Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

Endometriosis Clinical Trial

Official title:

Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769781
• Other study ID #: CR013-01
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2013
• Last updated: April 25, 2016
• Start date: January 2013
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: Centre for Endocrinology and Reproductive Medicine, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• presence of other systemic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Recurrence

Intervention

Drug:
• anastrazole
combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months
• GnRH analog alone
treatment for three months with GnRH analog (leuprolide acetate) alone

Locations

Country	Name	City	State
Italy	Cerm-Hungaria	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Endocrinology and Reproductive Medicine, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	reduction of endometriosis lesions	endometriosis lesions regression during treatment evidenced by MRI scan	24 months	No
Primary	disease free time	time without pain symptoms due to the disease recurrence	24 months	Yes
Secondary	time of pain disappearance	time needed during treatment to improve pain symptoms	24 months	Yes