Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study
18 Years
N/A
Both
Gonadotroph Adenomas
Trial Information
Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study
Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical
treatment as been found that decreases the size of these adenomas, so surgery is the only
treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that
pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas
express these receptors. For this study, three subjects who have gonadotroph adenomas, as
judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be
treated with a long-acting form of pasireotide once a month for one year. The effect of
pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be
judged by the serum concentration.
Inclusion Criteria:
- gonadotroph adenoma
Exclusion Criteria:
- visual impairment attributable to the adenoma
- radiation therapy
- active gallbladder disease
- uncontrolled diabetes
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine if pasireotide will decrease the size of gonadotroph adenomas as determined by MRI
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Peter J. Snyder, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
809652
NCT ID:
NCT00929669
Start Date:
June 2009
Completion Date:
November 2011
Related Keywords:
- Gonadotroph Adenomas
- pituitary tumor
- endocrine
- Adenoma
Name | Location |
|---|---|
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
