NCT01712763

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 6, 2024

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

October 18, 2012

Last Update Submit

March 4, 2024

Conditions

Endometriosis

Keywords

Endometriosislong acting GnRH antagonistDegarelixRecurrencePelvic Pain

Outcome Measures

Primary Outcomes (1)

  • disease free time

    time without pain symptoms due to the disease recurrence

    24 months

Secondary Outcomes (1)

  • time of disappearance pain

    24 months

Other Outcomes (1)

  • reduction of endometriosis lesions

    24 months

Study Arms (2)

Degarelix

EXPERIMENTAL

180 women will be treated with degarelix 120mg in one administration

Drug: degarelix

leuprolide acetate 11.25 mg/ml

ACTIVE COMPARATOR

180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months

Drug: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)

Interventions

degarelixDRUG

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

Also known as: firmagon
Degarelix
Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)DRUG

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

Also known as: Enantone 11.25
leuprolide acetate 11.25 mg/ml

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • presence of other systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Albania Spitali Amerikan

Tirana, Albania

Location

Nadezda Women's Health Hospital

Sofia, Bulgaria

Location

Cerm-Hungaria

Rome, 00153, Italy

Location

MeSH Terms

Conditions

EndometriosisRecurrencePelvic Pain

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamideLeuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • MARCO SBRACIA, MD

    Centre for Endocrinology and Reproductive Medicine, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 24, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 6, 2024

Record last verified: 2022-02

Locations

BU(1)IT(1)AL(1)