Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
After a baseline evaluation, patients are randomized separately for each study center in
blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with
octreotide.
To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide
is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three
times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR
(Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months.
Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are
delayed, an extra octreotide LAR injection is given before surgery.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Surgical cure by transsphenoidal surgery
Primarily 3 months postoperatively, but up to 10 years postoperatively
No
Sven M Carlsen, MD, PhD
Principal Investigator
Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway
Norway:National Committee for Medical and Health Research Ethics
S-71-98 (REK)
NCT00521300
September 1999
May 2010
Name | Location |
---|