In-use Study of Four Different Tampons

NCT03478371 | Completed Results FDA Device

• 1 other identifier: CSD 2017-164
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the impact on vaginal health of four different tampons using gynecologic assessment and subjective assessment of comfort during in-use conditions

Conditions

Menstruation

Keywords

tampon

Outcome Measures

Primary Outcomes (2)

• Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health

  The physician examiner determined tampon tolerance based on the following: 1) Vaginal erythema (0-4 scale), 2) vaginal lacerations (presence or absence), 3) vaginal abrasions (presence or absence), 4) vaginal pH, 5) vaginal discharge

  within 72 hours last tampon use

• Vaginal pH

  Vaginal pH

  within 72 hours last tampon use

Secondary Outcomes (2)

• Subject Comfort Diary

  4 months

• Subject Comfort Questionnaire

  4 months

Study Arms (4)

Marketed Tampon D

SHAM COMPARATOR

Regular absorbency tampon

Device: tampon D

Marketed Tampon M

SHAM COMPARATOR

Regular absorbency tampon

Device: tampon M

Marketed Tampon T

SHAM COMPARATOR

Regular absorbency tampon

Device: tampon T

Marketed Tampon V

SHAM COMPARATOR

Regular absorbency tampon

Device: tampon V

Interventions

tampon D DEVICE

regular absorbency tampon

Marketed Tampon D

tampon M DEVICE

regular absorbency tampon

Marketed Tampon M

tampon T DEVICE

regular absorbency tampon

Marketed Tampon T

tampon V DEVICE

regular absorbency tampon

Marketed Tampon V

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• signed the Informed Consent;
• female, between 18 and 55 years of age;
• agree to practice abstinence or use an effective form of birth control (e.g. intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or constant use of condom) for at least the past 4 months and willing to continue throughout the study or have had a tubal ligation or your partner has had a vasectomy at least 4 months before being enrolled in the study;
• be in generally good health without clinically significant disease as determined by investigator or designee based on medical history and vaginal exam;
• for at least the last 4 months, have a consistent menstrual cycle lasting 21-35 days with menstrual bleeding lasting at least 3 days' duration;
• primarily use tampons for their feminine protection needs during their periods (may use provided pads and/or pantiliners as back-up to tampon);
• typically use Regular (6-9 grams) absorbency tampons for the majority of their period,
• wears tampons during menstruation with no history of abnormal discomfort;
• last pap smear was normal in the past 3 years or a normal pap with a negative HPV in the past 5 years (age 18-21 does NOT need a PAP if they have never been sexually active), per standard of care (per ACOG guidelines), (self-reported);
• agree to refrain from vaginal intercourse within 48 hours of each vaginal exam scheduled visit;
• agree to refrain from showering within twelve (12) hours or bathing within twenty-four (24) hours (1 day) of each visit (except Visit 2);
• agree to refrain from using douching substances, feminine hygiene products, and to not apply powders, perfumes, wipes, lotions, creams, or emollients to their genital area 48 hours prior to the screening visit and through the completion of the study, if accepted to participate in the study;
• agree to refrain from taking anti-inflammatory, antihistamine and/or, steroid systemic and/or topical, (including new hormonal contraceptives) medications until they have completed the study (e.g. Advil, Motrin, Benadryl, etc.);
• agree to only use the tampons, pads and pantiliners supplied at each study visit for her menstrual protection while participating in this study;
• be willing and able to comply with the study requirements;

You may not qualify if:

• have a menstrual abnormality with in the last 4 months (such as oligomenorrhea or amenorrhea);
• has had a vaginal delivery in the last 6 months;
• had vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion in the last 6 months;
• are pregnant (per urine pregnancy test at screening), or intend to become pregnant in the next 5 months;
• have a history of Toxic Shock Syndrome (TSS);
• have a history of heart valve replacement;
• have had an abnormal Pap in either of your last 2 Pap Smears;
• have taken steroids (systemic and/or topical), corticosteroids, antihistamines, and/or anti-inflammatories within the past seven days (excludes hormonal contraception);
• have a history of immunosuppressive drug therapy, chemotherapy, or radiation therapy;
• have uncontrolled and/or unstable diabetes (exception...stable dose of Diabetic medication for at least 6 months prior to enrollment) in the opinion of the Investigator;
• have a vulvar piercing;
• have a history of genital herpes;
• within the last 6 months have had endometrial disease/uterine fibroids with symptoms of heavy menstrual flow (super plus tampon absorbency use) and/or severe menstrual cramping;
• have you been diagnosed with a current medical condition which might compromise the immune system functions; including cancer, anemia, leukopenia, leukocyte function deficiency, malnutrition, or chemical dependence (e.g. opiates, marijuana etc.) (self-reported);
• have clinically diagnosed genital warts, lesions, and/or vaginal infections (such as bacterial vaginosis (BV), Candida spp., Trichomonas vaginalis) at the screening visit;

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Synexus-US

Cincinnati, Ohio, 45236, United States

Location

Related Publications (1)

• Hochwalt AE, Abbinante-Nissen JM, Bohman LC, Hattersley AM, Hu P, Streicher-Scott JL, Teufel AG, Woeller KE. The safety assessment of tampons: illustration of a comprehensive approach for four different products. Front Reprod Health. 2023 Jun 20;5:1167868. doi: 10.3389/frph.2023.1167868. eCollection 2023.

  PMID: 37408999 DERIVED

Results Point of Contact

• Title: Jan Streicher-Scott, PhD, RPh
• Organization: Procter & Gamble Co

streicherscott.jl@pg.com

513-634-5584

Study Officials

• Michael Noss, MD

  Site Medical Director

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 27, 2018
• Study Start: January 16, 2018
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: August 26, 2019
• Results First Posted: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)