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Degarelix in the Treatment of Endometriosis Recurrence

This study has been completed.
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy Identifier:
First received: October 18, 2012
Last updated: April 25, 2016
Last verified: April 2016
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
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

Enrollment: 100
Study Start Date: November 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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.

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Genders 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: NCT01712763

Rome, Italy, 00153
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Study Chair: MARCO SBRACIA, MD Centre for Endocrinology and Reproductive Medicine, Italy
  More Information

Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy Identifier: NCT01712763     History of Changes
Other Study ID Numbers: C06/2012 
Study First Received: October 18, 2012
Last Updated: April 25, 2016
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Triptorelin Pamoate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on October 28, 2016