Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT04268758
Status:
WITHDRAWN
Last Update Posted:
2022-08-04
First Post:
2020-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Single-center Study Designed to Evaluate the Safety and Efficacy of Tulipon
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
logistic and financial issues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: