Capsules USP, 10 mg C-III
The androgens are steroids that develop and maintain primary and secondary male sex characteristics. Androgens are derivatives of cyclopentanoperhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. In their active form, all drugs in the class have a 17-beta hydroxy group. 17-alpha alkylation (methylTESTOSTERone) increases the pharmacologic activity per unit weight compared to testosterone when given orally. MethylTESTOSTERone, a synthetic derivative of testosterone, is an androgenic preparation given by the oral route in a capsule form. Each capsule contains 10 mg of MethylTESTOSTERone USP.
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 administration. 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 benefitted 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 Android (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...
Effects of the addition of methyltestosterone to combined hormone therapy with estrogens and progestogens on sexual energy and on orgasm in postmenopausal women. [2008.02]
OBJECTIVE: To evaluate the effect of the addition of methyltestosterone to estrogen and progestogen therapy on postmenopausal sexual energy and orgasm... CONCLUSION: Addition of methyltestosterone to CEE/MPA therapy may increase sexual energy, but might not affect the ability to obtain orgasm in sexual relations.
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.
[Effects of growth hormone on anthropometric and metabolic parameters in android obesity] [2006.02]
The aim of the study was to evaluate the effect of GH on body weight, body composition and cardiovascular risk factors in android obese men. Forty non-diabetic subjects aged 20 to 50 years-old with android obesity (WHR > 1) were divided in two groups, on a prospective randomized double-blind basis to receive treatment with GH (0.050 U/kg/day) or placebo for three months...
Clinical Trials Related to Android (Methyltestosterone)
Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion [Recruiting]
The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal
Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or
Proliferative Diabetic Retinopathy (PDR).
Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC) [Recruiting]
Automated Closed-loop in Children and Adolescents With Type 1 Diabetes [Recruiting]
People with type 1 diabetes need regular insulin injections or continuous delivery of
insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term
complications. However, achieving treatment goals can be very difficult due to the risk of
low glucose levels (hypoglycaemia). One solution is to use a system where the amount of
insulin injected closely matches the blood sugar levels on a continuous basis. This can be
achieved by what is known as a "closed loop system" where a small glucose sensor placed
under the skin communicates with a computer containing an algorithm that drives a
subcutaneous insulin pump. Previous studies conducted under carefully controlled clinical
research facility environment, in Cambridge, United Kingdom, as well as several other
centres have shown that closed-loop glucose control is superior to usual insulin pump
therapy. The next logical step in the development pathway is to test closed loop systems in
the home environment. An essential requirement for conducting closed-loop studies outside
clinical research facility is an automated system where wireless data transmission takes
place between the glucose sensor and insulin pump.
The purpose of the present study is to evaluate the efficacy and safety of automated
overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel
system which has greatest potential for use in the home setting. The study will take place
at a clinical research facility on two occasions, using a standardised protocol. The
performance of the closed-loop system will be evaluated on day 1 of continuous glucose
monitoring (CGM) sensor life as compared to on days 3 to 4 of sensor life. Data and
experience gained from this study will be used for further refinements and development of
the system for future home use.
A Randomized Controlled Trial to Test the Effect of a Smartphone Quit Smoking Intervention on Young Adult Smokers [Recruiting]
The primary aim of this study will be to determine the effectiveness of a smartphone
delivered app for young adult smokers on quitting smoking.
Cancer Care Coordination for Chemotherapy Patients [Not yet recruiting]
The purpose of this study is to compare nurse-led care coordination for persons receiving
cancer chemotherapy treatment incorporating mobile health technology to nurse-led care
coordination without any mobile health enhancements.
Page last updated: 2011-12-09