Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS (ESIS)

This study has been terminated.
(Anticipated number of patients not achieved. All Patients recruited in the study completed all study visits.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00761683
First received: September 26, 2008
Last updated: September 8, 2009
Last verified: September 2009
  Purpose

To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with Zoladex 3.6 mg.


Condition
Endometriosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Biberoglu and Bergham Scale [ Time Frame: monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain ]

Secondary Outcome Measures:
  • Biberoglu and Bergham Scale [ Time Frame: twice/first and last clinic visit for pelvic tenderness and indurations ]

Estimated Enrollment: 105
Study Start Date: October 2008
Groups/Cohorts
1
Patients diagnosed with endometriosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The programme will include the patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program.

Criteria

Inclusion Criteria:

  • patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program, according to Romanian approved goserelin 3,6 mg

Exclusion Criteria:

  • patients who have a known hypersensitivity to goserelin (Zoladex) or any of its excipients or any other GnRH analogue, pregnancy, according to Romanian approved goserelin 3,6 mg SmPC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761683

Locations
Romania
Research Site
Bucuresti, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Timisoara, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Cristina Pentiuc AstraZeneca Romania
  More Information

No publications provided

Responsible Party: Cristina Pentiuc Medical Manager, AstraZeneca
ClinicalTrials.gov Identifier: NCT00761683     History of Changes
Other Study ID Numbers: NIS-ORO-ZOL-2007/1
Study First Received: September 26, 2008
Last Updated: September 8, 2009
Health Authority: Romania: National Medicines Agency

Keywords provided by AstraZeneca:
Endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014