Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
Overview
- Phase
- Phase 3
- Intervention
- degarelix
- Conditions
- Endometriosis
- Sponsor
- Centre for Endocrinology and Reproductive Medicine, Italy
- Enrollment
- 360
- Locations
- 3
- Primary Endpoint
- disease free time
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •women affected by endometriosis showing recurrence of pain symptoms
- •previous surgery for endometriosis
Exclusion Criteria
- •presence of other systemic diseases
Arms & Interventions
Degarelix
180 women will be treated with degarelix 120mg in one administration
Intervention: degarelix
leuprolide acetate 11.25 mg/ml
180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months
Intervention: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)
Outcomes
Primary Outcomes
disease free time
Time Frame: 24 months
time without pain symptoms due to the disease recurrence
Secondary Outcomes
- time of disappearance pain(24 months)