Sandostatin LAR Depot vs. Surgery for Treating Acromegaly
Status:
Completed
Trial end date:
2002-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered
Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with
macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels.
Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and
transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to
less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly,
reduce the size of the macroadenomas, produce few side effects, assess the prognostic value
of baseline pituitary adenoma size, extension and baseline growth hormone level on
post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each
treatment type.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)