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

This study has been terminated.
(unable to identify a third subject)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929669
First Posted: June 29, 2009
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: December 12, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gonadotroph Adenomas
Intervention: Drug: pasireotide LAR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was initiated in 6/09 and was terminated in 6/10. 2 subjects were enrolled and 1 subject completed the 12 mos. of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pasireotide LAR 80 mg IM once monthly

Participant Flow:   Overall Study
    Pasireotide LAR
STARTED   2 
COMPLETED   1 
NOT COMPLETED   1 
elevated glucose levels                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pasireotide LAR 80 mg IM once monthly

Baseline Measures
   Pasireotide LAR 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1  50.0% 
>=65 years      1  50.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      2 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   2 
patients with a gonadotroph adenoma 
[Units: Participants]
 2 


  Outcome Measures
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1.  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 ]

2.  Secondary:   Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial was terminated due to difficulty in identifying 3 subjects for completion of the study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Peter J. Snyder, MD
Organization: University of Pennsylvania
phone: 215-898-0208
e-mail: pjs@mail.med.upenn.edu



Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00929669     History of Changes
Other Study ID Numbers: 809652
First Submitted: June 23, 2009
First Posted: June 29, 2009
Results First Submitted: December 12, 2013
Results First Posted: November 28, 2017
Last Update Posted: November 28, 2017