Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

Short name LAR

NCTNCT00929669Other id809652

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: unable to identify a third subject

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 2 participants (actual)
Sponsor: University of Pennsylvania · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Jun 2009
Primary completion: Nov 2011
Completion: Nov 2011
First posted: 29 Jun 2009 (estimated)
Last update posted: 28 Nov 2017
Conditions: Gonadotroph Adenomas

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2009201020112012

Ph 2
LAR
NCT00929669
Jun 2009 to Nov 2011
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

pasireotide LARDrug

Arms1

Experimental
Pasireotide LAR
80 mg IM once monthly

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
Time frame · 12 months
Registry description
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 outcomes(1)

Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
Time frame · 12 months
Registry description
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%.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 12 months

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

Group	Value (participants)
Pasireotide LAR	0

Secondary and other outcome results(1)

Secondary outcomeNumber· 12 months

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

Group	Value (number of participants)
Pasireotide LAR	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Pasireotide LAR80 mg IM once monthly	–	0 / 2	2 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * gonadotroph adenoma Exclusion Criteria: * visual impairment attributable to the adenoma * radiation therapy * active gallbladder disease * uncontrolled diabetes

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