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

Phase 2

Terminated

• Conditions: Gonadotroph Adenomas
• Interventions: Drug: pasireotide LAR

• Registration Number: NCT00929669
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-12-12
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-20
• Last Update Submitted: 2017-10-20
• Results First Posted: 2017-11-28
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• gonadotroph adenoma

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pasireotide LAR	pasireotide LAR	80 mg IM once monthly

Primary Outcome Measures

Name	Time	Method
Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI	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 Outcome Measures

Name	Time	Method
Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.	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%.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States