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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix | Experimental | 180 women will be treated with degarelix 120mg in one administration |
|
| leuprolide acetate 11.25 mg/ml | Active Comparator | 180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| degarelix | Drug | 180 women will be treated with degarlix 120 mg, in only one administration covering three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease free time | time without pain symptoms due to the disease recurrence | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| time of disappearance pain | time needed during treatment to improve the pain symptoms | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of endometriosis lesions | endometriosis lesions regression during treatment evidenced by MRI scan | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARCO SBRACIA, MD | Centre for Endocrinology and Reproductive Medicine, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albania Spitali Amerikan | Tirana | Albania | ||||
| Nadezda Women's Health Hospital |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D012008 | Recurrence |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Leuprolide Acetate 11.25 MG/ML (Enantone 11,25) | Drug | 180 women will be treated with leuprolide acetate11.25 only once covering three months |
|
|
| Sofia |
| Bulgaria |
| Cerm-Hungaria | Rome | 00153 | Italy |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |