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Letrozole in the Treatment of Severe and Recurrent Endometriosis

Primary Purpose

Severe and Recurrent Endometriosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Letrozole
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe and Recurrent Endometriosis focused on measuring Endometriosis, GnRH analog, Aromataseinhibitor, Letrozole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    October 14, 2005
    Last Updated
    April 25, 2012
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00240942
    Brief Title
    Letrozole in the Treatment of Severe and Recurrent Endometriosis
    Official Title
    Letrozole in the Treatment of Severe and Recurrent Endometriosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe and Recurrent Endometriosis
    Keywords
    Endometriosis, GnRH analog, Aromataseinhibitor, Letrozole

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Letrozole
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Duration of clinical response
    Title
    Time to progression of the disease
    Title
    Correlation of tumour response with pretreatment ER/PR status
    Title
    Histological grade and aromatase levels

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Letrozole in the Treatment of Severe and Recurrent Endometriosis

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