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Non-Interventional Study of Zoladex in Endometriosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938496
First Posted: July 14, 2009
Last Update Posted: February 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
July 9, 2009
July 14, 2009
February 20, 2014
July 2009
February 2012   (Final data collection date for primary outcome measure)
Symptom recurrence rate and total recurrence rate [ Time Frame: 18 months ]
Same as current
Complete list of historical versions of study NCT00938496 on ClinicalTrials.gov Archive Site
  • Pregnancy rate [ Time Frame: 18 months ]
  • Zoladex administration time [ Time Frame: 6 months ]
  • Add-back therapy information [ Time Frame: 18 months ]
Same as current
Not Provided
Not Provided
 
Non-Interventional Study of Zoladex in Endometriosis
A Non-interventional Study of Postoperative Treatment With Goserelin Acetate (Zoladex) in Moderate to Severe Endometriosis Patient
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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
Endometriosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
408
February 2012
February 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00938496
NIS-OCN-ZOL-2009/1
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Zhou Yingfang Peking University First Hospital
AstraZeneca
February 2014