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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929669
Recruitment Status : Terminated (unable to identify a third subject)
First Posted : June 29, 2009
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Information provided by (Responsible Party):
University of Pennsylvania

June 23, 2009
June 29, 2009
December 12, 2013
November 28, 2017
November 28, 2017
June 2009
November 2011   (Final data collection date for primary outcome measure)
Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI [ Time Frame: 12 months ]
MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.
To determine if pasireotide will decrease the size of gonadotroph adenomas as determined by MRI [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00929669 on Archive Site
Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide. [ Time Frame: 12 months ]
Serum FSH (mIU/mL) will be measured at baseline and then monthly for the 12 months of the study to determine if serum FSH concentrations decrease by 20%.
To determine if pasireotide will decrease serum FSH concentration in patients who have gonadotroph adenomas. [ Time Frame: 12 months ]
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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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: Undecided
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Peter J. Snyder, MD University of Pennsylvania
University of Pennsylvania
October 2017

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