Skip to content

Trial · Interventional

Active, not recruitingPhase 4Registry data

Effect of a GnRH Analog on Hepatic Steatosis

Short name EndomMASLD

NCTNCT06523530 (opens ClinicalTrials.gov in a new tab)Other id5221
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
62 participants (estimated)
Sponsor
Aristotle University Of Thessaloniki · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Greece

Start
26 Nov 2024
Primary completion
Apr 2027 (estimated)
Completion
Oct 2027 (estimated)
First posted
26 Jul 2024
Last update posted
23 Jul 2026
Conditions
Metabolic Dysfunction-Associated Steatotic Liver Disease · Nonalcoholic Fatty Liver · Endometriosis

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025202620272028
  1. Ph 4

    EndomMASLD

    NCT06523530

    26 Nov 2024 to est. Oct 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Goserelin Acetate 3.6 mg inj, implantDrug

Arms2

  • Experimental

    Goserelin

    31 women with histologically confirmed endometriosis will receive goserelin acetate post-surgically.

  • No intervention

    Control

    31 women with histologically confirmed endometriosis will not receive pharmacological treatment post-surgically.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Hepatic steatosis

    Time frame · 6 months

    Registry description

    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

  2. Hepatic fibrosis

    Time frame · 6 months

    Registry description

    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.

Secondary outcomes(20)

  1. Liver function tests I - ALT and AST

    Time frame · 6 months

    Registry description

    Between-within group interactions will be performed for each of the following parameters: Alanine aminotransferase (ALT; IU/l), aspartate aminotransferase (AST; IU/l); ALT to AST ratio will be calculated

  2. Liver function tests II - γGT

    Time frame · 6 months

    Registry description

    Between-within group interactions will be performed for: γ-glutamyltransferase (GGT; IU/l)

  3. Insulin resistance

    Time frame · 6 months

    Registry description

    Between-within group interactions will be performed for Homeostasis Model Assessment - Insulin Resistance (HOMA-IR), which is calculated by the formula: fasting glucose (mg/dl) × insulin (mU/l)/405, and is an index of insulin resistance; higher score indicates greater insulin resistance.

  4. Lipid profile

    Time frame · 6 months

    Registry description

    Between-within group interactions will be performed for each of the following parameters: Total cholesterol (TC; mg/dL) Triglycerides (TG; mg/dL) High-density lipoprotein cholesterol (HDL-C; mg/dL) 4. Low-density lipoprotein cholesterol (LDL-C) LDL-C (mg/dL) is calculated by the formula: TC (mg/dl) - HDL-C (mg/dl) - TG (mg/dl)/5.

  5. Non-invasive hepatic steatosis index I - Fatty Liver Index (FLI)

    Time frame · 6 months

    Registry description

    FLI is calculated by the formula \[(e0.953 × Loge (TG, mg/dL) + 0.139×BMI (kg/m2) + 0.718× Loge (GGT, U/L) + 0.053 × waist circumference (cm) -15.745) / (1 + e0.953 × Loge (TG, mg/dL) + 0.139×BMI (kg/m2) + 0.718×Loge (GGT, U/L) + 0.053 × waist circumference (cm) -15.745)\] × 100. Between-within group interactions will be performed.

  6. Non-invasive hepatic steatosis index II - Hepatic Steatosis Index (HSI)

    Time frame · 6 months

    Registry description

    HSI is calculated by the formula: 8 \* ALT (U/L) / AST (U/L) + BMI (kg/m2) + 2 \[if type 2 diabetes melitus (T2DM)\] + 2 (if female). Between-within group interactions will be performed.

  7. Non-invasive hepatic steatosis index III - Triglyceride/Glucose Index (TyG)

    Time frame · 6 months

    Registry description

    TyG is calculated by the formula: Ln\[TG (mg/dL) \* Glu (mg/dL) / 2\]. Between-within group interactions will be performed.

  8. Non-invasive hepatic steatosis index IV - Tyg-BMI

    Time frame · 6 months

    Registry description

    Tyg-BMI is calculated by the formula: TyG \* BMI (kg/m2). Between-within group interactions will be performed.

  9. Non-invasive hepatic steatosis indices V - NAFLD test

    Time frame · 6 months

    Registry description

    NAFLD test is calculated by the formula: -0.695 + 0.031 \* BMI (kg/m2) + 0.003 \* TC (mg/dL) + 0.014 \* ALT (U/L) + 0.025 \* C-reactive protein (CRP) (mg/dL). Between-within group interactions will be performed.

  10. Non-invasive hepatic steatosis index VI - Metabolic Score for Insulin Resistance (MetS-IR)

    Time frame · 6 months

    Registry description

    MetS-IR is calculated by the formula: Ln\[2 \* Glu (mg/dL) + TG (mg/dL)\] \* BMI (kg/m2) / Ln\[HDL-C (mg/dL)\]. Between-within group interactions will be performed.

  11. Non-invasive hepatic steatosis index VII - Lipid Accumulation Product index (LAP)

    Time frame · 6 months

    Registry description

    LAP is calculated by the formula: \[WC (cm) - 58\] \* \[TG (mg/dL) / 88.57\]. Between-within group interactions will be performed.

  12. Non-invasive hepatic steatosis index VIII - Liver Fat Score (LFS)

    Time frame · 6 months

    Registry description

    LFS is calculated by the formula: -2.89 + 1.18 (if metabolic syndrome) + 0.45 \* 2 (if T2DM) + 0.15 \* insulin (mU/L) + 0.04 \* AST (U/L) - 0.94 \* AST (U/L) / ALT (U/L). Between-within group interactions will be performed.

  13. Non-invasive hepatic fibrosis index I - NAFLD fibrosis score (NFS)

    Time frame · 6 months

    Registry description

    NFS is calculated by the formula: -1.675 + 0.037 \* age (years) + 0.094 \* BMI (kg/m2) + 1.13 (if impaired fasting glucose or T2DM) + 0.99 \* AST (U/L) / ALT (U/L) - 0.013 \* platelet count \[\*10(9)/L\] - 0.66 \* albumin (g/dL). Between-within group interactions will be performed.

  14. Non-invasive hepatic fibrosis index II - Fibrosis-4 index (FIB-4)

    Time frame · 6 months

    Registry description

    FIB-4 is calculated by the formula: age (years) \* AST (U/L) / {platelet count \[\*10(9)/L\] \* √ALT (U/L)}. Between-within group interactions will be performed.

  15. Non-invasive hepatic fibrosis index III - AST-to-Platelet Ratio Index (APRI)

    Time frame · 6 months

    Registry description

    APRI is calculated by the formula: AST (U/L) / upper limit of normal \* 100 / platelet count \[\*10(9)/L\]. Between-within group interactions will be performed.

  16. Non-invasive hepatic fibrosis index IV - Metabolic dysfunction-Associated Fibrosis Score (MAF-5)

    Time frame · 6 months

    Registry description

    MAF-5 is calculated by the formula: -11.3674 + 0.0282 \* WC (cm) - 0.1761 \* BMI (kg/m2) + 0.0019 \* WC (cm) \* BMI (kg/m2) + 2.0762 (if T2DM) + 2.9207 \* Ln\[AST (U/L)\] - 0.0059 \* platelet count \[\*10(9)/L\]. Between-within group interactions will be performed.

  17. Adiponectin

    Time frame · 6 months

    Registry description

    Adiponectin is measured in μg/mL. Between-within group interactions will be performed.

  18. Leptin

    Time frame · 6 months

    Registry description

    Leptin is measured in ng/mL. Between-within group interactions will be performed.

  19. Tumor Necrosis Factor-α (TNF-α)

    Time frame · 6 months

    Registry description

    TNF-a is measured in pg/mL. Between-within group interactions will be performed.

  20. Sex hormones I - Estradiol

    Time frame · 6 months

    Registry description

    Estradiol is measured in pg/mL. Between-within group interactions will be performed.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

5 results

Dienogest compared with gonadotropin-releasing hormone agonist after conservative surgery for endometriosis.

Takaesu et al. 2016The journal of obstetrics and gynaecology researchcited by 38

PMID 27225336DOI 10.1111/jog.13023PUB-27225336

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * women of reproductive age * diagnosis of endometriosis. The disease is suspected by patient's individual history (chronic pelvic pain, dyspareunia or/and dysmenorrhea) and the ultrasonographic imaging (chocolate cysts). The diagnosis is confirmed histologically, after laparoscopic surgical treatment and biopsy sampling, which will be interpreted by an independent blinded pathologist. * use of contraceptives, which is the first line treatment, is contraindicated or the patient does not consent to receive contraceptives, due to personal preferences. * written informed consent to participate to the study Exclusion Criteria: * mean ethanol consumption \>10 g/day * history of other chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis and overlap syndromes, drug-induced liver injury, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency) * liver cirrhosis * any malignancy * chronic kidney disease * uncontrolled hypothyroidism or hyperthyroidism * severe sexual hormone disorders (congenital adrenaline hyperplasia, Down syndrome, Turner syndrome). * use of the following medications within a 12-month period before baseline, which are associated with drug-induced liver injury (DILI): interferon, tamoxifen, amiodarone, aloperidin, glucocorticoids, hormone replacement therapy, contraceptives, anabolic steroids, any medication against tuberculosis, epilepsy or viruses, methotrexate, parenteral nutrition * use of the following medications within a 12-month period before baseline, which are probably associated with improvement in hepatic steatosis: vitamin E, pioglitazone, insulin, glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium- glucose co-transporter-2 inhibitors (SGLT-2i), orlistat, ursodeoxycholic acid * use of any GnRH agonist or antagonist within a 12-month period before baseline

PepBank is a research reference. Talk to a doctor before you use any peptide.