DRUG
pasireotide LAR
pasireotide LAR 80 mg IM once a month
Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas
Status
Terminated
Phase
Phase 2
Enrollment
2
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 29, 2009
Study start
Jun 2009
Primary completion
Nov 2011
Study completion
Nov 2011
Results posted
Nov 28, 2017
Registry updated
Nov 28, 2017
Outcomes
What the study measures.
Primary outcomes
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.
Secondary outcomes
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%.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * gonadotroph adenoma Exclusion Criteria: * visual impairment attributable to the adenoma * radiation therapy * active gallbladder disease * uncontrolled diabetes
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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