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Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study

Phase 2
18 Years
Not Enrolling
Gonadotroph Adenomas

Thank you

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:


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:


Principal Investigator

Peter J. Snyder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

November 2011

Related Keywords:

  • Gonadotroph Adenomas
  • pituitary tumor
  • endocrine
  • Adenoma



University of PennsylvaniaPhiladelphia, Pennsylvania  19104