Back to resultsDegarelix in the Treatment of Endometriosis Recurrence
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
degarelix
goserelin
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, long acting GnRH antagonist, Degarelix, Recurrence, Pelvic Pain
Eligibility Criteria
Inclusion Criteria:
- women affected by endometriosis showing recurrence of pain symptoms
- previous surgery for endometriosis
Exclusion Criteria:
- presence of other systemic diseases
Sites / Locations
- Albania Spitali Amerikan
- Nadezda Women's Health Hospital
- Cerm-Hungaria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Degarelix
Goserelin
Arm Description
180 women will be treated with degarelix 80mg in one administration
180 women will be treated with goserelin 3.6mg monthly for three months
Outcomes
Primary Outcome Measures
disease free time
time without pain symptoms due to the disease recurrence
Secondary Outcome Measures
time of disappearance pain
time needed during treatment to improve the pain symptoms
Full Information
NCT ID
NCT01712763
First Posted
October 18, 2012
Last Updated
February 10, 2022
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy
1. Study Identification
Unique Protocol Identification Number
NCT01712763
Brief Title
Degarelix in the Treatment of Endometriosis Recurrence
Official Title
Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, long acting GnRH antagonist, Degarelix, Recurrence, Pelvic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Degarelix
Arm Type
Experimental
Arm Description
180 women will be treated with degarelix 80mg in one administration
Arm Title
Goserelin
Arm Type
Active Comparator
Arm Description
180 women will be treated with goserelin 3.6mg monthly for three months
Intervention Type
Drug
Intervention Name(s)
degarelix
Other Intervention Name(s)
firmagon
Intervention Description
180 women will be treated with degarlix 80 mg, in only one administration covering three months
Intervention Type
Drug
Intervention Name(s)
goserelin
Other Intervention Name(s)
decapeptyl
Intervention Description
180 women will be treated with decapeptyl 3.6 every month for three months
Primary Outcome Measure Information:
Title
disease free time
Description
time without pain symptoms due to the disease recurrence
Time Frame
24 months
Secondary Outcome Measure Information:
Title
time of disappearance pain
Description
time needed during treatment to improve the pain symptoms
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
reduction of endometriosis lesions
Description
endometriosis lesions regression during treatment evidenced by MRI scan
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women affected by endometriosis showing recurrence of pain symptoms
previous surgery for endometriosis
Exclusion Criteria:
presence of other systemic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCO SBRACIA, MD
Organizational Affiliation
Centre for Endocrinology and Reproductive Medicine, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Albania Spitali Amerikan
City
Tirana
Country
Albania
Facility Name
Nadezda Women's Health Hospital
City
Sofia
Country
Bulgaria
Facility Name
Cerm-Hungaria
City
Rome
ZIP/Postal Code
00153
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Degarelix in the Treatment of Endometriosis Recurrence
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