Letrozole in the Treatment of Severe and Recurrent Endometriosis
Phase 2
Completed
- Conditions
- Severe and Recurrent Endometriosis
- Registration Number
- NCT00240942
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Endometriosis is a condition in which abnormal growth of tissue histologically resembling the lining of the uterus (endometrium) is present outside of the uterus. This study will investigate the effect of a daily dose of letrozole compared to GnRH is safe and in addition effective in reducing measurable endometriosis lesions and in reducing pain in patients with active endometriosis which were pretreated with GnRH analogs for 2 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Response rates (CR, PR, NC, PD) during treatment of advanced endometrial cancer assessed by tumor marker assessments and radiologic imaging at week 12 then q 12 weeks x 1 year then q 16 weeks
- Secondary Outcome Measures
Name Time Method Duration of clinical response Time to progression of the disease Correlation of tumour response with pretreatment ER/PR status Histological grade and aromatase levels