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

University of Pennsylvania

Status and phase: Terminated; Phase 2

Conditions: Gonadotroph Adenomas

Treatments: Drug: pasireotide LAR

Study type: Interventional

Funder types: Other

Identifiers

NCT00929669

809652

Details and patient eligibility

About

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 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gonadotroph adenoma

Exclusion criteria

• visual impairment attributable to the adenoma
• radiation therapy
• active gallbladder disease
• uncontrolled diabetes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Pasireotide LAR

Experimental group

Description:

80 mg IM once monthly

Treatment:

Drug: pasireotide LAR