Degarelix in the Treatment of Endometriosis Recurrence

Phase 3

Completed

• Conditions: Endometriosis
• Interventions: Drug: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25); Drug: degarelix

• Registration Number: NCT01712763
• Lead Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy

Brief Summary

The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.

Detailed Description

Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.

Study Timeline

• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Study Start: 2012-11
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2022-02
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

• women affected by endometriosis showing recurrence of pain symptoms
• previous surgery for endometriosis

Exclusion Criteria

• presence of other systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
leuprolide acetate 11.25 mg/ml	Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)	180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months
Degarelix	degarelix	180 women will be treated with degarelix 120mg in one administration

Primary Outcome Measures

Name	Time	Method
disease free time	24 months	time without pain symptoms due to the disease recurrence

Secondary Outcome Measures

Name	Time	Method
time of disappearance pain	24 months	time needed during treatment to improve the pain symptoms

Trial Locations

Locations (3)

Cerm-Hungaria; 🇮🇹 Rome, Italy

Nadezda Women's Health Hospital; 🇧🇬 Sofia, Bulgaria

Albania Spitali Amerikan; 🇦🇱 Tirana, Albania