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Biomedical subjects

A S Dobs

Publications and source records attributed to A S Dobs.

At least 19 recordsLinked to original sources
PubMed2006

Lipoprotein profile in men with prostate cancer undergoing androgen deprivation therapy.

Sex steroids are known to modulate serum lipoproteins. Studies have suggested that serum testosterone levels are associated with a beneficial lipid profile. Androgen deprivation therapy (ADT) is employed in the treatment of recurrent and metastatic prostate cancer (PCa), resulting in profound hypogonadism. As male hypogonadism unfavorably influences lipid profile and men with PCa have high cardiovascular mortality, we evaluated the effects of long-term ADT on fasting lipids. This Cross-sectional study was conducted in a university-based research institution. We evaluated 44 men, 16 undergoing ADT for at least 12 months before the study (ADT group), 14 age-matched eugonadal men with non-metastatic PCa who were status post prostatectomy and/or radiotherapy and not on ADT (non-ADT group) and 14 age-matched eugonadal controls (Control group). None of the men had known history of diabetes or dyslipidemia. Mean age was similar in the three groups (P = 0.37). Serum total (P < 0.01) and free (P < 0.01) testosterone levels were lower in the ADT group compared to the other groups. Men on ADT had higher body mass index (BMI) compared to the other groups (P < 0.01). Men in the ADT group had significantly higher levels of total cholesterol compared to the other two groups (P = 0.03). After adjustment for BMI, men on ADT continued to have significantly higher fasting levels of total cholesterol (P = 0.02), LDL cholesterol (P = 0.04) and non-HDL cholesterol (P = 0.03) compared to the control group. No significant differences were seen in the levels of other lipoproteins between the three groups. These data show that men undergoing long-term ADT have higher total and LDL cholesterol than age-matched controls. Long-term prospective studies are needed to determine the time of onset of changes in these lipoproteins while on ADT and the influence of these changes on cardiovascular mortality.

Aged↗
PubMed2006

Alternative therapies for osteoporosis.

A variety of common complementary and alternative medicine therapies are now being examined for effectiveness in the management of osteoporosis. Short-term studies in postmenopausal women show beneficial effects of soy isoflavone supplementation on bone density, but its long-term effects require clarification. Prospective controlled trials have shown that physical training can increase bone density to varying degrees. Other therapies that have been examined include herbal formulae, essential fatty acids and vitamins A, C, and K, but few data regarding their effectiveness, mechanisms and safety have been published. Further randomized controlled trials are needed.

Bone Density↗
PubMed2005

Body shape and composition in HIV-infected women: an urban cohort.

OBJECTIVES: Alterations in body shape and composition are associated with HIV/AIDS. Wasting remains prevalent; increasingly, lipodystrophy is reported. Obesity is also epidemic in the USA. In this study, we sought to characterize the body changes reported by women attending a US urban clinic, and to evaluate contributing factors using inexpensive methods that are readily available in clinical practice. METHODS: In an urban Maryland clinic, a cross-section of HIV-infected women were evaluated by self report, anthropomorphic measurements, bioelectric impedance analysis (BIA) and chart review; they were categorized as no change, lipodystrophy, weight loss/wasting or weight gain/obesity. RESULTS: One hundred and sixty-one women were evaluated: 144 (89%) were African-American; 100 (62%) had used intravenous drugs and 40 (25%) were actively injecting drugs, while 39 (24%) smoked crack. Ninety-five (59%) were on highly active antiretroviral therapy (HAART) for a median period of 11.7 months [interquartile range (IQR)=4.5-24.2]. Since starting current HAART or in the previous year, 12 (7.4%) reported lipodystrophy changes, 85 (52.8%) weight gain, 27 (16.8%) overall weight loss, and 37 (23.0%) no change. Lipodystrophy was associated with higher CD4 percentage (P=0.03), lower frequency of crack use (P=0.04) and higher educational level (P=0.03). Weight loss correlated with longer duration of infection (P=0.01), select BIA results and increased rate of crack use (P=0.005). Weight gain was associated with higher fat mass (P=0.005), higher peak viral load (P=0.02), and lower rate of intravenous drug use (P=0.03). CONCLUSIONS: Self-reported changes in body shape were common. Obesity and complications of illicit drug use were more prevalent than lipodystrophy in this inner-city population of HIV-positive women.

Adipose Tissue↗
PubMed2004

Short-term pharmacokinetic comparison of a novel testosterone buccal system and a testosterone gel in testosterone deficient men.

OBJECTIVE: The primary objective of the study was to compare the percentage of men with mean serum total T (C(ave(0-24))) within normal range during the 24-h pharmacokinetic (PK) sampling period on Days 14 and 15. METHODS: Treatment with a new testosterone (T) buccal system, (Striant), 30 mg twice daily was compared to a transdermal gel delivery system, (T-gel) [AndroGel 5 g containing 1% (50 mg) T] daily for 14 days in T-deficient men. Safety parameters included laboratory assessments and collection of adverse events. Patients were otherwise healthy T-deficient men with total T <or= 8.7 nmol/L (<or= 2.5 ng/mL). RESULTS: Twenty-six of the 28 patients enrolled (0.93 +/- 0.38 ng/mL) for T-gel, which was greater completed the 24-h PK assessment. Of the evaluable patients, 92.3% of T buccal system and 83.3% of T-gel patients had C(ave(0-24)) within the normal range of 10.4-36.4 nmol/L (3.0-10.5 ng/mL). Mean total T values were not different in the T buccal system group (C(ave(0-24)) 16.7 +/- 4.7 nmol/L; 4.8 +/- 1.4 ng/mL) compared to the T-gel group (C(ave(0-24)) 15.9 +/- 4.8 nmol/L; 4.6 +/- 1.4 ng/mL). All T values returned to baseline levels after the study drug was stopped. Serum LH and FSH levels decreased, and E(2) increased as expected following T administration. Differences in DHT concentrations between treatment groups were significant (p = 0.012) with mean DHT levels on Day 14 of 1.9 +/- 1.4 nmol/L (0.55 +/- 0.42 ng/mL) for the T buccal system and 3.2 +/- 1.3 nmol/L than the upper level of normal (2.9 nmol/L; 0.85 ng/mL). Statistically significant differences were seen in the mean T/DHT ratio on Days 14 and 15 with the T buccal system (9.3) and T-gel (5.0) (normal 9-12) (Day 14, p < 0.00001; Day 15, p < 0.0001). All adverse events were mild to moderate in severity. Three of 12 adverse events significant adverse effects in T-deficient men. The T were considered related to the study drug and included headache (1 for each of the T buccal system and T-gel), and breast pain (T-gel). SUMMARY AND CONCLUSIONS: In this short-term study, the T buccal system produced steady-state T levels comparable to those with T-Gel without buccal system provides an additional safe, effective and convenient option for testosterone replacement therapy in hypogonadal men.

Administration, Buccal↗
PubMed2001

Hypogonadism and androgen replacement therapy in elderly men.

The decrease in testosterone levels with age is both central (pituitary) and peripheral (testicular) origin. Because serum levels of sex-hormone-binding globulin increase with aging, the decrease in free testosterone is of even greater magnitude. Recent long-term studies of testosterone therapy in hypogonadal elderly men have shown beneficial effects on bone density, body composition, and muscle strength without any substantial adverse effects on lipids and the prostate. Total testosterone level is the test of choice for initial screening of elderly men who present with signs and symptoms of hypogonadism. If the level is below 300 ng/dL, replacement therapy should be initiated. If the level is normal in a symptomatic patient, free or bioavailable testosterone should be determined. The pros and cons of testosterone therapy should be discussed in depth with every patient, and decisions should be made on an individual basis. This review summarizes the trials of testosterone replacement therapy in elderly men and outlines a diagnostic approach to these patients.

Aged↗
PubMed2001

Post-menopausal hormone therapy and concentrations of protein C and antithrombin in elderly women.

The effects of post-menopausal hormone therapy (HRT) on blood coagulation in elderly women are not well defined. We studied associations of HRT use with levels of natural anticoagulant proteins in a cross-sectional study of 3393 women > or = 65 years of age participating in the Cardiovascular Health Study. Protein C antigen and antithrombin were measured in all users (n = 230 unopposed oestrogen; 60 oestrogen/progestin) and a comparison group of 196 age- and race-matched non-users. Compared with non-users, oestrogen use was associated with higher protein C (4.80 vs. 4.30 microg/ml, P < 0.01). Results were similar for oestrogen/progestin (P > 0.05). In both user groups, antithrombin was lower than in non-users (109% for each vs. 115% in non-users, P < 0.001). Adjustment for factors related to prescription of HRT and to anticoagulant protein levels had little impact on the results. For antithrombin, associations with HRT were larger for thinner Caucasian women and black women. Venous thrombosis from HRT may be mediated partly by alterations in antithrombin, but not protein C concentrations. This study extends previous observations to older women, the group at highest risk of venous thromboembolism. Studies of HRT-induced alterations in anticoagulant function in relation to the occurrence of thrombosis with HRT are required.

Aged↗
PubMed2001

Clinical review 138: Anabolic-androgenic steroid therapy in the treatment of chronic diseases.

The purpose of this study was to review the preclinical and clinical literature relevant to the efficacy and safety of anabolic androgen steroid therapy for palliative treatment of severe weight loss associated with chronic diseases. Data sources were published literature identified from the Medline database from January 1966 to December 2000, bibliographic references, and textbooks. Reports from preclinical and clinical trials were selected. Study designs and results were extracted from trial reports. Statistical evaluation or meta-analysis of combined results was not attempted. Androgenic anabolic steroids (AAS) are widely prescribed for the treatment of male hypogonadism; however, they may play a significant role in the treatment of other conditions as well, such as cachexia associated with human immunodeficiency virus, cancer, burns, renal and hepatic failure, and anemia associated with leukemia or kidney failure. A review of the anabolic effects of androgens and their efficacy in the treatment of these conditions is provided. In addition, the numerous and sometimes serious side effects that have been known to occur with androgen use are reviewed. Although the threat of various side effects is present, AAS therapy appears to have a favorable anabolic effect on patients with chronic diseases and muscle catabolism. We recommend that AAS can be used for the treatment of patients with acquired immunodeficiency syndrome wasting and in severely catabolic patients with severe burns. Preliminary data in renal failure-associated wasting are also positive. Advantages and disadvantages should be weighed carefully when comparing AAS therapy to other weight-gaining measures. Although a conservative approach to the use of AAS in patients with chronic diseases is still recommended, the utility of AAS therapy in the attenuation of severe weight loss associated with disease states such as cancer, postoperative recovery, and wasting due to pulmonary and hepatic disease should be more thoroughly investigated.

Anabolic Agents↗
PubMed2001

Interrelationships among lipoprotein levels, sex hormones, anthropometric parameters, and age in hypogonadal men treated for 1 year with a permeation-enhanced testosterone transdermal system.

Serum lipoproteins and cardiovascular risk are affected by endogenous and exogenous sex hormones. As part of a multicenter evaluation of a permeation-enhanced testosterone transdermal system (TTD), the interrelationships among serum lipoproteins, hormone levels, anthropometric parameters, and age were investigated in 29 hypogonadal men. Subjects (aged 21-65 yr) were first studied during prior treatment with im testosterone esters (IM-T), then during an 8-week period of androgen withdrawal resulting in a hypogonadal state (HG), and finally during a 1-yr treatment period with the TTD. Compared with treatment with IM-T, the HG period produced increases in high density lipoprotein [HDL; 12.0 +/- 1.6% (+/-SEM); P<0.001] and total cholesterol (4.2 +/- 1.9%; P: = 0.02) and a decrease in the cholesterol/HDL ratio (-9.7 +/- 2.8%; P = 0.02). Compared with the HG period, TTD treatment produced decreases in HDL (-7.6 +/- 2.5%; P = 0.002) and increases in the cholesterol/HDL ratio (9.0 +/- 2.5%; P = 0.01) and triglycerides (20.7 +/- 6.4%; P: = 0.03). Small decreases in total cholesterol (-1.2 +/- 1.8%; P: = 0.1) and low density lipoprotein (-0.8 +/- 2.6%; P = 0.07) were also observed during TTD, but did not reach statistical significance. Likewise, there were no significant differences between the IM-T and TTD treatments. Serum HDL levels showed a strong negative correlation with body mass index and other obesity parameters in all three study periods (r < -0.45; P < 0.02). During treatment with TTD, serum testosterone levels also correlated negatively with body mass index (r = -0.621; P < 0.001). As a consequence of these relationships, a positive trend was observed between HDL and testosterone levels during TTD treatment (r = 0.336; P = 0.07). Interestingly, the changes in lipoprotein levels during TTD treatment indicated a more favorable profile (decrease in cholesterol and low density lipoprotein levels) with increasing age of the patients. In hypogonadal men the effects of transdermal testosterone replacement on serum lipoproteins appear consistent with the physiological effects of testosterone in eugonadal men.

Administration, Cutaneous↗
PubMed2000

Gonadal hormone levels in injection drug users.

Levels of serum sex hormones, particularly testosterone, luteinizing hormone, and follicle-stimulating hormone, have been shown to change in various disease states. Hypogonadism has been well-documented in patients with HIV infection. As HIV infection and injection drug use are closely linked, we examined whether injection drug users (IDU's) exhibit hormone abnormalities. We evaluated men participating in the ALIVE study (AIDS Linked to Intravenous Experiences), a large cohort study conducted in Baltimore, MD. We found that 20% of 40 IDU subjects (20 HIV+, 20 HIV-) with a mean age 41.5+/-0.9, had low serum total testosterone concentration. We were unable to detect a direct correlation between drug use and hormone levels. Further study is needed on the hormonal milieu of the IDU patient.

Adult↗
PubMed2000

Acute and long-term effects of AIDS and injection drug use on gonadal function.

Hypogonadism has been observed in both the HIV-infected population and injection drug users (IDUs). Considering these populations in conjunction is essential because IDUs and HIV often occur in the same individual. Additionally, although the etiology of hypogonadism may be different in each population, its treatment with respect to the underlying condition is similar. The philosophy of both AIDS and IDU treatment has changed drastically in recent years, due to several factors. Survival rates of HIV patients have been steadily increasing, forcing a closer examination of the long-term effects of AIDS-related symptoms, and the quality of life issues associated therewith. In comparison, IDU is now viewed as a chronic addiction like that for alcoholism, which must be treated, rather than an untreatable personal problem. Therefore, it is logical that the endocrine and metabolic changes associated with both HIV and IDU should be examined to help alleviate these symptoms in a continuing effort to treat the underlying condition.

Acquired Immunodeficiency Syndrome↗
PubMed2000

A rare pituitary lesion.

The majority of the sellar masses are pituitary adenomas. Non-adenomatous hypophyseal lesions are rare and include lymphocytic hypophysitis, idiopathic giant cell hypophysitis and granulomatous hypophysitis. The latter include lesions caused by conditions like tuberculosis, sarcoidosis, syphilis, histiocytosis X and mycotic infections. We report a case of a Sudanese woman who presented with a pituitary mass (presumed preoperatively to be an adenoma) and underwent trans-sphenoidal surgery. The final histopathology showed tuberculous hypophysitis. The patient did not have history of prior exposure to tuberculosis nor any evidence of infection elsewhere in the body. We also briefly review the literature on pituitary tuberculomas.

Female↗
PubMed2000

Effects of simvastatin and pravastatin on gonadal function in male hypercholesterolemic patients.

Inhibition of cholesterol biosynthesis by hydroxymethyl glutaryl coenzyme A (HMG-CoA) reductase inhibitors could, in theory, adversely affect male gonadal function because cholesterol is a precursor of steroid hormones. The objective of this randomized double-blind trial was to compare the effects of simvastatin, pravastatin, and placebo on gonadal testosterone production and spermatogenesis. After a 6-week placebo and lipid-lowering diet run-in period, 159 male patients aged 21 to 55 years with type IIa or IIb hypercholesterolemia, low-density lipoprotein (LDL) cholesterol between 145 and 240 mg/dL, and normal basal levels of testosterone were randomly assigned to treatment with simvastatin 20 mg (n = 40), simvastatin 40 mg (n = 41), pravastatin 40 mg (n = 39), or placebo (n = 39) once daily. After 24 weeks of treatment, mean total cholesterol levels were decreased 24% to 27% and mean LDL cholesterol was decreased 30% to 34% in the 3 active-treatment groups (P < .001 for all comparisons to placebo). At 24 weeks, there were no statistically significant differences between the placebo group and any of the active-treatment groups for the change from baseline in testosterone, human chorionic gonadotropin (hCG)stimulated testosterone, free testosterone index, follicle-stimulating hormone (FSH), luteinizing hormone (LH), or sex hormone-binding globulin (SHBG). Moreover, there were no statistically significant differences at week 12 or week 24 for the change from baseline in sperm concentration, ejaculate volume, or sperm motility for any active treatment relative to placebo. Both simvastatin and pravastatin were well tolerated. In summary, we found no evidence for clinically meaningful effects of simvastatin or pravastatin on gonadal testosterone production, testosterone reserve, or multiple parameters of semen quality.

Adult↗
PubMed2000

Effects of high-dose simvastatin on adrenal and gonadal steroidogenesis in men with hypercholesterolemia.

In view of the role of both the de novo biosynthesis and receptor-mediated uptake of cholesterol for normal steroidogenesis, we evaluated whether extending the therapeutic dose of the hepatic hydroxymethyl glutaryl coenzyme A (HMG-CoA) reductase inhibitor, simvastatin, to 80 mg/d would affect adrenal and gonadal steroid synthesis in men with hypercholesterolemia. To evaluate this question, we enrolled men into a multicenter randomized, placebo-controlled study lasting 12 weeks. Men with serum low-density lipoprotein cholesterol (LDL-C) more than 145 mg/dL after 6 weeks of a lipid-lowering diet were randomized to 80 mg simvastatin or placebo. Half of the subjects were asked to undergo a 6-hour infusion of corticotropin (ACTH) to evaluate cortisol synthesis, and the entire cohort received a human chorionic gonadotropin (hCG) stimulation test to assess gonadal hormone secretion using pooled serum samples taken 15 minutes apart. A total of 81 men (age, 45 +/- 11 years; 93% Caucasian) with baseline serum LDL-C of 197 mg/dL (placebo, n = 39) and 184 mg/dL (simvastatin 80 mg, n = 42) completed the study. After 12 weeks, serum LDL-C, triglycerides, and high-density lipoprotein cholesterol (HDL-C) in the simvastatin group changed by -43%, -25%, and 8%, respectively (all P < .001). The basal cortisol level and the peak serum cortisol and area under the curve response to the 6-hour ACTH infusion were comparable between the two treatment groups at baseline and after 12 weeks. The pooled total testosterone level at baseline was 541 and 513 ng/dL in the placebo and simvastatin-treated groups, respectively, which declined to 536 +/- 20.5 ng/dL (-1.5%) and 474 +/- 30.4 ng/dL (-13.6%, P = .09) after treatment (mean +/- SD). The pooled free testosterone declined by 6.3% in the simvastatin group, versus a 4.9% increase in the placebo group (P = .588), while pooled bioavailable testosterone declined 10.2% in the simvastatin group and increased 1.4% in the placebo group (P = .035). There were no changes in serum gonadotropin levels or sex hormone-binding globulin (SHBG). After administration of hCG, there were no differences in the peak total pooled testosterone level before or after 12 weeks of treatment. Simvastatin 80 mg was well tolerated compared with placebo. In conclusion, basal and stimulated cortisol production was unaffected by the use of simvastatin 80 mg versus placebo. As reported with other statins and cholestyramine, there were small declines in the simvastatin-treated group for pooled total, free, and bioavailable testosterone after 12 weeks, although there was no compensatory increase in serum follicle-stimulating hormone (FSH) or luteinizing hormone (LH) levels.

Adrenal Cortex↗
PubMed1999

Risk factors for popliteal and carotid wall thicknesses in the Atherosclerosis Risk in Communities (ARIC) Study.

The authors evaluated risk factors potentially associated with the development of popliteal artery atherosclerosis in a population-based study and compared them with factors linked to carotid wall intimal-medial thickness. The Atherosclerosis Risk in Communities (ARIC) Study is a longitudinal investigation of cardiovascular disease in 15,800 individuals. The present analyses are based on the baseline popliteal and carotid ultrasonography examination in 10,002 subjects conducted in 1987-1989. After adjustment for covariates, both carotid and popliteal intimal-medial thicknesses were strongly associated with male sex and age (p < 0.01), having a graded relation with increasing quartiles of plasma total cholesterol and low density lipoprotein cholesterol and with plasma triglycerides (women only for popliteal) (p < 0.01). An inverse correlation was noted between plasma high density lipoprotein cholesterol and carotid (p < 0.01) and popliteal (women only) (p < 0.05) intimal-medial thicknesses. Cigarette use (p < 0.01), a history of diabetes mellitus (p < 0.01), alcohol use, elevated systolic pressures (p < 0.01), and fibrinogen levels (p < 0.01) were directly associated with both popliteal and carotid intimal-medial thicknesses. Although menopause was associated with thickened carotid (p < 0.01) and popliteal (p < 0.05) intimal-medial thicknesses, hormone replacement therapy was associated with thinner carotid walls only (p < 0.05). Although there were some differences, many of the classical risk factors associated with cardiovascular disease were also related to early thickening of both the popliteal and the carotid artery walls.

Age Factors↗
PubMed1999

The use of a transscrotal testosterone delivery system in the treatment of patients with weight loss related to human immunodeficiency virus infection.

PURPOSE: Weight loss is a strong predictor of morbidity and mortality in human immunodeficiency virus (HIV)-infected patients. Men with acquired immunodeficiency syndrome (AIDS) lose body cell mass. Hypogonadism is also common. This study tested the efficacy of a testosterone transscrotal patch (6 mg/day) in improving body cell mass and treating hypogonadism in these patients. SUBJECTS AND METHODS: This multicenter, randomized, double-blinded, placebo-controlled trial was conducted from August 1995 to October 1996 in 133 men, 18 years of age and older, who had AIDS, 5% to 20% weight loss, and either a low morning serum total testosterone level (<400 ng/dL) or a low free testosterone level (<16 pg/mL). Outcomes included weight, body cell mass as measured using bioelectrical impedance analysis, quality of life, and morning measurements of serum testosterone and dihydrotestosterone levels, lymphocyte subsets, and HIV quantification. RESULTS: There were no significant differences in baseline weight, CD4 cell counts, or HIV serum viral quantification between treatment arms. Morning total and free testosterone levels increased in those treated with testosterone, but not with placebo. Following 12 weeks of treatment there were no differences (testosterone-placebo) in mean weight change (-0.3 kg [95% confidence interval (CI): -1.4 to 0.8]) or body cell mass (-0.2 kg [95% CI: -1.0 to 0.6]) in the two groups. There were also no changes in quality of life in either group. CONCLUSION: Hypogonadal men with AIDS and weight loss can achieve adequate morning serum sex hormone levels using a transscrotal testosterone patch. However, this system of replacement does not improve weight, body cell mass, or quality of life.

Adult↗
PubMed1999

Hormone replacement therapy, inflammation, and hemostasis in elderly women.

Lipid-lowering by postmenopausal hormone therapy (HRT) explains only partly the assumed coronary risk reduction associated with therapy. To explore other possible mechanisms, we studied associations of HRT use with inflammation and hemostasis risk markers in women >/=65 years of age. Subjects were selected from 3393 participants in the fourth year examination of the Cardiovascular Health Study, an observational study of vascular disease risk factors. After excluding women with vascular disease, we compared levels of inflammation and hemostasis variables in the 230 women using unopposed estrogen and 60 using estrogen/progestin, with those of 196 nonusers selected as controls. Compared with nonusers, unopposed estrogen use was associated with 59% higher mean C-reactive protein (P<0.001), but with modestly lower levels of other inflammation indicators, fibrinogen, and alpha-1 acid glycoprotein (P<0.001). Factor VIIc was 16% higher among estrogen users (P<0.001), but this was not associated with higher thrombin production (prothrombin fragment 1-2), or increased fibrin breakdown (D-dimer). Concentration of plasminogen activator inhibitor-1 was 50% lower in both using groups (P<0.001) compared with nonusers, and this was associated with higher plasmin-antiplasmin complex: 8% higher in estrogen and 18% higher in estrogen/progestin users (P<0. 05). Relationships between the markers and hormone use were less pronounced in estrogen/progestin users, with no association for C-reactive protein except in women in upper 2 tertiles of body mass index (P for interaction, 0.02). The direction and strength of the associations of HRT use with inflammation markers differed depending on the protein, so it is not clear whether HRT confers coronary risk reduction through an inflammation-sensitive mechanism. Associations with hemostasis markers indicated no association with evidence of procoagulation and a possible association with increased fibrinolytic activity.

Aged↗
PubMed1999

Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injections of testosterone enanthate for the treatment of hypogonadal men.

The pharmacokinetics, efficacy, and safety of the Androderm testosterone (T) transdermal system (TTD) and intramuscular T enanthate injections (i.m.) for the treatment of male hypogonadism were compared in a 24-week multicenter, randomized, parallel-group study. Sixty-six adult hypogonadal men (22-65 years of age) were withdrawn from prior i.m. treatment for 4-6 weeks and then randomly assigned to treatment with TTD (two 2.5-mg systems applied nightly) or i.m. (200 mg injected every 2 weeks); there were 33 patients per group. Twenty-six patients in the TTD group and 32 in the i.m. group completed the study. TTD treatment produced circadian variations in the levels of total T, bioavailable T, dihydrotestosterone, and estradiol within the normal physiological ranges. i.m. treatment produced supraphysiological levels of T, bioavailable T, and estradiol (but not dihydrotestosterone) for several days after each injection. Mean morning sex hormone levels were within the normal range in greater proportions of TTD patients (range, 77-100%) than i.m. patients (range, 19-84%). Both treatments normalized LH levels in approximately 50% of patients with primary hypogonadism; however, LH levels were suppressed to the subnormal range in 31% of i.m. patients vs. 0% of TTD patients. Both treatments maintained sexual function (assessed by questionnaire and Rigiscan) and mood (Beck Depression Inventory) at the prior treatment levels. Prostate-specific antigen levels, prostate volumes, and lipid and serum chemistry parameters were comparable in both treatment groups. Transient skin irritation from the patches was reported by 60% of the TTD patients, but caused only three patients (9%) to discontinue treatment. i.m. treatment produced local reactions in 33% of patients and was associated with significantly more abnormal hematocrit elevations (43.8% of patients) compared with TTD treatment (15.4% of patients). Gynecomastia resolved more frequently during TTD treatment (4 of 10 patients) than with i.m. treatment (1 of 9 patients). Although both treatments seem to be efficacious for replacing T in hypogonadal men, the more physiological sex hormone levels and profiles associated with TTD may offer possible advantages over i.m. in minimizing excessive stimulation of erythropoiesis, preventing/ameliorating gynecomastia, and not over-suppressing gonadotropins.

Administration, Cutaneous↗