Non-Interventional Study of Zoladex in Endometriosis

Completed

• Conditions: Endometriosis

• Registration Number: NCT00938496
• Lead Sponsor: AstraZeneca

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 available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 408

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom recurrence rate and total recurrence rate	18 months

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	18 months
Zoladex administration time	6 months
Add-back therapy information	18 months

Trial Locations

Locations (1)

Research Site; 🇨🇳 Hangzhou, Zhejiang, China