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Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas

Phase 4
18 Years
80 Years
Not Enrolling

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Trial Information

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

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.

Inclusion Criteria:

- GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.

- Pituitary tumor by MRI-scan.

Exclusion Criteria:

- Immediate surgery indicated by usual clinical criteria.

- Pregnant.

- Known adverse effects of octreotide.

- Unfit for participation by any other reason.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Surgical cure by transsphenoidal surgery

Outcome Time Frame:

Primarily 3 months postoperatively, but up to 10 years postoperatively

Safety Issue:


Principal Investigator

Sven M Carlsen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Endocrinology, St. Olavs Hospital, University Hospital of Trondheim, Trondheim, Norway


Norway:National Committee for Medical and Health Research Ethics

Study ID:

S-71-98 (REK)



Start Date:

September 1999

Completion Date:

May 2010

Related Keywords:

  • Acromegaly
  • Acromegaly
  • Acromegaly
  • Growth Hormone-Secreting Pituitary Adenoma