Effect of the Pharmacological Cessation of Menstruation With a GnRH Analog on Hepatic Steatosis in Women With Endometriosis (EndomMASLD)

NCT06523530 Phase 4 RECRUITING

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.

Details

Lead sponsor	Aristotle University Of Thessaloniki
Phase	Phase 4
Status	RECRUITING
Enrolment	62
Start date	2024-11-26
Completion	2027-10

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease
• Nonalcoholic Fatty Liver
• Endometriosis

Interventions

• Goserelin Acetate 3.6 mg inj, implant

Primary outcomes

• Hepatic steatosis — 6 months
  Ultrasound-Guided Attenuation Parameter (UGAP) measured on an ultrasound machine GE Logiq E10s. Between-within group interactions in UGAP UGAP is a non-invasive index based on the attenuation quantification of the ultrasound beam through the hepatic parenchyma, thus used for hepatic steatosis quantification. Cut-off values of ≥ 0.53 dB/cm/MHz, ≥ 0.60 dB/cm/MHz, and ≥ 0.65 dB/cm/MHz have been proposed for the diagnosis of steatosis grade S1, S2, and S3, respectively
• Hepatic fibrosis — 6 months
  Liver stiffness (LS) measured with 2D Shear Wave Elastography (2D SWE) on an ultrasound machine GE Logiq E10s. Between-within group interactions in LS 2D SWE is a non-invasive tool measuring the hepatic parenchyma stiffness, thus indirectly suggesting fibrosis stage (F). Cut-offs values of \<8.27 kPa, 8.27-9.39 kPa, 9.40-11.88 kPa and ≥11.88 kPa have been proposed for F0-F1, F2, F3, and F4, respectively.

Countries

Greece