Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs...
Date First Received: April 13, 2006
Last Updated: May 25, 2006
Verified by: University of Montreal, May 2006
Clinical Trial Phase: Phase 2 | Start Date: May 2006
Overall Status: Recruiting
Estimated Enrollment: 30
Brief Summary
Condition Keyword(s):
Intervention(s):
Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Alesse
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Montreal
Overall Clinical Trial Officials and Contacts
Omar Serri, MD Principal Investigator CHUM- Endocrinology
Overall Contact: Omar SERRI, MD 514-890-8000 omar.serri@umontreal.ca
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00315107
Study ID Number: HND01
ClinicalTrials.gov Identifier: NCT00315107
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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