Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

NCT ID: NCT01769781

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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anastrazole

women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months

Group Type EXPERIMENTAL

anastrazole

Intervention Type DRUG

combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months

GnRH analog alone

women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg

Group Type ACTIVE_COMPARATOR

GnRH analog alone

Intervention Type DRUG

treatment for three months with GnRH analog (leuprolide acetate) alone

Interventions

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anastrazole

combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months

Intervention Type DRUG

GnRH analog alone

treatment for three months with GnRH analog (leuprolide acetate) alone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* presence of other systemic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre for Endocrinology and Reproductive Medicine, Italy

NETWORK

Sponsor Role lead

Responsible Party

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Fabio Scarpellini

PRINCIPAL INVESTIGATOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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marco sbracia, md

Role: STUDY_CHAIR

CERM-HUNGARIA

Locations

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Cerm-Hungaria

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CR013-01

Identifier Type: -

Identifier Source: org_study_id

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