Monocenter, double blinded, exploratory, randomized, study investigating the influence of Pasireotide on the hormonal activity of Prolactinomas - proof of concept study

Registry ID

EUCTR2006-007036-95

Source registry

EUCTR

Status

Prematurely Ended

Phase

PHASE2

Sponsor

Universitätsklinikum Essen - Zentrum für Innere Medizin - Klinik für Endokrinologie

Start date

2008-05-26

Completion date

2009-12-17

Last update

2026-08-16

Conditions

• Prolactinoma

Summary

The primary study objective is to evaluate the rate of patients responding to a dose of 600 and 900 µg Pasireotide (SOM230), given in a randomized order within two consecutive days, that is within 48 h. Response is defined as a minimal 25% decrease of the primarily elevated Prolactin values. A cross-over study design was chosen to discriminate between the potential effects of different doses of Pasireotide (600 µg, 900 µg, or the sum of both) on serum Prolactin levels.

Locations

• , , Germany

Related clinical trials

• An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
• Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
• How Estrogen Fluctuations Before Diagnosis Affect the Size Prolactin-secreting Tumors
• Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment

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