Non-Interventional Study of Zoladex in Endometriosis

This study is currently recruiting participants.

Verified by AstraZeneca, July 2009

First Received: July 9, 2009 Last Updated: July 19, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00938496

Purpose

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.

Condition
Endometriosis

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Non-interventional Study of Postoperative Treatment With Goserelin Acetate (Zoladex) in Moderate to Severe Endometriosis Patient

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis

Drug Information available for: Goserelin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Symptom recurrence rate and total recurrence rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pregnancy rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Zoladex administration time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Add-back therapy information [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2011

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938496

Contacts

Contact: AstraZeneca China Clinical Study Information

800-820-8116

tracy.shi@AstraZeneca.com

Locations

China
Research Site	Not yet recruiting
Beijing, China
Research Site	Not yet recruiting
Shanghai, China
China, Guangdong
Research Site	Not yet recruiting
Guangzhou, Guangdong, China
Research Site	Recruiting
Shenzhen, Guangdong, China
China, Heilongjiang
Research Site	Not yet recruiting
Harbin, Heilongjiang, China
China, Hubei
Research Site	Not yet recruiting
Wuhan, Hubei, China
China, Hunan
Research Site	Not yet recruiting
Changsha, Hunan, China
China, Jiangsu
Research Site	Not yet recruiting
Nanjing, Jiangsu, China
China, Liaoning
Research Site	Not yet recruiting
Shenyang, Liaoning, China
China, Shandong
Research Site	Not yet recruiting
Jinan, Shandong, China
China, Sichuan
Research Site	Not yet recruiting
Chengdu, Sichuan, China
China, Zhejiang
Research Site	Not yet recruiting
hangzhou, Zhejiang, China

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Zhou Yingfang

Peking University First Hospital

More Information

No publications provided

Responsible Party:	AstraZeneca ( MC MD )
Study ID Numbers:	NIS-OCN-ZOL-2009/1
Study First Received:	July 9, 2009
Last Updated:	July 19, 2009
ClinicalTrials.gov Identifier:	NCT00938496 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female
Goserelin
Endometriosis

Additional relevant MeSH terms:

Genital Diseases, Female
Endometriosis

ClinicalTrials.gov processed this record on September 11, 2009