NCT01769781

Brief Summary

The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate 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

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

January 15, 2013

Last Update Submit

April 25, 2016

Conditions

Endometriosis

Keywords

endometriosis recurrencepelvic painaromatase inhibitor

Outcome Measures

Primary Outcomes (1)

  • disease free time

    time without pain symptoms due to the disease recurrence

    24 months

Secondary Outcomes (1)

  • time of pain disappearance

    24 months

Other Outcomes (1)

  • reduction of endometriosis lesions

    24 months

Study Arms (2)

anastrazole

EXPERIMENTAL

women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months

Drug: anastrazole

GnRH analog alone

ACTIVE COMPARATOR

women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg

Drug: GnRH analog alone

Interventions

anastrazoleDRUG

combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months

anastrazole
GnRH analog aloneDRUG

treatment for three months with GnRH analog (leuprolide acetate) alone

GnRH analog alone

Eligibility Criteria

Age18 Years - 50 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 (1)

Cerm-Hungaria

Rome, 00153, Italy

Location

MeSH Terms

Conditions

EndometriosisPelvic Pain

Interventions

AnastrozoleGonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • marco sbracia, md

    CERM-HUNGARIA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PRINCIPAL INVESTIGATOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

IT(1)