Degarelix in the Treatment of Endometriosis Recurrence

Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01712763

Enrollment

360

Registered

2012-10-24

Start date

2012-11-30

Completion date

2016-03-31

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Endometriosis, long acting GnRH antagonist, Degarelix, Recurrence, Pelvic Pain

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.

Interventions

DRUGdegarelix

180 women will be treated with degarlix 120 mg, in only one administration covering three months

DRUGLeuprolide Acetate 11.25 MG/ML (Enantone 11,25)

180 women will be treated with leuprolide acetate11.25 only once covering three months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* presence of other systemic diseases

Design outcomes

Primary

Measure	Time frame	Description
disease free time	24 months	time without pain symptoms due to the disease recurrence

Secondary

Measure	Time frame	Description
time of disappearance pain	24 months	time needed during treatment to improve the pain symptoms

Other

Measure	Time frame	Description
reduction of endometriosis lesions	24 months	endometriosis lesions regression during treatment evidenced by MRI scan

Countries

Albania, Bulgaria, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026