Letrozole in the Treatment of Severe and Recurrent Endome... | NCT00240942

Studies
Letrozole in the Treatment of Severe and Recurrent Endometriosis

NCT00240942

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 26, 2012Estimated

Enrollment

Phase

Phase 2

Conditions

Severe and Recurrent Endometriosis

Interventions

Letrozole

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Oct 14, 2005

First Submission Date that Met QC Criteria

Oct 14, 2005

First Posted Date

Oct 18, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2012

Last Update Posted Date

Apr 26, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Letrozole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Duration of clinical response
Time to progression of the disease
Correlation of tumour response with pretreatment ER/PR status

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573