A Single-center Study Designed to Evaluate the Safety and Efficacy of Tulipon

A Single-center Study Designed to Evaluate the Safety and Efficacy of a New Hygienic Device, Tulipon, in Adult Females With Normal Monthly Menstruation

Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.

Study Overview

• Status: Withdrawn
• Conditions: Safety Issues
• Intervention / Treatment: Device: tulipon

Detailed Description

Subjects use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult females with normal monthly menstruation.

Description

Inclusion Criteria:

1. Women aged 18-45 years
2. Regular menstrual cycles (21-35 days)
3. Uses tampons every month for the last 2 months to handle their monthly bleeding.
4. Active Bleeding lasts at least 3 days
5. Willing not to change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
6. Non-pregnant, with no intentions to get pregnant during the clinical trial
7. Willing to use pads provided thought the study only for the duration of this study
8. Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
9. Signed written informed consent form (ICF) to participate in the study

Exclusion Criteria:

1. Pregnant or lactating women
2. Gave birth less than a 12 month prior to the study.
3. Virgin
4. Using medications to manage pain during active bleeding
5. Using intrauterine device or intrauterine device with hormones (Mirena)
6. Had experienced Toxic shock syndrome (TSS)
7. Previous diagnosis of primary or secondary dysmenorrhea
8. Previous diagnosis of endometriosis
9. Experiences urinary incontinence
10. Suffers from uterus or urine prolapse
11. Abnormal findings following the gynecological exam
12. Subjects with a known or suspected sensitivity to any of the device materials (Polyethylene, Polyurethane, Nylon, Cotton)
13. Been through a vaginal operation in the last 6 months prior to the study.
14. Participation in current or recent clinical trial within 30 days prior to baseline visit

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and efficacy of the Tulipon.	We will take vaginal cultures to show no vaginal infection. By questionnaire we will find out about leakage of period blood from the Tulipon.	1 month

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Gals Bio Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Tulipon-HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No