Inclusion Criteria
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