Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

April 25, 2016 updated by: Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy

Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide).

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.

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. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

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

  • 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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: anastrazole
women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months
Drug: anastrazole
combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months
ACTIVE_COMPARATOR: GnRH analog alone
women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg
Drug: GnRH analog alone
treatment for three months with GnRH analog (leuprolide acetate) alone

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 pain disappearance
Time Frame: 24 months
time needed during treatment to improve 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

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

January 1, 2013

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (ESTIMATE)

January 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013-01

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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