Trials Sponsors Conditions Drugs Pricing

Conditions

Endometriosis Metabolic Dysfunction-Associated Steatotic Liver Disease Nonalcoholic Fatty Liver

Keywords

endometriosisgoserelin acetatehepatic fibrosisMASLDMASHmetabolic dysfunction-associated steatotic liver diseasemetabolic dysfunction-associated steatohepatitisNAFLDNASHnonalcoholic fatty liver diseasenonalcoholic steatohepatitistreatmentmenopause

Outcome Measures

Primary Outcomes (2)

Hepatic steatosis
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
6 months
Hepatic fibrosis
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.
6 months

Study Arms (2)

Goserelin

EXPERIMENTAL

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

Drug: Goserelin Acetate 3.6 mg inj, implant

Control

NO INTERVENTION

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

Interventions

Goserelin Acetate 3.6 mg inj, implantDrug

3.6 mg (1ml) administered subcutaneously once every month for 6 months (totally 6 injections)

Also known as: Zoladex

Goserelin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Aristotle University Of Thessaloniki
Otherlead
424 General Military Hospital
Othercollaborator

Study Sites (2)

424 General Military Hospital

Thessaloniki, Thessaloniki, 56429, Greece

1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki

Thessaloniki, 56403, Greece

Related Publications (13)

Henry L, Paik J, Younossi ZM. Review article: the epidemiologic burden of non-alcoholic fatty liver disease across the world. Aliment Pharmacol Ther. 2022 Sep;56(6):942-956. doi: 10.1111/apt.17158. Epub 2022 Jul 26.
PMID: 35880713BACKGROUND
Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023 Dec 1;78(6):1966-1986. doi: 10.1097/HEP.0000000000000520. Epub 2023 Jun 24.
PMID: 37363821

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseEndometriosisLiver Cirrhosis

Interventions

GoserelinDrug Implants

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFibrosis

Study Officials

Dimitrios A Anastasilakis, MD, PhDc
School of Medicine, Aristotle University of Thessaloniki
STUDY DIRECTOR
Athina I Gkiomisi, MD, PhD
424 General Military Hospital, Thessaloniki, Greece
STUDY DIRECTOR
Dimitrios G Goulis, MD, PhD
School of Medicine, Aristotle University of Thessaloniki
STUDY DIRECTOR
Angelos Daniilidis, MD, PhD
School of Medicine, Aristotle University of Thessaloniki
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor of Pharmacology

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 26, 2024

Study Start

November 26, 2024

Actual (reported)

Primary Completion

Effect of a GnRH Analog on Hepatic Steatosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Goserelin

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Secondary Outcomes (22)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Goserelin

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Secondary Outcomes (22)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations