Effectiveness of SOM230 In Treating Non-Functioning Pituitary Adenomas

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10035079Term: Pituitary adenoma; non-functioning pitiutary adenomes

• Registration Number: EUCTR2005-004413-15-DE
• Lead Sponsor: Cedars Sinai Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or postmenopausal female not receiving HRT; Postmenopausal is defined as a minimum of 12 months absence of menorrhoea.
• Age: 18-80 years
• The patient must have a clinically demonstrable NFT, with no evidence of acromegaly, Cushing’s disease or prolactinoma as demonstrated by normal IGF-1, normal 24-hour urinary free cortisol levels and normal to moderately elevated prolactin levels (stalk effect, prolactin < 200 ng/ml). A screening TRH test must have been performed to confirm possible gonadotroph hypersecretion.
• The patient must have a macroadenoma (>10mm in widest diameter) demonstrated on MRI performed with and without contrast.
• Patients must have a normal visual field evaluation by Goldman perimetry.
• Hypopituitarism may be present as evidenced by any or all of: a subnormal GH response to Arginine/GHRH testing, low age-and sex matched IGF-1 levels, low TSH, free T3 and Free T4, low estradiol, low LH and FSH levels in postmenopausal female patients or low testosterone, LH and FSH levels in male patients, 8 am serum cortisol < 3µg/dl.

Patients who are diagnosed with hypopituitarism, will initiate hormone replacement therapy for the 6 month duration of the study, (except for post-menopausal females) and will be required to discontinue the replacement at the end of 6 months, to re-evaluate hypopituitarism.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients who have had prior surgery, radiotherapy, somatostatin analog or dopamine agonist therapy for their NFT.
• Visual field abnormalities, which will be referred for surgery.
• Evidence of a secretory pituitary tumor as evidenced by elevated IGF-1, increased 24 hr urinary free cortisol level, or prolactin >200 ng/ml.
• It is anticipated that the patient may require pituitary surgery or radiotherapy during the study period.
• Clinically significant renal or hepatic abnormalities.
• Active malignant pathology.
• Evidence of drug/alcohol abuse.
• The patient has received any unlicensed drug within 30 days prior to screening.
• Pregnancy (as indicated by serum ß-HCG pregnancy test, for all female patients with the potential to become pregnant) and patients who are breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified