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

NCT ID: NCT00929669

Last Updated: 2017-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-11-30

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.

Conditions

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Gonadotroph Adenomas

Keywords

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pituitary tumor endocrine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pasireotide LAR

80 mg IM once monthly

Group Type EXPERIMENTAL

pasireotide LAR

Intervention Type DRUG

pasireotide LAR 80 mg IM once a month

Interventions

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pasireotide LAR

pasireotide LAR 80 mg IM once a month

Intervention Type DRUG

Other Intervention Names

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SOM230

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter J. Snyder, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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809652

Identifier Type: -

Identifier Source: org_study_id