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

Withdrawn

• Conditions: Safety Issues

• Registration Number: NCT04268758
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Status Verified: 2020-04
• Study Start: 2021-06-01
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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