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

Gonadotroph Adenomas Clinical Trial

— LAR  

Official title:

Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00929669
• Other study ID #: 809652
• Status: Terminated
• Phase: Phase 2
• First received: June 23, 2009
• Last updated: October 20, 2017
• Start date: June 2009
• Est. completion date: November 2011

Study information

• Verified date: October 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• gonadotroph adenoma

Exclusion Criteria:

• visual impairment attributable to the adenoma

• radiation therapy

• active gallbladder disease

• uncontrolled diabetes

Related Conditions & MeSH terms

• Adenoma
• Gonadotroph Adenomas

Intervention

Drug:
• pasireotide LAR
pasireotide LAR 80 mg IM once a month

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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