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Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01769781
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : April 27, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: anastrazole Drug: GnRH analog alone Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide).
Study Start Date : January 2013
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01769781     History of Changes
Other Study ID Numbers: CR013-01
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Fabio Scarpellini, 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
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents