Degarelix in the Treatment of Endometriosis Recurrence

• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy (Other)
• Overall Status: Completed
• CT.gov ID: NCT01712763
• Collaborator: (none)
• Enrollment: 360
• Locations: 3
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 120
• Patients Per Site Per Month: 3

Study Details

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
• Actual Enrollment: 360 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: Nov 1, 2012
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Degarelix 180 women will be treated with degarelix 80mg in one administration	Drug: degarelix; 180 women will be treated with degarlix 80 mg, in only one administration covering three months; Other Names: firmagon
Active Comparator: Goserelin 180 women will be treated with goserelin 3.6mg monthly for three months	Drug: goserelin; 180 women will be treated with decapeptyl 3.6 every month for three months; Other Names: decapeptyl

Outcome Measures

Primary Outcome Measures

1. disease free time [24 months]

   time without pain symptoms due to the disease recurrence

Secondary Outcome Measures

1. time of disappearance pain [24 months]

   time needed during treatment to improve the pain symptoms

Other Outcome Measures

1. reduction of endometriosis lesions [24 months]

   endometriosis lesions regression during treatment evidenced by MRI scan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Albania Spitali Amerikan	Tirana		Albania
2	Nadezda Women's Health Hospital	Sofia		Bulgaria
3	Cerm-Hungaria	Rome		Italy	00153

Sponsors and Collaborators

• Centre for Endocrinology and Reproductive Medicine, Italy

Investigators

• Study Chair: MARCO SBRACIA, MD, Centre for Endocrinology and Reproductive Medicine, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy
• ClinicalTrials.gov Identifier: NCT01712763
• Other Study ID Numbers: C06/2012
• First Posted: Oct 24, 2012
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Centre for Endocrinology and Reproductive Medicine, Italy: Endometriosis; long acting GnRH antagonist; Degarelix; Recurrence; Pelvic Pain
• Additional relevant MeSH terms: Endometriosis; Recurrence; Goserelin; Triptorelin Pamoate

Study Results

No Results Posted as of Feb 28, 2022