NCT00240942

CompletedPhase 2

Letrozole in the Treatment of Severe and Recurrent Endometri...

Novartis Pharmaceuticals Source

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Other study identifiers

Sponsor study identifier

CFEM345ADE04

Study Type

interventional

Reported enrollment (type unavailable)

40

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2006

Actual (reported)

Study Completion

June 2006

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 40 participants
Study completion date: June 2006
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 14, 2005
Actual (reported)
First Posted
October 18, 2005
Actual (reported)
Primary Completion
June 2006
Actual (reported)
Study Completion
June 2006
Actual (reported)

Last Updated: April 26, 2012
Status Verified: April 2012
Last Update Submitted: April 25, 2012

Conditions

Severe and Recurrent Endometriosis

Keywords

EndometriosisGnRH analogAromataseinhibitorLetrozole

Outcome Measures

Primary Outcomes (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 Outcomes (4)

Duration of clinical response
Time to progression of the disease
Correlation of tumour response with pretreatment ER/PR status
Histological grade and aromatase levels

Interventions

LetrozoleDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Premenopausal women \> 18 years of age.
Laparoscopic and Histologically confirmed diagnosis of moderate or severe endometriosis according rASRM-Score III and IV

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

MeSH Terms

Conditions

Endometriosis

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

October 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2006

Actual (reported)

NCT00247663

Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Phase 2Completed

NCT00004251

Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer

Phase 2Completed

NCT00090857

Letrozole in Preventing Breast Cancer in Postmenopausal Women

Phase 2Completed

NCT00291135

Protocol for Women at Increased Risk of Developing Breast Cancer

Phase 2Completed

NCT00505661

Letrozole in Patients With Ovarian Tumors

Phase 2Terminated

NCT04002141

Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis

Phase 2Completed

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.

You may not qualify if:

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
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.

Contact the study team to confirm eligibility.

Heterocyclic Compounds

Study Completion

June 2006

Actual (reported)

Last Updated

April 26, 2012

Record last verified: 2012-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00240942
Data provider: ClinicalTrials.gov
Source updated: 2012-04-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:24 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record