Estrogen Treatment in Acromegalic Women

This study is currently recruiting participants.

Verified by University of Montreal, May 2006

Sponsors and Collaborators:	University of Montreal 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

U.S. FDA Resources

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

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

Study placed in the following topic categories:

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

Central Nervous System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009