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
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
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
- 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