Degarelix in the Treatment of Endometriosis Recurrence

NCT ID: NCT01712763

Last Updated: 2024-03-06

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

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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. 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.

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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Degarelix

180 women will be treated with degarelix 120mg in one administration

Group Type EXPERIMENTAL

degarelix

Intervention Type DRUG

180 women will be treated with degarlix 120 mg, in only one administration covering three months

leuprolide acetate 11.25 mg/ml

180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months

Group Type ACTIVE_COMPARATOR

Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)

Intervention Type DRUG

180 women will be treated with leuprolide acetate11.25 only once covering three months

Interventions

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degarelix

180 women will be treated with degarlix 120 mg, in only one administration covering three months

Intervention Type DRUG

Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)

180 women will be treated with leuprolide acetate11.25 only once covering three months

Intervention Type DRUG

Other Intervention Names

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firmagon Enantone 11.25

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

20 Years

Maximum Eligible Age

45 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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Responsibility Role SPONSOR

Principal Investigators

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MARCO SBRACIA, MD

Role: STUDY_CHAIR

Centre for Endocrinology and Reproductive Medicine, Italy

Locations

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Albania Spitali Amerikan

Tirana, , Albania

Site Status

Nadezda Women's Health Hospital

Sofia, , Bulgaria

Site Status

Cerm-Hungaria

Rome, , Italy

Site Status

Countries

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Albania Bulgaria Italy

Other Identifiers

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C06/2012

Identifier Type: -

Identifier Source: org_study_id

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