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PubMedDate not supplied

Influence of transdermal estradiol in the regulation of leptin levels of postmenopausal women: a double-blind, placebo-controlled study.

OBJECTIVE: To investigate whether the administration of transdermal estradiol is capable of modifying circulating levels of leptin. DESIGN: Forty postmenopausal women randomly received in a double-blind fashion, a transdermal patch containing either placebo or estradiol (50 microg/day). After 2 months of treatment, they were switched to the alternate treatment for another 2 months. Leptin levels were measured at the end of the placebo and estradiol administration. In a subset of 28 women an evaluation of body composition via bioelectrical impedance and an oral glucose tolerance test (OGTT; 75 g) were also performed at the end of the placebo and estradiol administration. Glucose, insulin, and leptin levels were measured in all OGTT samples. RESULTS: Leptin levels were related directly to body mass index (BMI), fat mass, and insulin, and inversely related to lean mass. In comparison to placebo, transdermal estradiol increased estradiol (from 77.8 +/- 8.4 pmol/l to 183.1 +/- 20.9 pmol/l; p < 0.0001) but did not significantly modify leptin (19.1 +/- 2.4 microg/l vs. 18.6 +/- 2 microg/l) or BMI. Estradiol did not modify fat mass or lean mass, significantly increased intracellular water (31.1 +/- 0.7% vs. 37.2 +/- 2.3%, p < 0.05), and decreased extracellular water (40.5 +/- 0.7% vs. 36.3 +/- 1.7%; p < 0.04). Leptin did not increase during OGTT, but a significant decrease, linearly related to BMI ( r = 0.519; p = 0.0189), was observed at the end of the test. CONCLUSIONS: Low doses of transdermal estradiol exert no influence on fasting leptin levels or BMI. The possibility that different doses of estradiol exert a more pronounced effect on circulating leptin needs to be addressed in comparative studies.

Administration, Cutaneous↗
PubMed1985

Nitrate tolerance.

Nitrate tolerance may be defined as that condition in which increasing nitrate doses are required to induce a given hemodynamic or antianginal effect. Tolerance may be due to changes in pharmacokinetics or to alterations in the property of target tissues, making them less sensitive to the nitrate effect. The question of nitrate tolerance has been addressed using 4-times-a-day therapy with oral isosorbide dinitrate, daily therapy with long-acting isosorbide dinitrate ointment and once-a-day therapy with nitroglycerin patches. Each of these treatment modalities is associated with initial beneficial effects, but during sustained therapy, there is marked attenuation of the effect both in magnitude and duration. Thus the concept that stable nitroglycerin blood levels over 24 hours are desirable appears to be incorrect. Preliminary hemodynamic studies suggest that short periods of nitrate withdrawal restore the hemodynamic effect of the nitrates, and it is postulated that intermittent nitrate therapy may be desirable in the management of angina. Transmucosal nitroglycerin administration for a 15-hour period with a 9-hour washout period was recently undertaken. The results demonstrated that this method of nitrate administration is not associated with development of tolerance to its antianginal effects. Large doses of transdermal nitroglycerin, varying from 45 to 100 mg during short-term studies, have been shown to result in only minimal increases in exercise tolerance at 24 hours. These findings, plus evidence that with smaller doses tolerance occurs after only 1 week of once-a-day therapy, challenge the concept that larger nitroglycerin dosages, administered once a day by transdermal patches, could be effective throughout a 24-hour period in patients with angina pectoris.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Topical↗
PubMed1986

Increased uptake of transdermal glyceryl trinitrate during physical exercise and during high ambient temperature.

In a study of GTN absorption during exercise and high ambient temperature, 12 healthy volunteers carried 10 mg glyceryl trinitrate (GTN, nitroglycerin) transdermal patches for 6 hours during each of 3 days. During a control day the mean plasma GTN concentration ranged from 1.0 nmol/L (SD +/- 0.8 nmol/L) to 1.5 nmol/L (SD +/- 1.0 nmol/L), whereas during a bicycle ergometer day mean GTN concentration was increased to 3.1 nmol/L (SD +/- 1.7 nmol/L, p less than 0.001). During a sauna day volunteers stayed for 20 minutes in a sauna, and mean GTN concentration in plasma rose to 7.3 nmol/L (SD +/- 1.7 nmol/L, p less than 0.001). Systolic blood pressure increased during exercise (p less than 0.01) but decreased significantly in the sauna (p less than 0.01). Headache was noted frequently (9 of 12 subjects) and dizziness by a few (3 of 12). The demonstrated increased transdermal absorption in our study may infer an increased effect during workload. Whereas the increase in transdermally absorbed GTN may be beneficial to the exercising angina patient, increased effects of GTN may be undesirable in hot surroundings. A study on angina patients is justified to assess whether this phenomenon bears clinical relevance.

Administration, Topical↗
PubMed1989

Preoperative transdermal hyoscine for the prevention of postoperative nausea and vomiting.

In a randomised, double-blind study, a transdermal patch containing either hyoscine or placebo was applied post-auricularly in 190 adult patients under 65 year old, seven to twelve hours prior to their undergoing minor orthopaedic or plastic surgery under thiopentone/nitrous oxide/halothane general anaesthesia. In the first 24 hours after surgery 34% of patients vomited. The incidence of nausea (31% vs 54%; P less than 0.01) and the number of episodes of vomiting (66 vs 125; P less than 0.05) during the first 24 hours were significantly less with hyoscine than with placebo. The hyoscine group required fewer doses of antiemetic than the placebo group (12 vs 27; P less than 0.05). Side-effects were mild, the only difference between the two groups being the frequency of dry mouth immediately preoperatively. No differences were seen in the second 24 hours after surgery. We conclude that transdermal hyoscine is moderately effective in reducing the occurrence of postoperative nausea and vomiting following minor surgery.

Administration, Cutaneous↗
PubMed2003

A controlled trial of rotigotine monotherapy in early Parkinson's disease.

BACKGROUND: Oral dopamine agonists are effective for treating early Parkinson's disease (PD). Rotigotine is a dopamine agonist delivered through a silicone-based transdermal patch that is replaced every 24 hours. OBJECTIVES: To assess the efficacy and safety of rotigotine in patients with PD not receiving dopaminergic medications. DESIGN: Randomized, double-blind, placebo-controlled study. Patients Two hundred forty-two patients with early PD. Intervention Treatment with patches containing either 4.5, 9.0, 13.5, or 18.0 mg of rotigotine or placebo for 11 weeks. Main Outcome Measure The change in the sum of the scores of the activities of daily living and motor components of the Unified Parkinson's Disease Rating Scale from baseline to the end of treatment. RESULTS: There was a significant dose-related improvement in the motor and activities of daily living Unified Parkinson's Disease Rating Scale score between baseline and week 11 for the 13.5- and 18.0-mg groups compared with placebo (placebo, 0.3 +/- 7.7; 13.5-mg group, 5.1 +/- 7.0, P =.001; 18.0-mg group, 5.3 +/- 7.0, P<.001). Adverse experiences that occurred more commonly among subjects randomized to active treatment vs placebo included nausea, application site reactions, dizziness, insomnia, somnolence, vomiting, and fatigue. CONCLUSIONS: Rotigotine can be safely administered once daily transdermally and improves parkinsonian signs in patients with early PD.

Activities of Daily Living↗
PubMed2007

Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease.

OBJECTIVE: This multicenter, randomized, double-blind study was performed to compare the safety and efficacy of the once-daily dopamine agonist rotigotine, in a continuous-dosing transdermal-patch formulation, vs placebo in patients with early-stage Parkinson disease (PD). METHODS: Patients were randomized to receive placebo (n = 96) or rotigotine (n = 181), starting at 2 mg/24 h (10-cm(2) patch size; 4.5-mg total drug content), titrated weekly up to 6 mg/24 h (30-cm(2) patch size; 13.5-mg total drug content), and then maintained for 6 months. The primary efficacy measures were 1) the change in the Unified Parkinson's Disease Rating Scale (UPDRS) scores (parts II and III) from baseline to end of treatment and 2) responder rates (patients with > or =20% improvement). RESULTS: Patients receiving rotigotine had a mean absolute difference of 5.28 (+/-1.18) points lower in UPDRS subtotal scores compared with those receiving placebo (p < 0.0001). The mean change in part III motor scores was -3.50 (+/-7.26) (n = 177) and was the greatest contributor to UPDRS improvement. The rotigotine group had more responders (48 vs 19%; p < 0.0001). The most commonly reported adverse events were application site reactions (44% rotigotine vs 12% placebo), nausea (41 vs17%), somnolence (33 vs 20%), and dizziness (19 vs 13%), and most were mild or moderate in intensity. CONCLUSIONS: Transdermal rotigotine, when titrated to a dosage of 6 mg/24 h, was effective for the treatment of early-stage Parkinson disease in this trial. Adverse events were similar to those found with other transdermal systems and dopamine agonists.

Administration, Cutaneous↗
PubMed2001

Efficacy of estradiol for the treatment of depressive disorders in perimenopausal women: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Results of previous studies suggest that estrogen improves somatic and mild depressive symptoms experienced by perimenopausal women. This study investigated the efficacy of 17beta-estradiol for the treatment of clinically significant depressive disorders in endocrinologically confirmed perimenopausal women. METHODS: Perimenopausal women (aged 40-55 years, with irregular menstrual periods and serum concentrations of follicle-stimulating hormone >25 IU/L), meeting criteria for major depressive disorder, dysthymic disorder, or minor depressive disorder, according to DSM-IV, were randomized to receive transdermal patches of 17beta-estradiol (100 microgram) or placebo in a 12-week, double-blind, placebo-controlled study. A 4-week washout period followed the 12-week treatment phase. Outcome measures were the Montgomery-Asberg Depression Rating Scale and Blatt-Kupperman Menopausal Index scores. RESULTS: Fifty women were enrolled in the study; 26 met DSM-IV criteria for major depressive disorder, 11 for dysthymic disorder, and 13 for minor depressive disorder. Remission of depression was observed in 17 (68%) women treated with 17beta-estradiol compared with 5 (20%) in the placebo group (P =.001). Subjects responded similarly to estradiol treatment, regardless of DSM-IV diagnosis. Patients treated with estradiol sustained antidepressant benefit of treatment after the 4-week washout period, although somatic complaints increased in frequency and intensity. Treatment was well tolerated and adverse events were rare in both groups. CONCLUSION: Transdermal estradiol replacement is an effective treatment of depression for perimenopausal women.

Administration, Cutaneous↗
PubMedDate not supplied

Continuous administration of fentanyl for postoperative pain: a comparison of the epidural, intravenous, and transdermal routes.

STUDY OBJECTIVES: To evaluate the influence of the route of administration [epidural, intravenous (IV), or transdermal] on onset and quality of analgesia and to evaluate the pharmacokinetics of continuous administration of fentanyl. DESIGN: Randomized, open, single-dose, prospective study. SETTING: Postanesthesia care unit of a university hospital. PATIENTS: 54 ASA physical status I-III patients scheduled for lower major abdominal, gynecologic, or urologic surgery. INTERVENTIONS: Patients were assigned to 1 of 3 comparable groups, to receive, for 72 hours postoperatively, an IV (Group IV) or epidural (Group EP) constant-rate infusion of fentanyl (loading dose 1.5 micrograms/kg, infusion rate 1 micrograms/kg/hr), or a transdermal patch (Group TTS), applied preoperatively, delivering fentanyl 75 micrograms/hr. MEASUREMENTS AND MAIN RESULTS: Pain intensity, vital signs, blood gas status, and plasma fentanyl concentration (Cp) were measured for up to 96 hours postoperatively. Onset of analgesia was delayed in Group TTS. Analgesic efficacy was similar for all 3 routes of administration except during the first 4 hours in Group TTS. Initially, the patients in Groups TTS and IV needed significantly more rescue morphine than those in Group EP. The time course for fentanyl Cp in Groups TTS and IV evolved to similar plateau levels. However, fentanyl Cp continued to rise throughout the study period in Group EP, reaching concentrations that elicited hypoxemia after 48 hours. A significant negative relationship existed between fentanyl Cp and oxygen saturation in this group. All 3 routes of administration showed similar frequencies of side effects (i.e., nausea, vomiting, pruritus, and ileus). CONCLUSIONS: The epidural, transdermal, and IV administration of identical doses of fentanyl given at a constant rate provided almost equivalent degrees of analgesia. But continuing epidural administration produced a steady rise in systemic fentanyl concentrations into the ventilatory-depressant range, affecting the hypoxemic regulation of breathing.

Administration, Cutaneous↗
PubMed1998

Novel pharmacokinetic modelling of transdermal nitroglycerin.

PURPOSE: To construct a pharmacokinetic (PK) model and to determine population PK parameters of nitroglycerin (GTN), 1,2-dinitroglycerin (1,2-GDN), and 1,3-dinitroglycerin (1,3-GDN). METHODS: Data were obtained in thirty healthy volunteers following a single dose of a GTN reservoir transdermal patch. Blood samples were obtained just before and at 0.5, 1, 2, 3, 4, 6, 8, 12, 14, and 24 hours after the patch application and 1 hour after its removal. GTN, 1,2-GDN, and 1,3-GDN concentrations were determined using HPLC and simultaneously best fitted using a first-pass mixed-order release one-compartment PK model. Individual estimates (ADAPT-II) were used as priors for a population PK analysis (IT2S). Fitted parameters included the percentage (A) of the nitroglycerin dose reaching the systemic circulation that was released from the patch by a first-order process (K1); two absorption (ka1 and ka2), two metabolite formation (kf1 and kf2) and one metabolite elimination (k(m)) rate constants; and three volumes of distribution Vc/F, V2/F and V3/F. RESULTS: Nitroglycerin mean population parameter estimates and inter-individual variability (CV%) were: A 35% (65), K1 0.06 h-1(91), ka1 5 h-1(46), ka2 0.47 h-1(39), kf1 11 h-1(42), kf2 0.6 h-1(34), k(m) 1.4 h-1(29), V0/F 6 L(31), V2/F 73 L(34), and V3/F 23 L(29). The average elimination half-lives for GTN and the two metabolites were 5 and 32 minutes, respectively. CONCLUSIONS: The proposed PK model fitted observed concentrations of GTN, 1,2-GDN and 1,3-GDN very well. This model should be useful to predict drug and metabolite concentrations and to assess bioequivalence of two transdermal formulations.

Administration, Cutaneous↗
PubMed2006

Effects of pretreatment of needle puncture and sandpaper abrasion on the in vitro skin permeation of fluorescein isothiocyanate (FITC)-dextran.

Microneedle systems have gained attention as having many advantages over transdermal patches and hypodermic needles. The procedure provides adequate skin permeation rates without pain or severe infection. To obtain information for designing a microneedle system, macroneedles were used instead of microneedles to investigate the effects of pretreatment of needle puncture in the skin barrier stratum corneum on in vitro skin permeation of fluorescein isothiocyanate (FITC)-dextrans (4.3, 9.6 and 42.0 kDa) (FD-4, FD-10 and FD-40). The effect of sandpaper abrasion was also investigated for comparison. Both pretreatments on the skin barrier significantly increased the skin permeation of FDs. Lactate dehydrogenase (LDH) leaching was measured after pretreatment of macroneedle and sandpaper abrasion on the skin to evaluate the skin damage by these pretreatment methods. Lower leaching of LDH was observed after macroneedle puncture than after sandpaper abrasion. Next, a parallel permeation-resistance model of the skin barrier was established. Skin permeation of FD-10 was predicted by the model as a function of the number of pores in the skin barrier. Our results suggest that needle puncture may provide a safe, efficient and controllable alternative for increasing transdermal drug delivery.

Administration, Cutaneous↗
PubMed2006

Effects of ultra-low-dose transdermal estradiol on cognition and health-related quality of life.

BACKGROUND: Several small trials and many observational studies suggest that estrogen treatment in postmenopausal women improves cognition, but 2 large randomized trials have shown harm. The effect of an ultra-low- dose of unopposed transdermal estradiol on cognition and health-related quality of life is unknown. OBJECTIVE: To investigate the effect of unopposed ultra-low-dose transdermal estradiol on cognitive function and quality of life in postmenopausal women. DESIGN: Randomized, placebo-controlled, double-blind trial with 2-year follow-up. The main outcome of the trial was change in bone density. Changes in cognitive function and quality of life were preplanned secondary outcomes of the trial. SETTING: Nine clinical centers in the United States. PARTICIPANTS: Postmenopausal women (N = 417), aged 60 to 80 years, with a normal bone density for age and an intact uterus. INTERVENTION: A weekly transdermal patch that delivers estradiol, 0.014 mg/d (n = 208), or placebo (n = 209). MAIN OUTCOME MEASURES: Seven standardized cognitive tests (a total of 10 scores) administered at baseline and years 1 and 2 to test global cognitive function, verbal and visuospatial memory, language, executive function, and semantic memory. The 36-Item Short-Form General Health Survey was administered to assess health-related quality of life in physical and mental domains. The sample size provided 80% power to detect a standardized effect of 0.29 SD, a small-to-moderate difference. RESULTS: Baseline characteristics were similar in the 2 treatment groups. At 2 years of follow-up, we found no statistically significant differences between treatment groups in change on any of the cognitive test scores or on the 36-Item Short-Form General Health Survey (P > .12 for all). There was no consistent evidence that the effect of treatment on change in cognitive or 36-Item Short-Form General Health Survey scores depended on the level of baseline endogenous estradiol. CONCLUSION: Postmenopausal treatment with ultra-low-dose unopposed transdermal estradiol for 2 years had no effect on change in cognitive function or in health-related quality of life over 2 years of treatment.

Administration, Cutaneous↗
PubMed1997

The metabolic consequences of treating postmenopausal women with non-oral hormone replacement therapy.

OBJECTIVE: To define the metabolic profile of postmenopausal hormone replacement therapies when delivered through gels, patches, implants or other non-oral routes. Such information may be useful in the absence of reliable clinical data on the effects of these therapies on the risk of cardiovascular disease. DESIGN AND METHODS: Selective literature review. PATIENTS: Postmenopausal women. RESULTS: Non-oral oestrogen therapies fail to invoke the hepatic response associated with oral therapy. Changes in hepatic protein synthesis are minimal and so plasma levels of binding globulins and other proteins tend to be normal. Many of the perturbations of the haemostatic system seen with oral therapy are avoided. In the absence of hepatic over-synthesis of apolipoproteins, plasma lipoprotein levels are unchanged or reduced. The direct effects of oestrogen on vascular function are apparent when the hormone is administered non-orally. CONCLUSIONS: The net effect of non-oral estrogen therapies on the risk of cardiovascular disease is difficult to predict on the basis of current data. Some changes in plasma lipoprotein levels, such as the reduced fasting levels of triglycerides, would be considered desirable, but the cardioprotective increase in levels of high-density lipoproteins is absent. The differential effect on haemostasis markers is promising, but preliminary data relating to transdermal patches fail to support the idea that non-oral therapies will avoid the increased risk of venous thromboembolism associated with oral therapy. The ability of non-oral therapies to improve vascular function implies that they will offer postmenopausal women at least some of the cardiovascular protection seen with oral therapy.

Administration, Oral↗
PubMed2002

MethyPatch Noven.

Noven Pharmaceuticals is developing a transdermal patch formulation of methylphenidate for the treatment of attention deficit hyperactivity disorder (ADHD) [325808]. Phase III trials were completed in February 2002 [438893]; at this time, the company predicted a 2003 launch for the product [441478]. In April 2002, based on pivotal phase III trial results, Noven expected to file an NDA with the FDA in mid-2002 and to launch the product in the second half of 2003 [445181]. In June 2002, the NDA was filed [456552]. The original phase III trials were completed in the first quarter of 2001 [407254]. However, preliminary analysis of the phase III trial, reported in April 2001, suggested that a supplemental study would be required to support the filing [403771]. At this time, an NDA filing, originally planned for the second quarter of 2001, was rescheduled for the first half of 2002 [400122], [407640], [410285], [441478]. As of August 2001, the supplemental study was expected to begin in autumn of that year [417877]. In October 2001, enrolment was initiated in Noven's pivotal, double-blind, placebo-controlled, multicenter phase III study of MethyPatch [427321], and it was completed in February 2002 [438893]. In May 2001, the company was issued patent US-06210705 relating to the transdermal delivery of methylphenidate for the treatment of ADHD [410285]. In June 2001, ABN AMRO predicted sales of US $61 million in 2002, rising to US $74 million in 2005 [422762]. Analysts at Morgan Stanley predicted in May 2002 that the product would make US sales of US $9.1 million in 2003, rising to US $22.5 million in 2006 [454573].

Administration, Cutaneous↗
PubMed2003

Medical oophorectomy with and without estrogen add-back therapy in the prevention of migraine headache.

OBJECTIVES: To determine the preventive benefit of "medical oophorectomy" and transdermal estradiol in women with migraine. BACKGROUND: Epidemiological studies have demonstrated that declines in serum estrogen levels occurring during normal menstrual cycles can trigger headache in women with migraine. Prior to this study, no randomized controlled trials have evaluated whether minimizing these hormonal changes pharmacologically can prevent headache. METHODS: Twenty-one women with regular menstrual cycles and a diagnosis of migraine headache were enrolled. After a 2.5-month placebo run-in phase, all patients received a subcutaneous goserelin implant (a gonadotropin-releasing hormone agonist) to induce a medical oophorectomy. One month later, while continuing goserelin, participants were randomized to receive a transdermal patch containing 100 microg of estradiol-17beta (gonadotropin-releasing hormone agonist/estradiol group, n = 9) or a placebo patch (gonadotropin-releasing hormone agonist/placebo group, n = 12) during a 2-month treatment phase. The primary outcome measure was the headache index, which was defined as the mean of pain severity ratings (0 to 10 scale) recorded three times per day by daily diary. Secondary outcome measures included headache disability, headache severity, headache frequency, and the percentage of headaches with a pain severity rating of 7 or greater. RESULTS: The headache index was significantly lower during the treatment period in the gonadotropin-releasing hormone agonist/estradiol group than in the gonadotropin-releasing hormone agonist/placebo group (P =.025). Similar improvements were observed in the gonadotropin-releasing hormone agonist/estradiol group for all secondary outcome measures with the exception of headache frequency, which was unchanged between the groups. Within the gonadotropin-releasing hormone agonist/estradiol group, there was a 33.7% reduction (95% confidence interval, -64.4 to -3.0) in the headache index during the treatment phase when compared with the placebo run-in phase; no difference was seen between those phases within the gonadotropin-releasing hormone agonist/placebo group. CONCLUSIONS: Minimization of hormonal fluctuations with gonadotropin-releasing hormone agonist therapy alone is inadequate to prevent headache in women who are premenopausal with migraine. The addition of transdermal estradiol to existing gonadotropin-releasing hormone agonist therapy provides a modest preventive benefit.

Administration, Cutaneous↗
PubMedDate not supplied

Combined hormone therapy in postmenopausal women with features of metabolic syndrome. Results from a population-based study of Swedish women: Women's Health in the Lund Area study.

OBJECTIVE: To delineate the influence of hormone therapy (HT) on features of metabolic syndrome with special reference to the composition and mode of administration of three specific HT regimens, all containing estradiol (E2) + norethisterone. DESIGN: The Women's Health in the Lund Area project screened all women (n = 10,766), born between 1935 and 1945. Complete data were obtained from 6,917 women. Those at or above defined cutoff limits were considered positively screened (n = 3,593) for metabolic syndrome. All of them were invited to undergo an oral glucose tolerance test; 2,923 women accepted. After excluding 200 women with impaired fasting glucose, 2,723 women were included in the present analysis. Serum lipids were determined by conventional standard methods at the department of clinical chemistry of Lund University Hospital. RESULTS: According to World Health Organization criteria, 2,123 women had normal glucose tolerance and 600 women had impaired glucose tolerance (IGT). IGT was less common (P = 0.001) among users of a transdermal patch [CYC-TRANS; E2 50 microg + norethisterone acetate (NETA) 250microg] compared with the two-combined oral regimen [CON-O (continuous oral E2 2 mg + NETA 1 mg) + CYC-O (sequential oral E2 2 mg + NETA 1 mg)]. Furthermore, IGT was more common among CON-O users when compared with either the CYC-O + CYC-TRANS group (P = 0.002) or the CYC-TRANS only group (P = 0.001). There were no significant differences between CYC-O versus CYC-TRANS or CON-O. Serum levels of total cholesterol were higher in the CYC-TRANS group than in the combined CON-O + CYC-O group (P < 0.05); they also were higher (P = 0.05) when comparing the CYC-O + CYC-TRANS versus CON-O as well as higher in CYC-TRANS versus CON-O (P < 0.05). Serum high-density lipoprotein cholesterol levels were higher in the CYC-O (P = 0.001), CYC-TRANS (P < 0.05), and the CYC-O + CYC-TRANS (P = 0.001) groups when compared with the CON-O users. There were no differences in the mean age, blood pressure (systolic and diastolic), body mass index, waste-hip ratio, or the rate of cigarette and alcohol consumption between the different hormone regimens. CONCLUSION: The risk of having a pathological glucose load was lower in transdermal versus oral users of HT. Transdermal HT could be regarded as first-line treatment in women at risk of developing diabetes.

Aged↗
PubMed2002

Efficacy and tolerability of low-dose transdermal estrogen (Oesclim) in the treatment of menopausal symptoms.

OBJECTIVE: To establish the proportion of symptomatic postmenopausal women who can be satisfactorily maintained on a low HRT dose of 25 microg/day 17-beta-estradiol (Oesclim 25 transdermal patches), after 8 weeks of treatment. STUDY DESIGN AND PATIENTS: This was a multicenter open label non-comparative trial. Treatment was initiated with 25 microg/day dosage, which could be increased to 50pg/day if required after 8 weeks, according to clinical evaluation. Sequential treatment with an oral progestogen was also given for > or = 12 days/month in all non-hysterectomized women. The primary criterion for evaluation of efficacy was the proportion of patients who remained on Oesclim 25 after 8 weeks of treatment in comparison to patients requiring Oesclim 50. RESULTS: Sixty-two patients were included in the study and 60 were treated. 88.3% of treated patients [CI: 78.7-94.9] fulfilled the primary criterion, remaining with the Oesclim 25 dosage after 8 weeks of treatment. All clinical menopausal symptoms showed a decrease from baseline to the end of the study. The mean daily number of vasomotor symptoms decreased from 8.2 (+/- 5.6) at baseline, for the entire treated population, to 1.0 (+/- 2.2) and 1.0 (+/- 1.2) at the end of the study in patients remaining with Oesclim 25 and in those requiring Oesclim 50, respectively. At the interim visit, patients in the Oesclim 50 group had a higher number of symptoms than those maintained on Oesclim 25. The global efficacy of the treatment was evaluated as very effective/effective by 93% of all patients and very good/good by investigators for 91% of their patients. Overall 91% of all patients evaluated the global tolerability as very well/well, while investigators rated it very good/good for 97% of their patients. The vast majority of all patients (93%) were very satisfied/satisfied with the trial treatment, and 90% of them were willing to continue the study drug. CONCLUSION: Oesclim low dose (25microg) hormonal transdermal therapy was efficient in management of climacteric symptoms in this 16-week study. The good acceptance of the treatment was associated with its high efficiency and tolerability.

Administration, Cutaneous↗
PubMed2001

A novel male contraceptive pill-patch combination: oral desogestrel and transdermal testosterone in the suppression of spermatogenesis in normal men.

This study investigated the effect of transdermal T and oral desogestrel on the reproductive axis of healthy men. Twenty-three men were randomized to 1 of 3 treatment groups and received a daily transdermal T patch plus oral desogestrel at a dose of 75, 150, or 300 microg/d for 24 wk. Baseline blood and semen samples were obtained and then every 4 wk thereafter for 32 wk. The outcome measures were sperm density and plasma levels of FSH, LH, total and free T. The results show a dose-dependent suppression of spermatogenesis and gonadotropins. Seven of the 17 subjects became azoospermic. Desogestrel (300 microg daily) in combination with 5 mg daily transdermal T was the most effective (57% azoospermic), whereas a dose of 75 microg was ineffective (0% azoospermic). Total and free plasma T were reduced by approximately 30%. High density lipoprotein cholesterol was significantly reduced. No serious side-effects were encountered. We conclude that daily self-administered desogestrel with transdermal T is capable of suppressing the male reproductive axis, although the efficacy was less marked and less consistent than injectable regimens. The lower efficacy is likely to be due to failure of the transdermal T system to maintain circulating T levels consistently in the required range.

Administration, Cutaneous↗
PubMedDate not supplied

Current status of testosterone replacement therapy in men.

Testosterone plays an essential role in the development of the normal male and in the maintenance of many male characteristics, including muscle mass and strength, bone mass, libido, potency, and spermatogenesis. Androgen deficiency occurs with disorders that damage the testes, including traumatic or surgical castration (primary testicular failure) or disorders in which the gonadotropin stimulation of the testes is reduced (hypogonadotropic hypogonadism). The clinical manifestations of androgen deficiency depend on the age at onset and the severity and duration of the deficiency. In adult males, these manifestations may include reduced body hair, decreased muscle mass and strength, increased fat mass, decreased hematocrit, decreased libido, erectile dysfunction, infertility, osteoporosis, and depressed mood. The forms of androgen replacement currently available in the United States are intramuscular depot injections of testosterone esters, oral tablets of testosterone derivatives, and transdermal patches. For most patients, androgen replacement therapy with testosterone is a safe, effective treatment for testosterone deficiency.

Adult↗