Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00761683

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

MedlinePlus related topics: Endometriosis

Drug Information available for: Goserelin

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	105
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2009

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

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

Contacts

Contact: AstraZeneca Romania Medical Department Clinical Study Information

+4021 317 60 41

denissa.turneanu@astrazeneca.com

Locations

Romania
Research Site	Recruiting
Cluj-Napoca, Romania
Research Site	Recruiting
Bucuresti, Romania
Research Site	Not yet recruiting
Timisoara, Romania

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Cristina Pentiuc

AstraZeneca Romania

More Information

Responsible Party:	AstraZeneca ( Cristina Pentiuc Medical Manager )
Study ID Numbers:	NIS-ORO-ZOL-2007/1
Study First Received:	September 26, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00761683
Health Authority:	Romania: National Medicines Agency

Keywords provided by AstraZeneca:

Endometriosis

Study placed in the following topic categories:

Genital Diseases, Female
Goserelin
Endometriosis

ClinicalTrials.gov processed this record on January 14, 2009