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Trial record 1 of 1 for:    degarelix | Endometriosis
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Degarelix in the Treatment of Endometriosis Recurrence

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ClinicalTrials.gov Identifier: NCT01712763
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy

Tracking Information
First Submitted Date  ICMJE October 18, 2012
First Posted Date  ICMJE October 24, 2012
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2012)
disease free time [ Time Frame: 24 months ]
time without pain symptoms due to the disease recurrence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2012)
time of disappearance pain [ Time Frame: 24 months ]
time needed during treatment to improve the pain symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 23, 2012)
reduction of endometriosis lesions [ Time Frame: 24 months ]
endometriosis lesions regression during treatment evidenced by MRI scan
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Degarelix in the Treatment of Endometriosis Recurrence
Official Title  ICMJE Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of other systemic diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01712763
Other Study ID Numbers  ICMJE C06/2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre for Endocrinology and Reproductive Medicine, Italy
Study Sponsor  ICMJE Centre for Endocrinology and Reproductive Medicine, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: MARCO SBRACIA, MD Centre for Endocrinology and Reproductive Medicine, Italy
PRS Account Centre for Endocrinology and Reproductive Medicine, Italy
Verification Date April 2016

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