Patient description: A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.

Clinical trial eligibility criteria: eligible ages (years): 0.0-999.0,  Acromegaly Pituitary Neoplasm Male or female patients, 18 years of age or older. Newly diagnosed patients with acromegaly, or previously untreated. Presence of a pituitary tumor greater than 10 mm at greatest diameter (macroadenoma). Lack of suppression of GH to less than 2.0 ng/mL using a regular GH RIA, or less than one ng/mL using a two-site immunoradiometric or chemiluminescent GH assay, after oral administration of 100 g of glucose. IGF-1 levels above the upper limits of normal (adjusted for age and gender). Demonstrated tolerance to a test dose of s.c. Sandostatin Injection. Demonstrated responsiveness to a 100 ug s.c. Sandostatin Injection test dose, as evidenced by suppression of mean 4HR GH to less than 5 ng/mL, or to greater than 50 % of the baseline value. Patients who are able to provide written informed consent  Patients demonstrating intolerance to a s.c. Sandostatin (octreotide acetate) test dose. Patients who have received any prior treatment for their acromegaly, including radiotherapy, octreotide, bromocriptine, lanreotide, or prior surgery. Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Patients with compression of the optic chiasm significant enough to cause visual field defects on automated testing. Patients who require surgery for relief of any neurologic signs or symptoms associated with their tumor. Patients with symptomatic cholelithiasis. Patients who have congestive heart failure (NYHA Class III and IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction within the three months preceding study entry. Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, or alkaline phosphatase 2X greater than upper limit of normal; or direct bilirubin more than 10% greater than upper limit of normal. Patients with abnormal clinical laboratory values considered by the Investigator or the Sponsor's Medical Monitor to be clinically significant and which could affect the interpretation of the study results. Patients who have any current or prior medical condition that may interfere with the conduct of the study or of the evaluation of its result in the opinion of the Investigator or Sponsor's Medical Monitor. Patients who have a history of alcohol or drug abuse in the six month period prior to Visit 1. Patients who have received any investigational drug within one month prior to Visit 1, or who plan to take an investigational drug during the study. Patients with any mental impairment limiting their ability to comply with all study requirements. Patients who, for any reason, will be unable to complete the entire study