A Phase 3 interventional study of degarelix and Leuprolide Acetate 11.25 MG/ML (Enantone 11,25) in Endometriosis, sponsored by Centre for Endocrinology and Reproductive Medicine, Italy. Completed at 3 sites in 3 countries. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Centre for Endocrinology and Reproductive Medicine, Italy · Phase 3, Interventional, and Treatment
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.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's enrollment of 360 is above the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Centre for Endocrinology and Reproductive Medicine, Italy is the lead sponsor of 9 studies on the registry; none are open to participants now.
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180 women will be treated with degarelix 120mg in one administration
Drug: degarelix
180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months
Drug: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)
180 women will be treated with degarlix 120 mg, in only one administration covering three months
Also known as: firmagon
Drug page: Leuprolide
180 women will be treated with leuprolide acetate11.25 only once covering three months
Also known as: Enantone 11.25
disease free time
time without pain symptoms due to the disease recurrence
Time frame: 24 months
time of disappearance pain
time needed during treatment to improve the pain symptoms
Time frame: 24 months
reduction of endometriosis lesions
endometriosis lesions regression during treatment evidenced by MRI scan
Time frame: 24 months
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Degarelix
Centre for Endocrinology and Reproductive Medicine, Italy