Letrozole in the Treatment of Severe and Recurrent Endometriosis - Full Text View

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 II

MedlinePlus related topics:

Cancer Endometriosis

ChemIDplus related topics:

Letrozole Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Official Title:	Letrozole in the Treatment of Severe and Recurrent Endometriosis

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

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

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

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Study ID Numbers:	CFEM345ADE04
First Received:	October 14, 2005
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00240942
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Endometriosis

GnRH analog

Aromataseinhibitor

Letrozole

Study placed in the following topic categories:

Genital Diseases, Female

Letrozole

Endometriosis

Recurrence

Additional relevant MeSH terms:

Disease Attributes

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Aromatase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00240942