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Estrogen Treatment in Acromegalic Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Université de Montréal.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT00315107
First received: April 13, 2006
Last updated: May 25, 2006
Last verified: May 2006
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind

Further study details as provided by Université de Montréal:

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
Université de Montréal
Novartis
Investigators
Principal Investigator: Omar Serri, MD CHUM- Endocrinology
  More Information

No publications provided

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

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013