MedPath

Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

Phase 4
Completed
Conditions
Endometriosis
Interventions
Drug: anastrazole
Registration Number
NCT01769781
Lead Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy
Brief Summary

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.

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. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
70
Inclusion Criteria
  • women affected by endometriosis showing recurrence of pain symptoms, previous surgery for endometriosis
Exclusion Criteria
  • presence of other systemic diseases

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
anastrazoleanastrazolewomen with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months
GnRH analog aloneGnRH analog alonewomen with endometriosis recurrence will be treated with leuprolide acetate 11.25mg
Primary Outcome Measures
NameTimeMethod
disease free time24 months

time without pain symptoms due to the disease recurrence

Secondary Outcome Measures
NameTimeMethod
time of pain disappearance24 months

time needed during treatment to improve pain symptoms

Trial Locations

Locations (1)

Cerm-Hungaria

🇮🇹

Rome, Italy

© Copyright 2025. All Rights Reserved by MedPath