Back to resultsAnastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
anastrazole
GnRH analog alone
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring endometriosis recurrence, pelvic pain, aromatase inhibitor
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
- Cerm-Hungaria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
anastrazole
GnRH analog alone
Arm Description
women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months
women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg
Outcomes
Primary Outcome Measures
disease free time
time without pain symptoms due to the disease recurrence
Secondary Outcome Measures
time of pain disappearance
time needed during treatment to improve pain symptoms
Full Information
NCT ID
NCT01769781
First Posted
January 15, 2013
Last Updated
April 25, 2016
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy
1. Study Identification
Unique Protocol Identification Number
NCT01769781
Brief Title
Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence
Official Title
Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide).
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate 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. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
endometriosis recurrence, pelvic pain, aromatase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anastrazole
Arm Type
Experimental
Arm Description
women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months
Arm Title
GnRH analog alone
Arm Type
Active Comparator
Arm Description
women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg
Intervention Type
Drug
Intervention Name(s)
anastrazole
Intervention Description
combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months
Intervention Type
Drug
Intervention Name(s)
GnRH analog alone
Intervention Description
treatment for three months with GnRH analog (leuprolide acetate) alone
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 pain disappearance
Description
time needed during treatment to improve 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
18 Years
Maximum Age & Unit of Time
50 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
CERM-HUNGARIA
Official's Role
Study Chair
Facility Information:
Facility Name
Cerm-Hungaria
City
Rome
ZIP/Postal Code
00153
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence
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