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 19, 2014
Last verified: February 2014

July 9, 2009
February 19, 2014
July 2009
February 2012   (final data collection date for primary outcome measure)
Symptom recurrence rate and total recurrence rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00938496 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00938496
NIS-OCN-ZOL-2009/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Zhou Yingfang Peking University First Hospital
AstraZeneca
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP