- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00315107
Estrogen Treatment in Acromegalic Women
May 25, 2006 updated by: Université de Montréal
Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.
Study Overview
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.
Study Type
Interventional
Enrollment
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Omar SERRI, MD
- Phone Number: 25607 514-890-8000
- Email: omar.serri@umontreal.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2L 4M1
- Recruiting
- CHUM - Notre-Dame Hospital
-
Principal Investigator:
- Omar Serri, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Omar Serri, MD, CHUM- Endocrinology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion
August 1, 2007
Study Registration Dates
First Submitted
April 13, 2006
First Submitted That Met QC Criteria
April 13, 2006
First Posted (Estimate)
April 17, 2006
Study Record Updates
Last Update Posted (Estimate)
May 26, 2006
Last Update Submitted That Met QC Criteria
May 25, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HND01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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