Non-Interventional Study of Zoladex in Endometriosis
A Non-interventional Study of Postoperative Treatment With Goserelin Acetate (Zoladex) in Moderate to Severe Endometriosis Patient
1 other identifier
observational
408
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Typical duration for all trials
11 active sites
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
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 9, 2009
CompletedFirst Posted
Study publicly available on registry
July 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 20, 2014
February 1, 2014
2.6 years
July 9, 2009
February 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Symptom recurrence rate and total recurrence rate
18 months
Secondary Outcomes (3)
Pregnancy rate
18 months
Zoladex administration time
6 months
Add-back therapy information
18 months
Eligibility Criteria
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
You may qualify if:
- Advanced endometriosis confirmed histologically (r-AFS score III-IV) with conservative laparoscopy or laparotomy.
- Patient has been already prescribed Zoladex within 1 month after operation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (11)
Research Site
Hefei, Anhui, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Shenzhen, Guangdong, China
Research Site
Harbin, Heilongjiang, China
Research Site
Changsha, Hunan, China
Research Site
Shenyang, Liaoning, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Xi’an, Shanxi, China
Research Site
Chengdu, Sichuan, China
Research Site
Hangzhou, Zhejiang, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhou Yingfang
Peking University First Hospital
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2009
First Posted
July 14, 2009
Study Start
July 1, 2009
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 20, 2014
Record last verified: 2014-02