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Letrozole in the Treatment of Severe and Recurrent Endometriosis

Phase 2
18 Years
Not Enrolling
Severe and Recurrent Endometriosis

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Trial Information

Letrozole in the Treatment of Severe and Recurrent Endometriosis

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2002

Completion Date:

June 2006

Related Keywords:

  • Severe and Recurrent Endometriosis
  • Endometriosis
  • GnRH analog
  • Aromataseinhibitor
  • Letrozole
  • Endometriosis