NCT01712763

Degarelix in the Treatment of Endometriosis Recurrence

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy · Network
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	degarelix	180 women will be treated with degarlix 120 mg, in only one administration covering three months
DRUG	Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)	180 women will be treated with leuprolide acetate11.25 only once covering three months

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2012-10-24
• Last updated: 2024-03-06

Locations

3 sites across 3 countries: Albania, Bulgaria, Italy