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Completed

NCT Number: NCT01712763

Degarelix in the Treatment of Endometriosis Recurrence

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.

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Key information

Conditions

Endometriosis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Recurrence Signs and Symptoms Urogenital Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Albania Spitali Amerikan, Tirana, Albania

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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. 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.

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

degarelix

Drug

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

Other names: firmagon

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

Drug

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

Other names: Enantone 11.25

Primary outcomes

  1. disease free time

    Time frame: 24 months

    time without pain symptoms due to the disease recurrence

Secondary outcomes

  1. time of disappearance pain

    Time frame: 24 months

    time needed during treatment to improve the 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 With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2012
Registry last updated
Mar 6, 2024

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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