Degarelix in the Treatment of Endometriosis Recurrence

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor:
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier:
NCT01712763
First received: October 18, 2012
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

The long acting GnRH antagonist degarelix 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: degarelix
Drug: goserelin
Phase 3

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 With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence

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 disappearance pain [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    time needed during treatment to improve the 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: 100
Study Start Date: November 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix
50 women will be treated with degarelix 80mg in one administration
Drug: degarelix
50 women will be treated with degarlix 80 mg, in only one administration covering three months
Other Name: firmagon
Active Comparator: Goserelin
goserelin 3.6mg monthly for three months
Drug: goserelin
50 women will be treated with decapeptyl 3.6 every month for three months
Other Name: decapeptyl

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. The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.

  Eligibility

Ages Eligible for Study:   20 Years to 45 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: NCT01712763

Contacts
Contact: MARCO SBRACIA, MD +39065810461 marcandrea@hotmail.com
Contact: FABIO SCARPELLINI, MD +39068848013 quelidebercia@hotmail.com

Locations
Italy
Cerm-Hungaria Recruiting
Rome, Italy, 00153
Contact: MARCO SBRACIA, MD    +39065810461    marcandrea@hotmail.com   
Contact: FABIO SCARPELLINI, MD    +39068848013    quelidebercia@hotmail.com   
Principal Investigator: MARCO SBRACIA, MD         
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Investigators
Study Chair: MARCO SBRACIA, MD Centre for Endocrinology and Reproductive Medicine, Italy
  More Information

No publications provided

Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier: NCT01712763     History of Changes
Other Study ID Numbers: C06/2012
Study First Received: October 18, 2012
Last Updated: December 2, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Centre for Endocrinology and Reproductive Medicine, Italy:
Endometriosis
long acting GnRH antagonist
Degarelix
Recurrence
Pelvic Pain

Additional relevant MeSH terms:
Endometriosis
Recurrence
Genital Diseases, Female
Disease Attributes
Pathologic Processes
Goserelin
Triptorelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014