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Estrogen Treatment in Acromegalic Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by Université de Montréal.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315107
First Posted: April 17, 2006
Last Update Posted: May 26, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by:
Université de Montréal
  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
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00315107     History of Changes
Other Study ID Numbers: HND01
First Submitted: April 13, 2006
First Posted: April 17, 2006
Last Update Posted: May 26, 2006
Last Verified: May 2006

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