Letrozole in the Treatment of Severe and Recurrent Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00240942
First received: October 14, 2005
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Severe and Recurrent Endometriosis
Drug: Letrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Letrozole in the Treatment of Severe and Recurrent Endometriosis

Resource links provided by NLM:


Further study details as provided by Novartis:

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: 40
Study Start Date: October 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240942

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00240942     History of Changes
Other Study ID Numbers: CFEM345ADE04
Study First Received: October 14, 2005
Last Updated: April 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Endometriosis
GnRH analog
Aromataseinhibitor
Letrozole

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014