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NCT01712763 Clinical Trial

Degarelix in the Treatment of Endometriosis Recurrence

Endometriosis Clinical Trial

Official title:
Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01712763
Other study ID # C06/2012
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2012
Est. completion date March 2016

Study information
Verified date February 2022
Source Centre for Endocrinology and Reproductive Medicine, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 360
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - women affected by endometriosis showing recurrence of pain symptoms - previous surgery for endometriosis Exclusion Criteria: - presence of other systemic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• degarelix
180 women will be treated with degarlix 120 mg, in only one administration covering three months
• Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)
180 women will be treated with leuprolide acetate11.25 only once covering three months

Locations
Country Name City State
Albania Albania Spitali Amerikan Tirana
Bulgaria Nadezda Women's Health Hospital Sofia
Italy Cerm-Hungaria Rome

Sponsors (1)
Lead Sponsor Collaborator
Centre for Endocrinology and Reproductive Medicine, Italy

Countries where clinical trial is conducted

Albania,  Bulgaria,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Other reduction of endometriosis lesions endometriosis lesions regression during treatment evidenced by MRI scan 24 months
Primary disease free time time without pain symptoms due to the disease recurrence 24 months
Secondary time of disappearance pain time needed during treatment to improve the pain symptoms 24 months
See also
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Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
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Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
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