Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

Centre for Endocrinology and Reproductive Medicine, Italy

Status and phase: Completed; Phase 4

Conditions: Endometriosis

Treatments: Drug: anastrazole; Drug: GnRH analog alone

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01769781

CR013-01

Details and patient eligibility

About

The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate 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. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 50 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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70 participants in 2 patient groups

anastrazole

Experimental group

Description:

women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months

Treatment:

Drug: anastrazole

GnRH analog alone

Active Comparator group

Description:

women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg

Treatment:

Drug: GnRH analog alone