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
  Purpose

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.


Condition Intervention Phase
Gonadotroph Adenomas
Drug: pasireotide LAR
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • To determine if pasireotide will decrease the size of gonadotroph adenomas as determined by MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if pasireotide will decrease serum FSH concentration in patients who have gonadotroph adenomas. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: June 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide LAR
80 mg IM once monthly
Drug: pasireotide LAR
pasireotide LAR 80 mg IM once a month
Other Name: SOM230

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gonadotroph adenoma

Exclusion Criteria:

  • visual impairment attributable to the adenoma
  • radiation therapy
  • active gallbladder disease
  • uncontrolled diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929669

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Peter J. Snyder, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Peter J. Snyder, MD; Profesor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00929669     History of Changes
Other Study ID Numbers: 809652
Study First Received: June 23, 2009
Last Updated: November 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
pituitary tumor
endocrine

Additional relevant MeSH terms:
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 23, 2014