Status:
COMPLETED
Letrozole in the Treatment of Severe and Recurrent Endometriosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Severe and Recurrent Endometriosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 effec...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00240942
Start Date
October 1 2002
End Date
June 1 2006
Last Update
April 26 2012
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