Saturday, December 27, 2008

Clinical Trial: 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: The Charles Drew University of Medicine in Willowbrook and UCLA in West Los Angeles

Enrollment Period: Ongoing

Sponsors: NIH, Prostrakan, Genentech

Patient Compensation: Up to $1500

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


Fax: 323-563-9324

The Charles Drew University of Medicine and Sciences

1731 E. 120th St.

Los Angeles, California 90059