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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study

Conditions
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Gonadotroph Adenomas

Intervention / Treatment
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* Drug: pasireotide LAR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gonadotroph adenoma Exclusion Criteria: visual impairment attributable to the adenoma radiation therapy active gallbladder disease uncontrolled diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pasireotide LAR<br>80 mg IM once monthly | Drug: pasireotide LAR<br>* pasireotide LAR 80 mg IM once a month<br>* Other names: SOM230;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide. | 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%. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pituitary tumor, endocrine