Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01769781

Enrollment

Registered

2013-01-17

Start date

2013-01-31

Completion date

2015-07-31

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

endometriosis recurrence, pelvic pain, aromatase inhibitor

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.

Interventions

DRUGanastrazole

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

DRUGGnRH analog alone

treatment for three months with GnRH analog (leuprolide acetate) alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* presence of other systemic diseases

Design outcomes

Primary

Measure	Time frame	Description
disease free time	24 months	time without pain symptoms due to the disease recurrence

Secondary

Measure	Time frame	Description
time of pain disappearance	24 months	time needed during treatment to improve pain symptoms

Other

Measure	Time frame	Description
reduction of endometriosis lesions	24 months	endometriosis lesions regression during treatment evidenced by MRI scan

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026