Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523530
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Effect of a GnRH Analog on Hepatic Steatosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of the Pharmacological Cessation of Menstruation With a GnRH Analog on Hepatic Steatosis in Women With Endometriosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EndomMASLD
Brief Summary:
Menopause increases the risk of metabolic dysfunction-associated steatotic liver disease MASLD possibly owing to the abrupt lack of estrogen Gonadotropin-releasing hormone GnRH treatment in endometriosis is regarded as a model of pharmaceutical menopause Thus the effect of goserelin acetate a GnRH analog that results in transient menopause on hepatic steatosis and fibrosis will be evaluated in this study
Detailed Description:
The prevalence of metabolic dysfunction-associated steatotic liver disease MASLD which until recently was known as nonalcoholic fatty liver disease NAFLD has risen to 30 of the global adult general population whereas the pharmaceutical interventions against it remain limited Owing to the epidemiologic and pathophysiologic association of MASLD with obesity type 2 diabetes mellitus dyslipidemia and arterial hypertension the diagnostic criteria for MASLD are similar to those of the metabolic syndrome
Menopause has been associated with higher MASLD prevalence with the lack of estrogen being a very plausible pathogenetic contributor to this liver disease Other pathogenetic contributors of MASLD including abdominal obesity increase in insulin resistance IR and dysmetabolism of carbohydrates and lipids are aggravated after menopause thus adversely contributing to the pathogenesis of MASLD Regarding the effect of the lack of estrogen on the liver most to date data are derived from experimental studies largely showing a favoring effect on MASLD Epidemiological studies have also shown menopause as an associate of MASLD However existing clinical studies are mostly observational thereby not being able to show a causative association between menopause and MASLD
Gonadotropin-releasing hormone GnRH treatment in disorders such as endometriosis can be regarded as a model of pharmaceutical menopause More specifically GnRH analogs like goserelin acetate lead to pharmaceutical menopause by suppressing the axis hypothalamus-pituitary-ovaries thus causing an iatrogenic reversible ovarian cessation which lasts as long as the use of GnRH The adverse effects of GnRH are generally mild and reversible after their discontinuation
This is a prospective interventional non-randomized study which aims to evaluate the effect of goserelin acetate on hepatic steatosis in women with histologically confirmed endometriosis compared with women with endometriosis that will not receive pharmacological treatment post-surgically
Menopause has been associated with higher MASLD prevalence with the lack of estrogen being a very plausible pathogenetic contributor to this liver disease Other pathogenetic contributors of MASLD including abdominal obesity increase in insulin resistance IR and dysmetabolism of carbohydrates and lipids are aggravated after menopause thus adversely contributing to the pathogenesis of MASLD Regarding the effect of the lack of estrogen on the liver most to date data are derived from experimental studies largely showing a favoring effect on MASLD Epidemiological studies have also shown menopause as an associate of MASLD However existing clinical studies are mostly observational thereby not being able to show a causative association between menopause and MASLD
Gonadotropin-releasing hormone GnRH treatment in disorders such as endometriosis can be regarded as a model of pharmaceutical menopause More specifically GnRH analogs like goserelin acetate lead to pharmaceutical menopause by suppressing the axis hypothalamus-pituitary-ovaries thus causing an iatrogenic reversible ovarian cessation which lasts as long as the use of GnRH The adverse effects of GnRH are generally mild and reversible after their discontinuation
This is a prospective interventional non-randomized study which aims to evaluate the effect of goserelin acetate on hepatic steatosis in women with histologically confirmed endometriosis compared with women with endometriosis that will not receive pharmacological treatment post-surgically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None