Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

NCT ID: NCT00761683

Last Updated: 2009-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients diagnosed with endometriosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Cristina Pentiuc

Role: STUDY_DIRECTOR

AstraZeneca Romania

Locations

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Research Site

Bucharest, , Romania

Site Status

Research Site

Cluj-Napoca, , Romania

Site Status

Research Site

Timișoara, , Romania

Site Status

Countries

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Romania

Other Identifiers

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NIS-ORO-ZOL-2007/1

Identifier Type: -

Identifier Source: org_study_id

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