Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378489
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia A Cohort Study
Sponsor:
University of the Philippines
Organization:
University of the Philippines
Study Overview
Official Title:
The Etonogestrel Contraceptive Implant for Treatment of Endometrial Hyperplasia Without Atypia A Single-arm Open-label Longitudinal Study in a Government Hospital in the Philippines
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Endometrial hyperplasia without atypia is a condition in which the endometrium the lining of the uterus becomes abnormally thick Although endometrial hyperplasia without atypia is not cancer it can lead to endometrial cancer in 1-3 of women This disease is treated by giving progestins The optimal route dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now However several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia The other common medications used are the oral progestins medroxyprogesterone MPA and norethisterone acetate NETA
The etonogestrel implant Implant NXT has been approved for contraceptive use by the US FDA in 2006 The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia Off-label use of the implant for adrnomyosis endometriosis and chronic pelvic pain has already been described in various studies However its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet The researchers propose to use the etonogestrel implant Implant NXT as novel treatment for endometrial hyperplasia without atypia The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant
The etonogestrel implant Implant NXT has been approved for contraceptive use by the US FDA in 2006 The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia Off-label use of the implant for adrnomyosis endometriosis and chronic pelvic pain has already been described in various studies However its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet The researchers propose to use the etonogestrel implant Implant NXT as novel treatment for endometrial hyperplasia without atypia The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None