Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT06019533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-21
First Post:
2023-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Sponsor:
Chemo Research
Organization:
Study Overview
Official Title:
A Multicentre, Single Arm Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy tests, gynaecological examinations, laboratory tests and a quality of life questionnaire. Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only). The women will be provided with an e-diary app for their smartphone, to record IP use and vaginal bleeding.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: