Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

Terminated

• Conditions: Endometriosis

• Registration Number: NCT00761683
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Study Start: 2008-10
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-08
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 105

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biberoglu and Bergham Scale	monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain

Secondary Outcome Measures

Name	Time	Method
Biberoglu and Bergham Scale	twice/first and last clinic visit for pelvic tenderness and indurations

Trial Locations

Locations (1)

Research Site; 🇷🇴 Timisoara, Romania