Degarelix in the Treatment of Endometriosis Recurrence

Centre for Endocrinology and Reproductive Medicine, Italy

Status and phase: Completed; Phase 3

Conditions: Endometriosis

Treatments: Drug: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25); Drug: degarelix

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01712763

C06/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women affected by endometriosis showing recurrence of pain symptoms
• previous surgery for endometriosis

Exclusion criteria

• presence of other systemic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Degarelix

Experimental group

Description:

180 women will be treated with degarelix 120mg in one administration

Treatment:

Drug: degarelix

leuprolide acetate 11.25 mg/ml

Active Comparator group

Description:

180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months

Treatment:

Drug: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)