The androgens are steroids that develop and maintain primary and secondary male sex characteristics.
Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone;
Primary hypogonadism (congenital or acquired)--testicular failure due to cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome; or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired)--idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation.
If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen adminstration. An X-ray of the hand and wrist to determine bone age should be obtained every 6 months to assess the effect of treatment on the epiphyseal centers (see WARNINGS).
Androgens may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.
Published Studies Related to Methyltestosterone
Safety and efficacy of low-dose esterified estrogens and methyltestosterone, alone or combined, for the treatment of hot flashes in menopausal women: a randomized, double-blind, placebo-controlled study. [2011.01]
This study evaluated safety and efficacy of esterified estrogens and methyltestosterone administered alone or in combination for the treatment of hot flashes in menopausal women. The 0.30-mg esterified estrogens and 0.30-mg methyltestosterone combination was the lowest effective dose, and our results are consistent with the known safety profile of estrogen and androgen combination products.
Effects of methyltestosterone on immunity against Salmonella Pullorum in dwarf chicks. [2009.12]
This study was conducted to determine effects of methyltestosterone on innate immunity and adaptive immunity against Salmonella Pullorum in dwarf chicks. In vivo experiment, comparisons of pathological sections, viable counts of bacteria, specific antibody levels, and subsets of T lymphocytes were set forth between chicks with or without 10(-7) M methyltestosterone treatment (2 d of age through 21 d of age) and challenged with 5 x 10(8) virulent Salmonella Pullorum (7 d of age), and in vitro experiment, phagocytic and killing abilities, reactive oxygen intermediate production, and reactive nitrogen intermediate production of monocytes-macrophages treated with high (10(-8) M/10(6) cell) or physiological (10(-14) M/10(6) cell) concentration of methyltestosterone were examined after Salmonella Pullorum infection...
Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: a double-blind controlled pilot study. [2006.03]
OBJECTIVE: This study evaluated the augmentation of venlafaxine with hormone therapy in the treatment of postmenopausal depression. The hormones evaluated were estrogen (0.625 mg) in combination with medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg)... CONCLUSIONS: Methyltestosterone 2.5 mg had the highest effect size compared with placebo, but the high dropout rate prevented its efficacy from being determined. Estrogen plus medroxyprogesterone, combined with methyltestosterone or otherwise, demonstrated a trend toward increased efficacy of venlafaxine. Further larger-scale clinical trials are needed to elucidate the findings of this pilot study.
Combined esterified estrogens and methyltestosterone versus esterified estrogens alone in the treatment of loss of sexual interest in surgically menopausal women. [2005.07]
OBJECTIVE: To compare the effect of esterified estrogens and methyltestosterone versus esterified estrogens alone on diminished sexual interest in surgically menopausal women... CONCLUSIONS: The mixed results seen with the different sexual function questionnaires may be due to the CSFQ-F-C's lack of specificity for this population. Increased levels of bioavailable and free testosterone paralleled the improved MSIQ item scores. Both the EE and EE/MT treatments were well tolerated.
Combined esterified estrogen and methyltestosterone treatment for dry eye syndrome in postmenopausal women. [2005.06]
PURPOSE: To determine whether systemic replacement with combined esterified estrogen (EE) and methyltestosterone (MT) (EE + MT) would reduce symptoms and promote clinical improvement in postmenopausal women with dry eye syndrome (DES). DESIGN: Retrospective, noncomparative, interventional case series... CONCLUSIONS: Treatment with EE + MT may be efficacious for DES of various etiologies. A randomized placebo-controlled trial is planned to further evaluate these encouraging findings.
Clinical Trials Related to Methyltestosterone
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism [Active, not recruiting]
This is to study the effect of replacing testosterone on different inflammatory cells in
type 2 diabetics with low testosterone levels.
Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women [Completed]
Female sexual dysfunction (FSD) is an established side effect of Selective serotonin
reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing
symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.
Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder
(HSDD) in women has been demonstrated in studies including naturally and surgically
menopausal women, either alone or in combination with estrogen, with or without progestin
TRADE-Testosterone Replacement and Dutasteride Effectiveness [Completed]
The purpose of this research study is to determine whether the combination of the male
hormone testosterone [T] in gel form and the oral drug dutasteride [D], used to shrink large
prostate glands can safely reduce the size of the prostate gland and symptoms of prostate
enlargement (called benign prostatic hyperplasia [BPH]) compared to T treatment alone in men
with low testosterone (called hypogonadism).
Pharmacokinetic Study of Testosterone Enanthate [Completed]
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [Recruiting]
Skeletal muscle loss is a common consequence of aging and in some individuals reaches a
level that compromises health and quality of life. Age-associated increases in cytokine and
inflammatory signaling may be important contributors to this process. In this project the
investigators will test the hypotheses that 1) testosterone will inhibit cytokine and
inflammatory signaling in skeletal muscles of older adults and 2) will augment the anabolic
response to increased skeletal muscle activity. The investigators will also assess the
practical question of whether testosterone injection and gel application elicit similar
responses. Resistance exercise will be used as a means of stimulating both inflammatory and
anabolic responses in skeletal muscle. In order to assess the effects of testosterone on
these responses, fourteen subjects will perform resistance exercise on two occasions
separated by 7 days. The first session will be performed prior to the initiation of
testosterone therapy and the second session will be performed after receiving testosterone
for 7 days.
Page last updated: 2011-12-09