Estrogen Treatment in Acromegalic Women

This study is currently recruiting participants.

Verified by University of Montreal, May 2006

First Received: April 13, 2006 Last Updated: May 25, 2006 History of Changes

Sponsor:	University of Montreal
Collaborator:	Novartis
Information provided by:	University of Montreal
ClinicalTrials.gov Identifier:	NCT00315107

Purpose

Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.

Condition	Intervention	Phase
Acromegaly	Drug: Alesse	Phase II

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by University of Montreal:

Estimated Enrollment:	30
Study Start Date:	May 2006
Estimated Study Completion Date:	August 2007

Detailed Description:

This will be a canadian multicenter study with a randomized, double-blind, placebo-controlled design, to assess the efficacy and safety of adjuvant alesse in female acromegalic patients with suboptimal response to sandostatin LAR treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women 18 years and older treated with somatostatin analogs
Active acromegaly

Exclusion Criteria:

Cardiovascular or cerebrovascular disease
Thrombophlebitis or thromboembolism
Breast cancer
Non-controlled arterial hypertension
Smoking
Pregnancy or lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315107

Contacts

Contact: Omar SERRI, MD

514-890-8000 ext 25607

omar.serri@umontreal.ca

Locations

Canada, Quebec
CHUM - Notre-Dame Hospital	Recruiting
Montreal, Quebec, Canada, H2L 4M1
Principal Investigator: Omar Serri, MD

Sponsors and Collaborators

University of Montreal

Novartis

Investigators

Principal Investigator:

Omar Serri, MD

CHUM- Endocrinology

More Information

No publications provided

Study ID Numbers:	HND01
Study First Received:	April 13, 2006
Last Updated:	May 25, 2006
ClinicalTrials.gov Identifier:	NCT00315107 History of Changes
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Pituitary Diseases
Bone Diseases, Endocrine
Hypothalamic Diseases
Hyperpituitarism
Musculoskeletal Diseases
Nervous System Diseases

Endocrine System Diseases
Central Nervous System Diseases
Brain Diseases
Bone Diseases
Acromegaly

ClinicalTrials.gov processed this record on February 08, 2010