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Degarelix in the Treatment of Endometriosis Recurrence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712763
First Posted: October 24, 2012
Last Update Posted: April 27, 2016
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.
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy
October 18, 2012
October 24, 2012
April 27, 2016
November 2012
March 2016   (Final data collection date for primary outcome measure)
disease free time [ Time Frame: 24 months ]
time without pain symptoms due to the disease recurrence
Same as current
Complete list of historical versions of study NCT01712763 on ClinicalTrials.gov Archive Site
time of disappearance pain [ Time Frame: 24 months ]
time needed during treatment to improve the pain symptoms
Same as current
reduction of endometriosis lesions [ Time Frame: 24 months ]
endometriosis lesions regression during treatment evidenced by MRI scan
Same as current
 
Degarelix in the Treatment of Endometriosis Recurrence
Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Endometriosis
  • Drug: degarelix
    50 women will be treated with degarlix 80 mg, in only one administration covering three months
    Other Name: firmagon
  • Drug: goserelin
    50 women will be treated with decapeptyl 3.6 every month for three months
    Other Name: decapeptyl
  • Experimental: Degarelix
    50 women will be treated with degarelix 80mg in one administration
    Intervention: Drug: degarelix
  • Active Comparator: Goserelin
    goserelin 3.6mg monthly for three months
    Intervention: Drug: goserelin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • women affected by endometriosis showing recurrence of pain symptoms
  • previous surgery for endometriosis

Exclusion Criteria:

  • presence of other systemic diseases
Sexes Eligible for Study: Female
20 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01712763
C06/2012
Yes
Not Provided
Not Provided
Centre for Endocrinology and Reproductive Medicine, Italy
Centre for Endocrinology and Reproductive Medicine, Italy
Not Provided
Study Chair: MARCO SBRACIA, MD Centre for Endocrinology and Reproductive Medicine, Italy
Centre for Endocrinology and Reproductive Medicine, Italy
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP