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Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

This study has been completed.
Information provided by (Responsible Party):
Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy Identifier:
First received: January 15, 2013
Last updated: April 25, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Drug: anastrazole
Drug: GnRH analog alone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide).

Resource links provided by NLM:

Further study details as provided by Centre for Endocrinology and Reproductive Medicine, Italy:

Primary Outcome Measures:
  • disease free time [ Time Frame: 24 months ]
    time without pain symptoms due to the disease recurrence

Secondary Outcome Measures:
  • time of pain disappearance [ Time Frame: 24 months ]
    time needed during treatment to improve pain symptoms

Other Outcome Measures:
  • reduction of endometriosis lesions [ Time Frame: 24 months ]
    endometriosis lesions regression during treatment evidenced by MRI scan

Enrollment: 70
Study Start Date: January 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anastrazole
women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months
Drug: anastrazole
combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months
Active Comparator: GnRH analog alone
women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg
Drug: GnRH analog alone
treatment for three months with GnRH analog (leuprolide acetate) alone

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.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of other systemic diseases
  Contacts and Locations
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Please refer to this study by its identifier: NCT01769781

Rome, Italy, 00153
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Study Chair: marco sbracia, md CERM-HUNGARIA
  More Information

Responsible Party: Fabio Scarpellini, PRINCIPAL INVESTIGATOR, Centre for Endocrinology and Reproductive Medicine, Italy Identifier: NCT01769781     History of Changes
Other Study ID Numbers: CR013-01
Study First Received: January 15, 2013
Last Updated: April 25, 2016

Keywords provided by Centre for Endocrinology and Reproductive Medicine, Italy:
endometriosis recurrence
pelvic pain
aromatase inhibitor

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents processed this record on May 23, 2017