Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor:
Information provided by (Responsible Party):
Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier:
NCT01769781
First received: January 15, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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
Endometriosis
Drug: anastrazole
Drug: GnRH analog alone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]
    time without pain symptoms due to the disease recurrence


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


Other Outcome Measures:
  • reduction of endometriosis lesions [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    endometriosis lesions regression during treatment evidenced by MRI scan


Estimated Enrollment: 70
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769781

Locations
Italy
Cerm-Hungaria Recruiting
Rome, Italy, 00153
Contact: FABIO SCARPELLINI, MD    +39-3278779064    quelidebercia@hotmail.com   
Contact: MARCO SBRACIA, MD    +39-3479037433    marcandrea@hotmail.com   
Principal Investigator: FABIO SCARPELLINI, MD         
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Investigators
Study Chair: marco sbracia, md CERM-HUNGARIA
  More Information

No publications provided

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
Study First Received: January 15, 2013
Last Updated: September 4, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

Additional relevant MeSH terms:
Endometriosis
Recurrence
Genital Diseases, Female
Disease Attributes
Pathologic Processes
Deslorelin
Anastrozole
Leuprolide
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014