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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04268758
• Other study ID #: Tulipon-HMO-CTIL
• Status: Withdrawn
• Start date: June 1, 2021
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety Issues

Intervention

Device:
• tulipon
Tulipon is a new kind of hygienic device, used to collect the secreted menses during the bleeding phase of the menstruation.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Gals Bio Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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