Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390904
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-22
Brief Title:
GnRHa Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients
Sponsor:
Xiaojun Chen
Organization:
Fudan University
Study Overview
Official Title:
Gonadotropin-releasing Hormone Agonist GnRHa Plus Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients With Conservative Treatment
Status:
RECRUITING
Status Verified Date:
2024-07
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:
To investigate the efficacy of Gonadotropin-releasing Hormone Agonist GnRHa plus letrozole in obese progestin-insensitive atypical endometrial hyperplasia EAH patients
Detailed Description:
There were more and more women with early endometrioid endometrial cancer EEC and atypical endometrial hyperplasia EAH who want to preserve fertility
Approximately 70 to 80 of females who meet the criteria for conservation treatment are able to achieve complete response CR after progestin therapy with a median time of 6-7 months but about 20 to 30 of patients get no response or need to take longer time to achieve remission over one year With long duration of treatment there will be more side effects such as weight gain impaired liver function endometrial injury ovarian reserve inhibition etc which will decrease the efficacy of conservative treatment Previous researches had shown that Gonadotropin-releasing Hormone Agonist GnRHa plus letrozole could be a better second-line treatment for obese progestin-insensitive patients Till now no similar studies were found so the investigators design this study to explore the efficacy of GnRHa plus letrozole in obese progestin-insensitive EAH patients to provide new evidences for improving conservative treatment efficacy The investigators defined obese patients as these with BMI 30kgm2
This will be a single-centred prospective pilot study Patients diagnosed as obese progestin-insensitive EAH by dilatation and curettage DC or hysteroscopy will be enrolled The primary endpoint is cumulative CR rate at 28 weeks of treatment The secondary endpoints include adverse events duration of complete response recurrent rate pregnancy rate and quality of life of patients
Approximately 70 to 80 of females who meet the criteria for conservation treatment are able to achieve complete response CR after progestin therapy with a median time of 6-7 months but about 20 to 30 of patients get no response or need to take longer time to achieve remission over one year With long duration of treatment there will be more side effects such as weight gain impaired liver function endometrial injury ovarian reserve inhibition etc which will decrease the efficacy of conservative treatment Previous researches had shown that Gonadotropin-releasing Hormone Agonist GnRHa plus letrozole could be a better second-line treatment for obese progestin-insensitive patients Till now no similar studies were found so the investigators design this study to explore the efficacy of GnRHa plus letrozole in obese progestin-insensitive EAH patients to provide new evidences for improving conservative treatment efficacy The investigators defined obese patients as these with BMI 30kgm2
This will be a single-centred prospective pilot study Patients diagnosed as obese progestin-insensitive EAH by dilatation and curettage DC or hysteroscopy will be enrolled The primary endpoint is cumulative CR rate at 28 weeks of treatment The secondary endpoints include adverse events duration of complete response recurrent rate pregnancy rate and quality of life of patients
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