1), then Tampax menstrual cup (regular flow)

EXPERIMENTAL

Device: Tampax menstrual cup; Device: Other menstrual cup

Interventions

Tampax menstrual cup DEVICE

regular flow size

Other menstrual cup (size 1), then Tampax menstrual cup (regular flow); Tampax menstrual cup (regular flow), then Other menstrual cup (size 1)

Other menstrual cup DEVICE

size 1

Other menstrual cup (size 1), then Tampax menstrual cup (regular flow); Tampax menstrual cup (regular flow), then Other menstrual cup (size 1)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Females with regular menstrual cycles
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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?
• 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?

You may not qualify if:

• 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?
• 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?

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Synexus-US

Cincinnati, Ohio, 45236, United States

Location

Study Officials

• Michael Noss, M.D.

  Synexus, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: menstrual cups distributed in unmarked packaging; participants and investigator blinded
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 9, 2022
• Study Start: August 7, 2018
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)