Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

Endometriosis Clinical Trial

— ESIS  

Official title:

Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00761683
• Other study ID #: NIS-ORO-ZOL-2007/1
• Status: Terminated
• Phase: N/A
• First received: September 26, 2008
• Last updated: September 8, 2009
• Start date: October 2008

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biberoglu and Bergham Scale		monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain
Secondary	Biberoglu and Bergham Scale		twice/first and last clinic visit for pelvic tenderness and indurations