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): 18.0-70.0,  Cushing's Disease Corticotrophin Adenoma Male or female patients aged 18 years or greater Patients with confirmed diagnosis of ACTH-dependent Cushing's disease as evidenced by Mean urinary free cortisol of four 24-hour urine samples collected within 2 weeks, at least 1.5 times the upper limit of the laboratory normal range Morning plasma ACTH within the normal or above normal range Either MRI confirmation of pituitary macroadenoma (greater than or equal to 1 cm), or inferior petrosal sinus gradient >3 after CRH stimulation for those patients with a microadenoma (tumor less than 1 cm)*, or for patients who have had prior pituitary surgery, histopathology confirming an ACTH staining adenoma if IPSS had previously been performed without CRH (e.g.with DDAVP), then a central to peripheral pre-stimulation gradient > 2 is required. If IPSS had not previously been performed, IPSS with CRH stimulation is required Patients with de novo Cushing's disease can be included only if they are not considered candidates for pituitary surgery (e.g. poor surgical candidates, surgically unapproachable tumors, patients who refuse to have surgical treatment) Confirmatory testing prior to IPSS (low-dose dexamethasone suppression testing or dexamethasone-CRH testing) has to be performed for patients with UFC ≤ 3.0 X ULN and a pituitary microadenoma in order to possible pseudo-Cushing's syndrome Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of this personal needs) For patients on medical treatment for Cushing's disease the following washout periods must be completed before baseline efficacy assessments are performed  Patients who have received pituitary irradiation within the last ten years prior to visit 1, as the onset time of the radiation effects cannot be determined Patients who have treated with mitotane during the last 6 months prior to Visit 1 Patients with compression of the optic chiasm causing any visual field defect, in order to patients with a tumor causing chiasma compression requiring surgery Patients with Cushing's syndrome due to ectopic ACTH secretion Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1) Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA) Patients who are hypothyroid and not on adequate replacement therapy Patients who have undergone major surgery within 1 month prior to starting the study Patients with symptomatic cholelithiasis