Degarelix in the Treatment of Endometriosis Recurrence

March 4, 2024 updated by: Centre for Endocrinology and Reproductive Medicine, Italy

Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Albania
      • Tirana, Albania
        • Albania Spitali Amerikan
  • Bulgaria
      • Sofia, Bulgaria
        • Nadezda Women's Health Hospital
  • Italy
      • Rome, Italy, 00153
        • Cerm-Hungaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of other systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Degarelix
180 women will be treated with degarelix 120mg in one administration
Drug: degarelix
180 women will be treated with degarlix 120 mg, in only one administration covering three months
Other Names:
  • firmagon
Active Comparator: leuprolide acetate 11.25 mg/ml
180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months
Drug: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)
180 women will be treated with leuprolide acetate11.25 only once covering three months
Other Names:
  • Enantone 11.25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free time
Time Frame: 24 months
time without pain symptoms due to the disease recurrence
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of disappearance pain
Time Frame: 24 months
time needed during treatment to improve the pain symptoms
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of endometriosis lesions
Time Frame: 24 months
endometriosis lesions regression during treatment evidenced by MRI scan
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Investigators

  • Study Chair: MARCO SBRACIA, MD, Centre for Endocrinology and Reproductive Medicine, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimated)

October 24, 2012

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C06/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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