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
Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts 02114, USA.
J Clin Endocrinol Metab. 2006 May;91(5):1683-90. doi: 10.1210/jc.2005-2596. Epub 2006 Feb 14.
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.
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.
This was a 12-month randomized, placebo-controlled study.
The study was conducted at a general clinical research center.
Fifty-one women of reproductive age with androgen deficiency due to hypopituitarism participated.
Physiologic testosterone administration using a patch that delivers 300 microg daily or placebo was administered.
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.
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.
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.
女性垂体功能减退的特征是由于肾上腺和/或卵巢功能丧失导致严重雄激素缺乏。该人群中睾酮替代治疗的效果尚未见报道。
本研究的目的是确定生理剂量的睾酮替代治疗是否能改善继发于垂体功能减退的严重雄激素缺乏女性的骨密度、身体组成和/或神经行为功能。
这是一项为期12个月的随机、安慰剂对照研究。
该研究在一个综合临床研究中心进行。
51名因垂体功能减退导致雄激素缺乏的育龄女性参与了研究。
使用每日释放300微克的贴片给予生理剂量的睾酮或安慰剂。
通过双能X线吸收法测量骨密度、去脂体重和脂肪量。通过计算机断层扫描测量大腿肌肉和腹部横截面积。使用自填问卷评估情绪、性功能、生活质量和认知功能。
在给予睾酮期间，平均游离睾酮升高至正常范围。与安慰剂组相比，接受睾酮治疗的组平均髋部（P = 0.023）和桡骨（P = 0.007）骨矿物质密度增加，而脊柱前后位骨矿物质密度未增加，平均去脂体重（P = 0.040）和大腿肌肉面积（P = 0.038）也增加，但脂肪量无变化。情绪（P = 0.029）和性功能（P = 0.044）有所改善，生活质量的某些方面也有所改善，但认知功能未改善。生理替代水平的睾酮耐受性良好，副作用很少。
这是第一项随机、双盲、安慰剂对照研究，表明睾酮对继发于垂体功能减退的严重雄激素缺乏女性的骨密度、身体组成和神经行为功能有积极影响。
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