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Letrozole in the Treatment of Severe and Recurrent Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00240942
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : April 26, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 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 or disease Intervention/treatment Phase
Severe and Recurrent Endometriosis Drug: Letrozole Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Letrozole in the Treatment of Severe and Recurrent Endometriosis
Study Start Date : October 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Letrozole

Primary Outcome Measures :
  1. 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 :
  1. Duration of clinical response
  2. Time to progression of the disease
  3. Correlation of tumour response with pretreatment ER/PR status
  4. Histological grade and aromatase levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240942

Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00240942    
Other Study ID Numbers: CFEM345ADE04
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
GnRH analog
Additional relevant MeSH terms:
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Genital Diseases, Female
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs