Text Size

Non-Interventional Study of Zoladex in Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00938496
First received: July 9, 2009
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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: Time Perspective: 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
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 ]

Enrollment: 426
Study Start Date: May 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
  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

Locations
China, Anhui
Research Site
Hefei, Anhui, China
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
Research Site
Shenzhen, Guangdong, China
China, Heilongjiang
Research Site
Harbin, Heilongjiang, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Zhou Yingfang Peking University First Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00938496     History of Changes
Other Study ID Numbers: NIS-OCN-ZOL-2009/1
Study First Received: July 9, 2009
Last Updated: February 22, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013