Letrozole in the Treatment of Severe and Recurrent Endometriosis

Novartis

Status and phase

Completed

Phase 2

Conditions

Severe and Recurrent Endometriosis

Treatments

Drug: Letrozole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00240942

CFEM345ADE04

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.