Effects of Testosterone Replacement in Androgen-Deficient Women with Hypopituitarism: A Randomized, Double-Blind, Placebo-Controlled Study

Context: Hypopituitarism in women is characterized by profound androgen deficiency due to a loss of adrenal and/or ovarian function. The effects of testosterone replacement in this population have not been reported. Objective: The objective of the study was to determine whether physiologic testoster...

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Published in:	The journal of clinical endocrinology and metabolism 2006-05, Vol.91 (5), p.1683-1690
Main Authors:	Miller, K. K, Biller, B. M. K, Beauregard, C, Lipman, J. G, Jones, J, Schoenfeld, D, Sherman, J. C, Swearingen, B, Loeffler, J, Klibanski, A
Format:	Article
Language:	eng
Subjects:	Adrenal Insufficiency - etiology Adult Affect Androgens - blood Androgens - deficiency Arousal - physiology Biological and medical sciences Body Composition Bone Density Cognition - physiology Double-Blind Method Endocrinopathies Female Fundamental and applied biological sciences. Psychology Hormone Replacement Therapy Hormones - blood Humans Hypogonadism - etiology Hypopituitarism - blood Hypopituitarism - drug therapy Hypopituitarism - psychology Hypothalamus. Hypophysis. Epiphysis (diseases) Medical sciences Middle Aged Non tumoral diseases. Target tissue resistance. Benign neoplasms Sexual Behavior Testosterone - adverse effects Testosterone - blood Testosterone - therapeutic use Vertebrates: endocrinology
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Summary:	Context: Hypopituitarism in women is characterized by profound androgen deficiency due to a loss of adrenal and/or ovarian function. The effects of testosterone replacement in this population have not been reported. Objective: The objective of the study was to determine whether physiologic testosterone replacement improves bone density, body composition, and/or neurobehavioral function in women with severe androgen deficiency secondary to hypopituitarism. Design: This was a 12-month randomized, placebo-controlled study. Setting: The study was conducted at a general clinical research center. Study Participants: Fifty-one women of reproductive age with androgen deficiency due to hypopituitarism participated. Intervention: Physiologic testosterone administration using a patch that delivers 300 μg daily or placebo was administered. Main Outcome Measures: Bone density, fat-free mass, and fat mass were measured by dual x-ray absorptiometry. Thigh muscle and abdominal cross-sectional area were measured by computed tomography scan. Mood, sexual function, quality of life, and cognitive function were assessed using self-administered questionnaires. Results: Mean free testosterone increased into the normal range during testosterone administration. Mean hip (P = 0.023) and radius (P = 0.007), but not posteroanterior spine, bone mineral density increased in the group receiving testosterone, compared with placebo, as did mean fat-free mass (P = 0.040) and thigh muscle area (P = 0.038), but there was no change in fat mass. Mood (P = 0.029) and sexual function (P = 0.044) improved, as did some aspects of quality of life, but not cognitive function. Testosterone at physiologic replacement levels was well tolerated, with few side effects. Conclusions: This is the first randomized, double-blind, placebo-controlled study to show a positive effect of testosterone on bone density, body composition, and neurobehavioral function in women with severe androgen deficiency due to hypopituitarism.
ISSN:	0021-972X 1945-7197