Non-Interventional Study of Zoladex in Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938496
• Other study ID #: NIS-OCN-ZOL-2009/1
• Status: Completed
• Phase: N/A
• First received: July 9, 2009
• Last updated: February 19, 2014
• Start date: July 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom recurrence rate and total recurrence rate		18 months	No
Secondary	Pregnancy rate		18 months	No
Secondary	Zoladex administration time		6 months	No
Secondary	Add-back therapy information		18 months	No

External Links

•   CSR-NIS-OCN-ZOL-2009-1.pdf