Anastrazole Plus GnRH-agonist in the Treatment of Endomet... | NCT01769781

Studies
Anastrazole Plus GnRH-agonist in the Treatment of Endometriosis Recurrence

NCT01769781

Sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Status

Completed

Last Update Posted

Apr 27, 2016Estimated

Enrollment

70Actual

Phase

Phase 4

Conditions

Endometriosis

Interventions

anastrazole
GnRH analog alone

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jan 15, 2013

First Submission Date that Met QC Criteria

Jan 16, 2013

First Posted Date

Jan 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2016

Last Update Posted Date

Apr 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fabio Scarpellini, PRINCIPAL INVESTIGATOR, Centre for Endocrinology and Reproductive Medicine, ItalyPrincipal Investigator

Lead Sponsor

Centre for Endocrinology and Reproductive Medicine, ItalyNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
anastrazole	Drug	combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months	anastrazole

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

presence of other systemic diseases

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
marco sbracia, md	CERM-HUNGARIA	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Cerm-Hungaria		Rome		00153	Italy

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077384	Anastrozole
D007987	Gonadotropin-Releasing Hormone

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided