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OpenTrials
Completed

NCT Number: NCT00938496

Non-Interventional Study of Zoladex in Endometriosis

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Symptom recurrence rate and total recurrence rate

    Time frame: 18 months

Secondary outcomes

  1. Pregnancy rate

    Time frame: 18 months

  2. Zoladex administration time

    Time frame: 6 months

  3. Add-back therapy information

    Time frame: 18 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 14, 2009
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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