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Completed

NCT Number: NCT01769781

Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cerm-Hungaria

Rome, 00153, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • presence of other systemic diseases

Treatment and study plan

Anastrazole

Drug

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

GnRH analog alone

Drug

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

Primary outcomes

  1. disease free time

    Time frame: 24 months

    time without pain symptoms due to the disease recurrence

Secondary outcomes

  1. time of pain disappearance

    Time frame: 24 months

    time needed during treatment to improve pain symptoms

Other outcomes

  1. reduction of endometriosis lesions

    Time frame: 24 months

    endometriosis lesions regression during treatment evidenced by MRI scan

Sponsors and collaborators

Lead sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Network

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 17, 2013
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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