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
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Endometriosis
• Recurrence

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