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Clinical trial

Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence

ID
Name
C06/2012
Description
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.
Trial arms
Trial start
2012-11-01
Estimated PCD
2016-03-01
Trial end
2016-03-01
Status
Completed
Phase
Early phase I
Treatment
degarelix
180 women will be treated with degarlix 120 mg, in only one administration covering three months
Arms:
Degarelix
Other names:
firmagon
Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)
180 women will be treated with leuprolide acetate11.25 only once covering three months
Arms:
leuprolide acetate 11.25 mg/ml
Other names:
Enantone 11.25
Size
360
Primary endpoint
disease free time
24 months
Eligibility criteria
Inclusion Criteria: * women affected by endometriosis showing recurrence of pain symptoms * previous surgery for endometriosis Exclusion Criteria: * presence of other systemic diseases
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 360, 'type': 'ACTUAL'}}
Updated at
2024-03-06

1 organization

1 product

1 drug

1 indication

Organization
Centre for Endocrinology and Reproductive Medicine
Drug
degarelix
Indication
Endometriosis
Product
Leuprolide Acetate