Letrozole in the Treatment of Severe and Recurrent Endometriosis
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: October 14, 2005
Last updated: April 25, 2012
Last verified: April 2012
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.
Severe and Recurrent Endometriosis
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Letrozole in the Treatment of Severe and Recurrent Endometriosis
Primary Outcome Measures:
- 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:
- Duration of clinical response
- Time to progression of the disease
- Correlation of tumour response with pretreatment ER/PR status
- Histological grade and aromatase levels
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Premenopausal women > 18 years of age.
- Laparoscopic and Histologically confirmed diagnosis of moderate or severe endometriosis according rASRM-Score III and IV
- BMI less than 40 kg/m².
- Patient is sexually abstinent or using mechanical (condoms, diaphragms) or sterilization methods of contraception and is willing to continue using them throughout the study.
- Patient is willing and able to comply with study requirements.
- Written informed consent.
- Endometriosis stage I-II acc. according to rASRM
- Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
- Significant abnormalities in the physical or laboratory examination including renal and liver function more than twice the normal range.
- Patient desires pregnancy for the duration of the study, is pregnant or breast feeding.
- GnRH therapy during the last 6 months
- Use of hormonal contraception, selective estrogen receptor modulators, progestins, estrogens, steroids, or ovulation induction in the 4 weeks prior to inclusion into the study.
- Untreated abnormal pap smear or other gynecologic condition.
- History of venous thrombosis events including deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis.
- History of stroke, complicated migraine, or documented transient ischemic attack.
- Known hypersensitivity to any ingredient of the study medication.
- Treatment with other aromatase inhibitors
- Other investigational drugs within the past 30 days and the concomitant use of investigational drugs.
- History of non-compliance to medical regimens, and patients who are considered potentially unreliable.
Additional protocol-defined inclusion / exclusion criteria may apply
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00240942
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 14, 2005
||April 25, 2012
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2014
Genital Diseases, Female
Molecular Mechanisms of Pharmacological Action