Effect of the Pharmacological Cessation of Menstruation with a GnRH Analog on Hepatic Steatosis in Women with Endometriosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Greece
1st Department of Obstetrics and Gynecology, School of Medicine, Aristotle University of Thessaloniki
RECRUITING
Thessaloniki
424 General Military Hospital
RECRUITING
Thessaloniki
Contact Information
Primary
Stergios A Polyzos, MD, PhD
spolyzos@auth.gr
2310999316
Backup
Dimitrios A Anastasilakis, MD, PhDc
dimitanast@auth.gr
6932238231
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2027-04
Participants
Target number of participants: 62
Treatments
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.
Sponsors
Leads: Aristotle University Of Thessaloniki
Collaborators: 424 General Military Hospital

This content was sourced from clinicaltrials.gov