We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Degarelix 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: NCT01712763
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : April 27, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Endometriosis Drug: degarelix Drug: goserelin Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
Study Start Date : November 2012
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

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 disappearance pain [ Time Frame: 24 months ]
    time needed during treatment to improve the 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

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 45 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): 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
ClinicalTrials.gov Identifier: NCT01712763     History of Changes
Other Study ID Numbers: C06/2012
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

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