Non-Interventional Study of Zoladex in Endometriosis

February 19, 2014 updated by: AstraZeneca

A Non-interventional Study of Postoperative Treatment With Goserelin Acetate (Zoladex) in Moderate to Severe Endometriosis Patient

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Research Site
    • Beijing
      • Beijing, Beijing, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
      • Shenzhen, Guangdong, China
        • Research Site
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Research Site
    • Hunan
      • Changsha, Hunan, China
        • Research Site
    • Liaoning
      • Shenyang, Liaoning, China
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Research Site
    • Shanxi
      • Xi'an, Shanxi, China
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom recurrence rate and total recurrence rate
Time Frame: 18 months
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Zhou Yingfang, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (Estimate)

July 14, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OCN-ZOL-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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