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STUDY NOW CLOSED
Research Study
SOM230: A Phase III Study to
Assess the Safety and Efficacy of SOM230 in Patients with
Cushing's Disease

This Phase III clinical research study is designed to investigate the effects of an investigational medication (not approved by the Food and Drug Administration), SOM230, in patients with active Cushing's disease. Primary treatment for Cushing's disease is surgery to remove the tumor causing elevated ACTH and cortisol levels. SOM230 may provide an alternative medical treatment for patients with Cushing's disease. Eligible adult subjects include ones that have confirmed diagnosis of Cushing's disease, have not undergone radiation therapy for their Cushing's within the last 2 years and and/or have not been cured with surgery. There are 11 visits over six months of study participation. Patients will receive SOM230 and study related procedures at no charge. Those patients who receive benefit from this medication will be offered enrollment in an open-label/extension study, where SOM230 will be offered at no charge until it is approved by the U.S. Food and Drug Administration. Additional information on this study is available at www.novartisclinicaltrials.com (keyword: cushing) and www.cushingsresearch.com.
 

The above study is being conducted at multiple centers. To find the center closest to you, you can check:
www.clinicaltrials.gov
or send an email through the Norvartis site at: http://www.novartisclinicaltrials.com
 

WOMEN WITH PITUITARY PROBLEMS WANTED FOR A
TESTOSTERONE STUDY

Purpose: Testosterone is the principal male sex hormone but is also present in smaller amounts and may be important in women. Among its likely actions in women are the building of bone and muscle mass, increase in interest in sex (libido) and effects on the mood. The role of testosterone replacement in women with low testosterone levels is currently being studied. In this study, you will be given an experimental preparation of a testosterone gel or placebo gel which will be applied on the skin of your outer thigh for 6 months. It is anticipated that this experimental gel application will produce levels of the drug in the normal range for women. You will get the testosterone gel for one year after the study, regardless of whether you were on testosterone gel or placebo gel during the study. You will also receive growth hormone without charge if it is determined that you are growth hormone deficient.
 

The aim of this study is to assess whether testosterone gel will improve body composition, muscle strength, thinking and sexual function in female patients with dysfunction of the pituitary gland. We will also carefully record side effects related to testosterone. It is expected that this study will determine if testosterone replacement is beneficial in women with pituitary dysfunction.

Criteria for subjects:

• Women ages 18 to 55.
• Hypopituitarism with documented central adrenal or gonadal deficiencies
• Serum testosterone level of < 20 ng/dl or free testosterone <1.5 pg/ml (can be tested at study site)
• Written informed consent
• No other significant medical condition
• Patients must discontinue their current testosterone or DHEA replacement

Number of patients-80

Location: King/Drew Medical Center in Willowbrook and UCLA in West Los Angeles

Enrollment Period: 2004 and ongoing

Patient Compensation: $800

For more information or subject referrals contact:

Ted Friedman, M.D., Ph.D. Clinical Director
Erik Zuckerbraun, M.D. Clinical Coordinator
Telephone (323) 563-9385
Email: study@goodhormonehealth.com
Fax: (323) 563-9324
Charles R. Drew University of Medicine and Sciences
1731 E. 120th St. Los Angeles, California 90059

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Research Study - Mifepristone Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion

Purpose: Cushing's syndrome is caused sometimes by ectopic ACTH secretion. If an ectopic tumor cannot be found or if surgery cannot be done, medicines that reduce cortisol production can be given.
Mifepristone is a drug that blocks the action of cortisol in the body. High daily doses of mifepristone have been used safely to treat a few subjects with Cushing's syndrome as well as certain kinds of cancer, gynecological diseases, and psychiatric disorders. No major safety issues have been raised from these clinical studies. In addition, mifepristone has been used safely in many countries for more than ten years at a single dose of 600 mg to terminate early pregnancy.

You will take mifepristone by mouth three times a day. The dose of mifepristone will be increased every week until you reach the highest dosage allowed, or your symptoms are clearly improving. You will stay in the hospital during this period. Thereafter, you will return to the hospital every three months for the assessment of your condition. You will be able to take mifepristone for up to 12 months if you continue to do well. During the study period you will undergo physical examination, electrocardiogram and a scan to measure body composition intermittently, and you will fill out several standard questionnaires. Blood will be drawn periodically to measure hormone levels and to monitor the safety of mifepristone. If you are a woman, ultrasound examinations of the uterine lining will be performed.

The aim of this study is assess whether mifepristone will improve high blood pressure, diabetes or other symptoms of Cushing's syndrome in subjects with ectopic ACTH secretion.

Criteria for admission into the study:

• Age 18 to 75 years
• Cushing's syndrome caused by ACTH ectopic secretion confirmed biochemically
• Glucose intolerance or diabetes and/or hypertension that is considered to be caused or worsened by the hypercortisolism
   
• Women should be sterilized, post-menopausal, sexually inactive or willing to use barrier methods of contraception throughout the study.
• Subject willing to return to NIH during the full course of the study
• No recent changes in corrective treatments for diabetes, hypertension or depression
• No severe cardiovascular, liver or renal impairment
• Patients must discontinue all approved or experimental steroidogenesis inhibitors, adrenolytic agents or somatostatin analogues within four weeks of admission
• Body weight less than 136 kg

Number of patients - 35

Location: National Institutes of Health, Bethesda, Maryland

Enrollment Period: 2007 and ongoing

For more information or subject referrals contact:

Marina Zemskova, M.D.
Telephone (301) 594-3385
Email: marinaz@mail.nih.gov
Fax: 301-402-0884
NIH/NIDDK-NICHD
10 Center Drive,
Room 6-3940
Bethesda, MD 20892

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Criteria for subjects:

• Male or females; female patients must be either postmenopausal, and not receiving hormone replacement therapy or of childbearing potential, and practicing a medically acceptable method of birth control.
• Age: 18-65 years
• Clinically demonstrable ACTH-secreting tumor, evidence of biochemically active disease, this includes elevated 24 hour urinary free cortisol levels on at least 2 separate 24 hour urine collections a week apart.
• Lack of suppression of 0800h serum cortisol to <1.8 µg /dl following administration of dexamethasone 1 mg at 11 pm the night before and measurable plasma ACTH levels.
• Must have a pituitary tumor demonstrated on MRI performed with and without contrast
• Hypercortisolemic, and does not wish to receive alternate steroid lowering therapy such as ketoconazole and/or metryrapone.
• Must be minimum of 1 month after any recent pituitary surgery (study 2 only)

Number of patients: 15

Location:

UCLA- Principal Investigator: Anthony Heaney, MD

UCLA-Harbor Medical Center- Investigator: Christina Wang, MD

Enrollment Period: 2006-2009

For more information or subject referrals contact:

Shameka Faulkner, Study Coordinator
Telephone (310) 825-5874
Email:sfaulkner@mednet.ucla.edu
Fax: (310) 794-7654
Mailing address:
David Geffen School of Medicine at UCLA
900 Veteran ave, Warren Hall, Room 24-130
Los Angeles, CA 90095

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National Institute of Health
The National Institute of Health has ongoing research studies involving Cushing's. If patients fit into an existing research protocol, evaluation and treatment is free of charge. Interested patients or physicians can call the NIH recruitment line at 800-411-1222.

Patients with demonstrated high cortisol and no visible pituitary or ectopic tumor may be eligible an imaging study being conducted by Dr. Lynette Nieman - nieman@mail.nih.gov.

Pedriatic patients with demonstrated high cortisol may be eligible for pedriatic studies. Contact Meg Keil - keilm@cc1.nichd.nih.gov.

Clinical Trials Data Base
The NIH also maintains a data base for NIH studies and those underway at other centers.
www.clinicaltrials.gov.