Non-Interventional Study of Zoladex in Endometriosis | NCT00938496

Studies
Non-Interventional Study of Zoladex in Endometriosis

NCT00938496

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Feb 20, 2014Estimated

Enrollment

408Actual

Phase

Not provided

Conditions

Endometriosis

Interventions

Not provided

Countries

China

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

Feb 2014

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

Jul 2009

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jul 9, 2009

First Submission Date that Met QC Criteria

Jul 13, 2009

First Posted Date

Jul 14, 2009Estimated

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

Feb 19, 2014

Last Update Posted Date

Feb 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is a prospective, open label NIS, which is to assess the efficacy of Zoladex in adjuvant setting after operation in moderate to severe endometriosis patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

408Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom recurrence rate and total recurrence rate		18 months

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy rate		18 months
Zoladex administration time		6 months
Add-back therapy information

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced endometriosis confirmed histologically (r-AFS score III-IV) with conservative laparoscopy or laparotomy.
Patient who has the indication of Zoladex and has been prescribed Zoladex according to physician's judgement, irrespective of the inclusion in the study.
Patient has been already prescribed Zoladex within 1 month after operation.

Exclusion Criteria:

Have used hormone treatment prior to 3 months of recruitment.
Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
Previous enrolment in the present study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study Population Description: Patient with advanced endometriosis confirmed histological (r-AFS score III-IV) with conservative laparoscopy or laparotomy has the indication of Zoladex and has already been prescribed Zoladex according to physician's judgment, irrespective of the inclusion in the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhou Yingfang	Peking University First Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Hefei	Anhui		China
Research Site

Label	URL
CSR-NIS-OCN-ZOL-2009-1.pdf	View source

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

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