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PubMed2005

Impact of nicotine replacement therapy on smoking behavior.

This review summarizes evidence pertaining to the role of nicotine medications in smoking cessation and focuses particularly on evaluating evidence of the impact that nicotine replacement therapies (NRT) have had on altering population trends in smoking behavior. Accumulated evidence from controlled clinical trials has demonstrated that available forms of NRT (e.g., gum, transdermal patch, nasal spray, inhaler, and lozenge) increase quit rates compared with placebos by 50%-100%. However, despite the positive results from these studies, fewer than one in five smokers making a quit attempt do so with the benefit of NRT. Because not enough smokers are using NRT, the availability of NRT has not had a measurable impact on influencing population trends in smoking behavior. Among the factors contributing to the low utilization of nicotine medications are the inadequacies of the current dosage strengths and formulations of existing medications, smokers' perceptions of the high cost of the drugs, and concerns that many smokers have about safety and efficacy of nicotine medications.

Chemistry, Pharmaceutical↗
PubMed2006

Progesterone acutely increases LH pulse amplitude but does not acutely influence nocturnal LH pulse frequency slowing during the late follicular phase in women.

Progesterone (P) is the primary effector of LH (and by inference gonadotropin-releasing hormone) pulse frequency slowing in cycling women, but the time course of this action is unclear. We hypothesized that P administration to estradiol (E2)-pretreated women would slow LH pulse frequency within 12 h. We studied eight normally cycling women in two separate cycles (follicular phase, cycle days 7-11). After 3 days of E2 pretreatment (0.2 mg/day via transdermal patches), a 25-h blood sampling protocol (starting at 0800) was performed to define LH pulsatility. Oral micronized P (100 mg) or placebo (PBO) was administered at 1800 in a randomized, double-blind fashion, with treatment crossover occurring during a subsequent cycle. The 10-h mean P concentration increased from 0.6+/-0.1 ng/ml before P (0800-1800) to 3.9+/-0.3 ng/ml after P administration (2200-0800, P<0.01). Ten-hour mean LH interpulse interval increased significantly after both P and PBO administration, with no significant difference between P and PBO. In contrast, mean LH, LH amplitude, and mean FSH increased significantly within 4 h of P administration, but not after PBO. We conclude that, in E2-pretreated women in the late follicular phase, 1) nocturnal LH pulse frequency is not acutely (within 12 h) influenced by P administration; 2) an acute increase in P causes pronounced augmentation of gonadotropin pulse amplitude within 4 h; and 3) LH pulse frequency slows overnight during the second half of the follicular phase.

Administration, Oral↗
PubMed1998

Estrogen influences osmotic secretion of AVP and body water balance in postmenopausal women.

To determine if estrogen upregulates osmotic secretion of arginine vasopressin (AVP) and alters body water balance, we infused hypertonic (3% NaCl) saline in 6 women (68 +/- 3 yr) after 14 days of 17 beta-estradiol (transdermal patch, approximately 0.1 mg/day, E2) and placebo (control) administration. Hypertonic saline was infused at 0.1 ml.kg-1.min-1 for 120 min, and after a 30-min equilibration period, the subjects drank water ad libitum for 180 min. E2 increased basal plasma estradiol concentration from < or = 12 to 80 +/- 12 pg/ml and plasma AVP concentration (P[AVP]) from 2.1 +/- 0.7 to 3.1 +/- 0.8 pg/ml (P < 0.05), but not plasma osmolality (Posm, 288 +/- 1 and 287 +/- 1, for control and E2, respectively). Hypertonic saline infusion increased Posm by 18 +/- 1 and 17 +/- 1 mosmol/kgH2O and P[AVP] by 5.2 +/- 0.5 and 4.9 +/- 0.4 pg/ml for control and E2 treatments, respectively. The P[AVP]-Posm relationship shifted upward after E2, with no change in sensitivity (slope, 0.36 +/- 0.02 and 0.33 +/- 0.03 pg.ml-1.mosmol-1 for control and E2, respectively). Water intake was similar between control and E2 (24 vs. 22 ml/kg), but by 180 min of drinking, urine output and free water clearance (CH2O) were reduced by 5.6 +/- 2.3 ml/kg and 2.6 +/- 2.0 ml/min, respectively (P < 0.05) after E2. Plasma aldosterone concentration was unaffected by E2, but fractional sodium excretion was reduced from 2.7 +/- 0.5 to 1.7 +/- 0.4% (P < 0.05) at 180 min of drinking. Our data suggest that E2 augments osmotic AVP secretion, thereby implicating elevated AVP as a contributor to water retention in high E2 states; however, an increase in renal sodium reabsorption was a major component of the enhanced fluid retention.

Aldosterone↗
PubMed2001

Estrogen and progesterone effects on transcapillary fluid dynamics.

The purpose of this study was to determine estrogen (E(2)) and progesterone (P(4)) effects on atrial natriuretic peptide (ANP) control of plasma volume (PV) and transcapillary fluid dynamics. To this end, we suppressed reproductive function in 12 women (age 21-35 yr) using a gonadotropin releasing-hormone (GnRH) analog (leuprolide acetate) for 5 wk. During the 5th week, the women either received 4 days of E(2) administration (17beta-estradiol, transdermal patch, 0.1 mg/day) or 4 days of E(2) with P(4) administration (vaginal gel, 90 mg P(4) twice per day). At the end of the 4th and 5th week of GnRH analog and hormone administration, we determined PV (Evans blue dye) and changes in PV and forearm capillary filtration coefficient (CFC) during a 120-min infusion of ANP (5 ng x kg body wt(-1) x min(-1)). Preinfusion PV was estimated from Evans blue dye measurement taken over the last 30 min of infusion based on changes in hematocrit. E(2) treatment did not affect preinfusion PV relative to GnRH analog alone (45.3 +/- 3.1 vs. 45.4 +/- 3.1 ml/kg). During ANP infusion CFC was greater during E(2) treatment compared with GnRH analog alone (6.5 +/- 1.4 vs. 4.9 +/- 1.4 microl. 100 g(-1) x min(-1) mmHg(-1), P < 0.05). The %PV loss during ANP infusion was similar for E(2) and GnRH analog-alone treatments (-0.8 +/- 0.2 and -1.0 +/- 0.2 ml/kg, respectively), indicating the change in CFC had little systemic effect on ANP-related changes in PV. Estimated baseline PV was reduced by E(2)-P(4) treatment. During ANP infusion CFC was approximately 30% lower during E(2)-P(4) (6.0 +/- 0.5 vs. 4.3 +/- 4.3 microl. 100 g(-1) x min(-1) mm Hg(-1), P < 0.05), and the PV loss during ANP infusion was attenuated (-0.9 +/- 0.2 and -0.2 +/- 0.2 ml/kg for GnRH analog-alone and E(2)-P(4) treatments, respectively). Thus the E(2)-P(4) treatment lowered CFC and reduced PV loss during ANP infusion.

Adult↗
PubMed2002

Induction of puberty in the hypogonadal girl--practices and attitudes of pediatric endocrinologists in Europe.

The management of children and adolescents with hypogonadism and in particular the induction of puberty in the hypogonadal girl is subject to controversy. Therefore, under the auspices and through organization of the Drugs and Therapeutics Committee of the European Society of Paediatric Endocrinology (ESPE), an interactive voting session and workshop was held at the 39th ESPE Annual Meeting in Brussels to discuss these topics. Common practice in Europe and attitudes of pediatric endocrinologists in Europe were questioned and recorded in the 1.5-hour program. We now report on some of the results of the questionnaires and discussions of that session to further the discussion on and knowledge of current concepts of induction of puberty in the hypogonadal girl in Europe. It became clear from the data accumulated here that the start of treatment, the aims of therapy and the modalities of how to treat the hypogonadal girl vary amongst pediatric endocrinologists in Europe. For example, a chronological age > or =11 years was considered appropriate for the start of estrogen therapy by 40.4% (out of 188 answers), while 47.8 and 7.5% felt that a chronological age > or =13 and > or =15 years respectively was appropriate. In respect to the form and route of estrogen administration, the audience was asked for their common estrogen replacement practice: 31.9% used oral 17beta-estradiol treatment, while 10% would prescribe 17beta-estradiol transdermal patches. Another 12.2% would recommend conjugated estrogens (e.g. Premarin) orally, 4.8% use oral estradiol valerate and 39.3% ethinylestradiol orally. Only 1.8% out of 229 physicians answering were undecided. In addition, counseling of patients and their families is quite variable and perceptions for example regarding potential pregnancies in affected women are also not uniform. In this report the authors do not want to provide their own personal views but rather reflect current practice in Europe. It is hoped that a more uniform picture will emerge once European and international guidelines on how to treat the girl with hypogonadism will be available and even more discussions amongst doctors from different countries have been led.

Adolescent↗
PubMed1994

Transdermal fentanyl disposition in elderly subjects.

The pharmacokinetic characteristics of a 20-cm2 fentanyl 24-hour transdermal patch were compared between 10 healthy elderly subjects 67-87 years and 6 young subjects 19-27 years. All 10 elderly subjects required patch removal prior to 24 h due to adverse effects versus none of the young subjects. The mean patch duration (PD) in elderly subjects was 11.7 +/- 4.9 h, yielding a mean area under the curve from 0 to 60 h (AUC0-60) of 20.4 +/- 10.3 ng h/ml versus a mean AUC0-60 of 21.0 +/- 10.4 ng h/ml in young subjects. Correcting AUC0-60 for PD (AUC0-60/PD) gave a mean value of 2.05 +/- 1.10 ng/ml for elderly subjects, which was significantly greater than the AUC0-60/PD of 0.88 +/- 0.44 ng/ml in young subjects (p = 0.034, Student's t test). The higher serum concentrations reflect increased absorption and/or decreased clearance in the elderly.

Administration, Cutaneous↗
PubMed2000

Low-dose transdermal testosterone therapy improves angina threshold in men with chronic stable angina: A randomized, double-blind, placebo-controlled study.

BACKGROUND: Experimental studies suggest that androgens induce coronary vasodilatation. We performed this pilot project to examine the clinical effects of long-term low-dose androgens in men with angina. METHODS AND RESULTS: Forty-six men with stable angina completed a 2-week, single-blind placebo run-in, followed by double-blind randomization to 5 mg testosterone daily by transdermal patch or matching placebo for 12 weeks, in addition to their current medication. Time to 1-mm ST-segment depression on treadmill exercise testing and hormone levels were measured and quality of life was assessed by SF-36 at baseline and after 4 and 12 weeks of treatment. Active treatment resulted in a 2-fold increase in androgen levels and an increase in time to 1-mm ST-segment depression from (mean+/-SEM) 309+/-27 seconds at baseline to 343+/-26 seconds after 4 weeks and to 361+/-22 seconds after 12 weeks. This change was statistically significant compared with that seen in the placebo group (from 266+/-25 seconds at baseline to 284+/-23 seconds after 4 weeks and to 292+/-24 seconds after 12 weeks; P:=0.02 between the 2 groups by ANCOVA). The magnitude of the response was greater in those with lower baseline levels of bioavailable testosterone (r=-0. 455, P:<0.05). There were no significant changes in prostate specific antigen, hemoglobin, lipids, or coagulation profiles during the study. There were significant improvements in pain perception (P:=0.026) and role limitation resulting from physical problems (P:=0.024) in the testosterone-treated group. CONCLUSIONS: Low-dose supplemental testosterone treatment in men with chronic stable angina reduces exercise-induced myocardial ischemia.

Administration, Cutaneous↗
PubMed2006

Clonidine for the treatment of supine hypertension and pressure natriuresis in autonomic failure.

Patients with autonomic failure are disabled by orthostatic hypotension, which can be worsened by the nighttime pressure natriuresis induced by associated supine hypertension. Several pharmacological agents are available that effectively reduce nighttime hypertension, but none of them prevent pressure natriuresis. Because hypertension of autonomic failure can be driven by residual sympathetic tone, we hypothesized that clonidine would be effective in reducing blood pressure (BP) and nocturnal natriuresis. Therefore, we determined the effect of placebo, 0.1 mg clonidine, and 0.1-mg/h nitroglycerin transdermal patch on supine BP, orthostatic hypotension, and pressure natriuresis in 23 patients with primary autonomic failure and supine hypertension. Medications were given at 8:00 PM, and BP was recorded every 2 hours for 12 hours. The maximal decrease in BP was seen 6 to 8 hours after drug administration and was similar to clonidine and nitroglycerin (-29+/-9 and -30+/-10 mm Hg, respectively), as was the average fall in BP throughout the night. However, only clonidine effectively reduced nocturnal natriuresis (-0.09 mmol/mg Cr; 95% CI, -0.13 to -0.04; P=0.004), but this was not associated with improvement in morning orthostatic hypotension because of a residual hypotensive effect. The decrease in BP induced by clonidine was modestly but significantly correlated with the magnitude of residual sympathetic tone determined in 10 subjects by the fall in BP induced by ganglionic blockade (r=0.66; P=0.043). These results are consistent with residual sympathetic tone contributing to supine hypertension in autonomic failure, which can be targeted with clonidine to decrease BP and nocturnal natriuresis.

Aged↗
PubMed1997

Endogenous estrogen and acetylcholine-induced vasodilation in normotensive women.

Acute exogenous estrogen administration enhances endothelial function in postmenopausal women. To evaluate the effect of endogenous estrogen on endothelium-dependent vasodilation, in 10 fertile normotensive women (age range 45 to 51 years) we studied the changes in forearm blood flow (strain-gauge plethysmography) induced by intrabrachial acetylcholine (0.15, 0.45, 1.5, 4.5, 1.5 micrograms.100 mL-1.min-1), an endothelium-dependent vasodilator, or sodium nitroprusside (1, 2, 4 micrograms.100 mL-1.min-1), an endothelium-independent vasodilator, in basal conditions and within 1 month after ovariectomy. As control subjects, 10 matched healthy women were also evaluated. In basal condition, vasodilation to acetylcholine and sodium nitroprusside was similar in patients and control subjects. Ovariectomy was followed by endogenous estrogen deprivation (from 71.6 +/- 31.3 to < 12 pg/mL) and was associated with a significant (P < .01) reduction in acetylcholine-induced vasodilation compared with baseline (maximum percent increase in forearm blood flow: baseline 568.2 +/- 47.1%; ovariectomy 309.5 +/- 37.4%); the response to sodium nitroprusside was unaffected by ovariectomy (maximum percent increase in forearm blood flow: baseline 526.4 +/- 36.5%; ovariectomy 454.7 +/- 47.2%; P = NS). In 6 of 10 patients, the study was repeated after 3 months of estrogen replacement therapy (17 beta-estradiol, 50 micrograms/d by transdermal patches). Exogenous estrogen restored acetylcholine-induced vasodilation (maximum percent increase in forearm blood flow: 548.9 +/- 43.1%; P < .01 versus ovariectomy), which was no longer different from baseline, whereas the response to sodium nitroprusside was not affected (maximum percent increase in forearm blood flow: 480.2 +/- 39.3%; P = NS). These results suggest a protective role of endogenous estrogen on endothelium-dependent vasodilation in the forearm vascular bed of normotensive women.

Acetylcholine↗
PubMed1999

A pilot controlled clinical trial of ABT-418, a cholinergic agonist, in the treatment of adults with attention deficit hyperactivity disorder.

OBJECTIVE: Despite the increasing recognition of attention deficit hyperactivity disorder (ADHD) in adults, there is a paucity of controlled pharmacological trials. Recent reports have suggested the potential usefulness of cholinergic agents for ADHD. To this end, the authors completed a controlled study of ABT-418, a novel cholinergic activating agent, for the treatment of adults with ADHD. METHOD: This was a double-blind, placebo-controlled, randomized, crossover trial that compared a transdermal patch of ABT-418 (75 mg/day) to placebo in adults who met DSM-IV criteria for ADHD. There were two 3-week treatment periods separated by 1 week of washout. RESULTS: Of the 32 subjects enrolled in the study (88% were men; mean age = 40 years, SD = 9), 29 completed the study. At the endpoint of each active arm (last observation carried forward), a significantly higher proportion of subjects was considered improved while receiving ABT-418 than while receiving placebo (40% versus 13%). Similarly, at endpoint there was a significantly greater reduction in ADHD symptom checklist scores (28% versus 15%). Symptoms reflective of attention, and subjects with less severe ADHD, responded more robustly to ABT-418. Treatment with ABT-418 was relatively well tolerated; dizziness and nausea were the most frequently reported adverse effects. CONCLUSIONS: The results of this investigation indicate that ABT-418, a nicotinic analog, may be a potentially useful agent for the treatment of ADHD.

Administration, Cutaneous↗
PubMedDate not supplied

Topical nitric oxide application in the treatment of chronic extensor tendinosis at the elbow: a randomized, double-blinded, placebo-controlled clinical trial.

BACKGROUND: Extensor tendinosis ("tennis elbow") is a degenerative overuse tendinopathy of the wrist extensors at their attachment to the lateral humeral epicondyle. No treatment has been universally successful. Topical application of nitric oxide has been used effectively to treat fractures and cutaneous wounds in animal models, presumably by stimulation of collagen synthesis in fibroblasts. PURPOSE: To determine whether topical nitric oxide can improve outcome of patients with extensor tendinosis. STUDY DESIGN: Prospective, randomized, double-blinded clinical trial. METHODS: Eighty-six patients with extensor tendinosis were randomized into two equal groups; both were instructed to perform a standard tendon rehabilitation program. One group received an active glyceryl trinitrate transdermal patch, and the other group received a placebo patch. RESULTS: Patients in the glyceryl trinitrate group had significantly reduced elbow pain with activity at 2 weeks, reduced epicondylar tenderness at 6 and 12 weeks, and an increase in wrist extensor mean peak force and total work at 24 weeks. At 6 months, 81% of treated patients were asymptomatic during activities of daily living, compared with 60% of patients who had tendon rehabilitation alone. CONCLUSIONS: Application of topical nitric oxide improved early pain with activity, late functional measures, and outcomes of patients with extensor tendinosis.

Administration, Topical↗
PubMed1990

Self-injurious behavior associated with clonidine withdrawal in a child with Tourette's disorder.

A 7-year-old boy with Tourette's disorder, atypical pervasive developmental disorder, borderline mental retardation, and a history of self-injurious behavior was treated for 21 months with clonidine transdermal patches at doses ranging from 0.1 to 0.5 mg weekly. When withdrawn from clonidine over 4 weeks to assess the need for continued therapy, the patient developed multiple self-destructive behaviors involving the theme of suffocation. The importance of careful clinical monitoring of the behavior of patients undergoing withdrawal from prolonged treatment with high doses of clonidine is emphasized.

Arousal↗
PubMed1993

Randomized, controlled trial of transdermal clonidine for smoking cessation.

OBJECTIVE: To determine the efficacy and safety of clonidine versus placebo in smoking cessation. DESIGN: Single-center, randomized, double-blind, parallel-design comparison of transdermal clonidine with behavior modification, transdermal clonidine without behavior modification, placebo with behavior modification, and placebo without behavior modification. SETTING: Outpatient, university-based ambulatory care facility. PATIENTS: One hundred fifty generally healthy, highly nicotine-dependent cigarette smokers. INTERVENTION: Clonidine was given as the transdermal patch initiated 72 hours prior to smoking-cessation attempts and continued for six weeks thereafter. Clonidine was given at a dose of 0.2 mg/d for patients weighing more than 150 pounds (> 67.5 kg) and at a dose of 0.1 mg/d for patients weighing less than 150 pounds (< 67.5 kg). Behavior modification consisted of a total of 12 one-hour structured group training sessions. Patients not receiving behavior modification received printed material, which included the "Help Quit Kit" and the "I Quit Kit" from the American Cancer Society. MAIN OUTCOME MEASURES: Smoking-cessation rates were assessed at 6, 12, 24, and 52 weeks of follow-up. In addition, adverse reactions to clonidine or placebo were evaluated. RESULTS: Clonidine with behavior modification was statistically superior to the other three treatment groups but only at 6 weeks of follow-up. There were no differences in smoking-cessation rates among any of the treatment groups at any other follow-up intervals. Patients receiving behavior modification, regardless of whether they received clonidine, had better quit rates than patients not receiving behavior modification at all follow-up times except 52 weeks. Women receiving clonidine had significantly better quit rates than men receiving clonidine at all follow-up visits. Clonidine was associated with a significantly higher incidence of adverse effects than placebo (52 vs. 11 percent). However, the number of smokers withdrawing from the study was not greater with clonidine compared with placebo (9 vs. 7 percent, respectively). CONCLUSIONS: Clonidine is probably not effective as a pharmacologic adjunct to behavior modification in smoking cessation. It may have a potential role in women smokers who do not respond to or cannot tolerate more traditional smoking-cessation therapies.

Administration, Cutaneous↗
PubMedDate not supplied

The effect of mesalamine and nicotine in the treatment of inflammatory bowel disease.

OBJECTIVE: To characterize the usefulness of mesalamine and nicotine in the treatment of active ulcerative colitis and inactive Crohn's disease. DATA SOURCES: Citations were selected from the MEDLINE database. Only those involving human subjects, inflammatory bowel disease, and available in English were selected. STUDY SELECTION: Selection criteria of clinical trials and review articles assessing the effects of mesalamine and nicotine in active ulcerative colitis or inactive Crohn's disease and the utility of reducing steroid dependence or relapse rate. Less than 20% of the articles identified met the selection criteria. DATA SYNTHESIS: In patients with inactive Crohn's disease, mesalamine 2 g/d significantly reduced the risk of relapse in high-relapse-risk patients compared with placebo, reducing the relapse rate from 71% to 55%, but was ineffective in preventing recurrence of inactive Crohn's disease following surgical resection. Mesalamine 4 g/d was effective in decreasing weaning failure due to steroid dependence by 67%, although the relapse rate was not significant compared with placebo at the end of 12 months. Following surgical resection, mesalamine was unable to significantly reduce the incidence of recurrence compared with placebo at the end of 1 year. In patients with active ulcerative colitis, oral mesalamine 2 and 4 g/d was superior to placebo in inducing remission compared with placebo. Among patients with prior steroid of sulfasalazine treatment, rectal mesalamine 4 g hs achieved a remission rate of 78% in more than 12 weeks of therapy. Other studies have not found a dose-response relationship with lower dosages of mesalamine. Whereas nicotine 15-25 mg/d administered as a transdermal patch produced greater symptomatic improvement in active ulcerative colitis compared with placebo, nicotine 15 mg/16 h produced results no different from those with placebo in maintaining remission in active colitis. Nicotine appears to have an adverse effect on the course of Crohn's disease and is not recommended. CONCLUSIONS: Mesalamine has demonstrated clinical effectiveness as a therapeutic agent in the treatment of active ulcerative colitis and inactive Crohn's disease. Although its relationship to inflammatory bowel disease has been known for many years, the usefulness of nicotine for the treatment of active ulcerative colitis requires further exploration before it can be recommended as therapeutic agent.

Administration, Cutaneous↗
PubMedDate not supplied

Contemporary smoking cessation.

BACKGROUND: Tobacco smoking is the single most preventable cause of death in the United States today. Oncologists are in a unique position to affect the health and economic burdens of smoking by encouraging cessation among their patients who smoke. METHODS: The authors describe and review the effectiveness of current smoking cessation interventions as well as strategies that can be used to encourage cessation among patients. Three types of smoking cessation interventions are described: minimal (or self-help) interventions, behavioral interventions, and pharmacotherapy. The effectiveness of combinations of these types of treatments is also discussed. RESULTS: Oncology professionals can improve their patients' chances for success by implementing various cost-effective and easily executed smoking cessation interventions. Advice from a physician to quit smoking has resulted in long-term quit rates of up to 10.2%, and nicotine transdermal patches, nicotine gum, inhalers, and nasal sprays are also effective. CONCLUSIONS: Oncologists are encouraged to adopt the "4As" treatment protocol recommended by the National Cancer Institute: ask patients about their smoking status, advise them to quit, assist by recommending pharmacotherapy, counseling, and psychosocial self-help materials, and arrange follow-up.

Behavior Therapy↗
PubMed2004

Long-term neurobehavioral effects of alcohol or nicotine exposure in adolescent animal models.

Adolescent alcohol and nicotine abuse is common, but its neurodevelopmental consequences remain unclear. This laboratory utilized adolescent rodent models to assess the hypothesis that adolescents are highly susceptible to the effects of alcohol and nicotine. Rats were exposed to ethanol for 10-14 days using an intermittent vapor inhalation paradigm. Rats were continuously exposed to nicotine for 5 days using Nicoderm CQ transdermal patches. Alcohol or nicotine exposure altered neurobehavioral function when assessed after 3-7 weeks of abstinence. Alcohol-induced changes include increased electroencephalographic (EEG) frequency, decreased amplitude of the cortical N1 and hippocampal P3 event-related potential (ERP) components, enhanced anxiety-like behavior, and enhanced depressive-like behavior. Nicotine-induced changes include decreased slow-wave cortical EEG power, increased cortical N1 ERP amplitude, decreased motor activity, and increased anxiety-like behavior. These findings support the hypothesis that adolescents are uniquely susceptible to the effects of chronic alcohol and nicotine exposure.

Administration, Cutaneous↗
PubMed2005

The effects of growth hormone and/or testosterone in healthy elderly men: a randomized controlled trial.

CONTEXT: Declines in GH and testosterone (Te) secretion may contribute to the detrimental aging changes of elderly men. OBJECTIVE: To assess the effects of near-physiological GH with/without Te administration on lean body mass, total body fat, midthigh muscle cross-section area, muscle strength, aerobic capacity, condition-specific quality of life (Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire), and generic health status (36-Item Short-Form Health Survey) of older men. DESIGN, SETTINGS, AND PARTICIPANTS: A 6-month, randomized, double-blind, placebo-controlled trial was performed on 80 healthy, community-dwelling, older men (age, 65-80 yr). INTERVENTIONS: Participants were randomized to receive 1) placebo GH or placebo Te, 2) recombinant human GH (rhGH) and placebo Te (GH), 3) Te and placebo rhGH (Te), or 4) rhGH and Te (GHTe). GH doses were titrated over 8 wk to produce IGF-I levels in the upper half of the age-specific reference range. A fixed dose of Te (5 mg) was given by transdermal patches. RESULTS: Lean body mass increased with GHTe (P = 0.008) and GH (P = 0.004), compared with placebo. Total body fat decreased with GHTe only (P = 0.02). Midthigh muscle (P = 0.006) and aerobic capacity (P < 0.001) increased only after GHTe. Muscle strength changes were variable; one of six measures significantly increased with GHTe. Significant treatment group by time interactions indicated an improved Age-Related Hormone Deficiency-Dependent Quality of Life questionnaire score (P = 0.007) in the GH and GHTe groups. Bodily pain increased with GH alone, as determined by the Short-Form Health Survey (P = 0.003). There were no major adverse effects. CONCLUSION: Coadministration of low dose GH with Te resulted in beneficial changes being observed more often than with either GH or Te alone.

Aged↗
PubMed1999

Clinical trial of transdermal testosterone and oral levonorgestrel for male contraception.

Approaches to hormonal male contraception are predominantly based on injectable testosterone (T) application. As most users would prefer an injection-independent modality, this study was designed to develop a self-applicable hormonal male contraceptive regimen by combining transdermal T with an oral gestagen. Eleven healthy men (23-40 yr old) were treated with oral levonorgestrel and transdermal T for 24 weeks. T was applied daily as a transdermal patch to be worn on the trunk. Levonorgestrel was taken orally at a dose of 250 microg daily up to week 12, followed by 500 microg to week 24 in those volunteers who had not become azoospermic by that time. Within 24 weeks, 2 of 11 volunteers had become azoospermic, and 3 of 11 showed sperm concentrations below 3 million/mL. The sperm concentrations of the remaining volunteers declined, but failed to reach the limit considered compatible with contraception by WHO. Treatment resulted in suppression of LH, FSH, and sex hormone-binding globulin, whereby the volunteers with lower sperm concentrations showed more pronounced suppression than the others. Mean T concentrations remained within the lower limit of normal and on occasions were below this level. There were no complaints of hypoandrogenism. Although mean levels of low density lipoprotein cholesterol, apolipoprotein B, as well as basal and postprandial insulin increased, high density lipoprotein cholesterol and apolipoprotein A-I decreased during the treatment phase. Changes in lipid parameters were normalized within 3 weeks after cessation of medication. Although only 5 of 11 volunteers reached the target sperm counts (<3 million/mL), the study shows that a self-applicable hormonal male contraceptive could be developed.

Administration, Cutaneous↗