Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas

This study has been terminated.
(unable to identify a third subject)
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00929669
First received: June 23, 2009
Last updated: November 14, 2011
Last verified: November 2011

June 23, 2009
November 14, 2011
June 2009
November 2011   (final data collection date for primary outcome measure)
To determine if pasireotide will decrease the size of gonadotroph adenomas as determined by MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00929669 on ClinicalTrials.gov Archive Site
To determine if pasireotide will decrease serum FSH concentration in patients who have gonadotroph adenomas. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas
Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study

The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gonadotroph Adenomas
Drug: pasireotide LAR
pasireotide LAR 80 mg IM once a month
Other Name: SOM230
Experimental: Pasireotide LAR
80 mg IM once monthly
Intervention: Drug: pasireotide LAR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • gonadotroph adenoma

Exclusion Criteria:

  • visual impairment attributable to the adenoma
  • radiation therapy
  • active gallbladder disease
  • uncontrolled diabetes
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00929669
809652
Yes
Peter J. Snyder, MD; Profesor of Medicine, University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Peter J. Snyder, MD University of Pennsylvania
University of Pennsylvania
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP