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

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.
ClinicalTrials.gov Identifier: NCT00761683
Recruitment Status : Terminated (Anticipated number of patients not achieved. All Patients recruited in the study completed all study visits.)
First Posted : September 29, 2008
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease
Endometriosis

Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS
Study Start Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Group/Cohort
1
Patients diagnosed with endometriosis



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cristina Pentiuc Medical Manager, AstraZeneca
ClinicalTrials.gov Identifier: NCT00761683     History of Changes
Other Study ID Numbers: NIS-ORO-ZOL-2007/1
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
Endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents