Non-Interventional Study of Zoladex in Endometriosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00938496

Enrollment

408

Registered

2009-07-14

Start date

2009-07-31

Completion date

2012-02-29

Last updated

2014-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief 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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Symptom recurrence rate and total recurrence rate	18 months

Secondary

Measure	Time frame
Pregnancy rate	18 months
Zoladex administration time	6 months
Add-back therapy information	18 months

Countries

China

Outcome results