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PubMed1995

The safety, tolerability and efficacy of transdermal nicotine (Nicotinell TTS) in initially hospitalised patients.

AIM: We studied a transdermal nicotine system with minimal behavioural intervention in hospitalised patients to assess patient acceptability, safety and efficacy. METHOD: In an open noncomparative study, 80 smoking patients (42 men and 38 women) were enrolled. They received 24-hour nicotine patches and simple support for 12 weeks and were followed for up to 26 weeks. Smoking was assessed by interview, expired air carbon monoxide and blood cotinine. RESULTS: Side effects included itch and local erythema (4), insomnia (7), abnormal taste (3). Two subjects withdrew from the study because of side effects. At 12 weeks 17 were nonsmokers. At 26 weeks 19 of 80 were nonsmokers and a further 14 had reduced their intake significantly. CONCLUSIONS: The nicotine skin patch proved to be safe and well tolerated. Efficacy was comparable to controlled trials of transdermal nicotine patches.

Administration, Cutaneous↗
PubMed2002

An evaluation of bioequivalence of two 7-day 17beta-estradiol transdermal delivery systems by anatomical site.

An open-label, randomized, crossover study was conducted to assess the bioequivalence of two 7-day transdermal 17beta-estradiol delivery systems following application to the buttock in 42 postmenopausal women. The systems tested were a generic Estradiol Transdermal System (Mylan Pharmaceuticals, Inc.) and Climara (Berlex Laboratories, Inc.), the reference product. Each system was labeled to deliver 17beta-estradiol 0.1 mg/day and was applied for 7 days. Serial serum samples were assayed for estradiol, estrone, and estrone sulfate using validated assays. The bioequivalence confidence intervals for the ratio of log-transformed 17beta-estradiol Cmax values for the Estradiol Transdermal System and Climara were outside the interval of 0.80 to 1.25, indicating that the products were not bioequivalent. Application site reactions and skin irritation were more common with the Estradiol Transdermal System than with Climara. The odds of patch lifting or detachment were 6.95 times higher with the Estradiol Transdermal System than with Climara. Because these two transdermal delivery systems had been previously shown to be bioequivalent after application to the abdomen, the findings of this study suggest that bioequivalence at one anatomical site is not indicative of bioequivalence at another.

Administration, Cutaneous↗
PubMed2001

Transdermal dopaminergic D(2) receptor agonist therapy in Parkinson's disease with N-0923 TDS: a double-blind, placebo-controlled study.

N-0923 is a non-ergot, dopaminergic D(2) agonist designed to be transdermally available. It has anti-parkinsonian effects when infused intravenously. An adhesive matrix patch was developed to deliver N-0923 transdermally (N-0923 TDS). In this phase II trial, we evaluated the effectiveness of various doses of N-0923 TDS at replacing levodopa. Eighty-five Parkinson's disease (PD) patients were randomized to placebo or one of four doses of N-0923 TDS for 21 days. Change in daily levodopa dose was the primary efficacy measure. Significantly greater reductions in levodopa dose were achieved as compared to placebo for the two highest doses of N-0923 TDS. Patients treated with 33.5 mg and 67 mg N-0923 TDS decreased levodopa use by 26% and 28%, vs. 7% for placebo. N-0923 TDS was safe and well tolerated.

Administration, Cutaneous↗
PubMed2005

Transdermal delivery of human growth hormone through RF-microchannels.

PURPOSE: To evaluate the bioavailability and bioactivity of human growth hormone (hGH) delivered transdermally through microchannels (MCs) in the skin created by radio-frequency (RF) ablation. METHODS: The creation of MCs was observed in magnified rat and guinea pig skin after staining by methylene blue. Various doses of hGH in a dry form were applied on rat or guinea pig (GP) skin after the formation of MCs. The pharmacokinetic profile of systemic hGH in both animal models was monitored for 15 h post patch application. Bioactivity of the transdermally delivered hGH was verified by measuring IGF-I levels in hypophysectomized rats. RESULTS: The ordered array of MCs was clearly visible in the magnified rat and guinea pig skin. The MCs were very uniform in diameter and of equal separation. Creation of MCs in the outer layers of the skin enabled efficient delivery of hGH, with a bioavailability of 75% (rats) or 33% (GPs) relative to subcutaneous (s.c.) injection with plasma profiles resembling that of s.c. injection. Elevated levels of systemic insulin-like growth factor-1 (IGF-I) were observed after transdermal delivery of hGH to hypophysectomized rats indicative of the bioactivity of the transdermally delivered hGH in vivo. CONCLUSIONS: Formation of RF-microchannels is a well-controlled process. These MCs permitted the transdermal delivery of bioactive hGH in rats and GPs with high bioavailability.

Administration, Cutaneous↗
PubMed1993

One year efficacy and tolerability of clonidine administered by the transdermal route in patients with mild to moderate essential hypertension--a multicentre open label study. The Antihypertensive Patch Italian Study (APIS) Investigators.

The clonidine patch offers for the first time the unique possibility of a once-a-week transdermal therapy of hypertension due to direct absorption of clonidine through the skin. The present study investigates the efficacy and safety of the transdermal administration on a sample of the Italian population. 101 patients entered the study, 51 male, 50 female (mean age: 53 years, SD +/- 10; range: 30-71 years), they were given clonidine by a therapeutical transdermal system as starting dosage. If blood pressure was not adequately controlled (DBP < 90 or 10 mmHg decreased from baseline value) the dosage was increased on a 2 week basis assessment. The patients were then followed for 12 months after the start of treatment. The decrease in both systolic and diastolic blood pressure continued up to one month after start of treatment and remained constant for at least 9 months. A total of 70% of the patients were controlled by the antihypertensive treatment as monotherapy, while in 6% additional combination with a diuretic lead to blood pressure control. 5% of the patients showed no reduction in blood pressure at the end of the titration phase. 24 (23%) patients complained of skin reaction; 21 patients of these (ten male, eleven female) were withdrawn from the trial due to predefined skin reaction criteria. No serious side effects have been observed during the run of the study. No rebound phenomena occurred in the week after treatment discontinuation. It is concluded that the transdermal treatment of hypertension with a clonidine containing transdermal system is therapeutically effective and probably associated with a high acceptability and increased compliance.

Administration, Cutaneous↗
PubMedDate not supplied

A decade of experience with transdermal estrogen replacement therapy: overview of key pharmacologic and clinical findings.

Although estrogen replacement therapy (ERT) has proven highly effective in preventing both the short- and long-term adverse clinical outcomes associated with menopause, it is important to recognize that the pharmacokinetic and metabolic effects of ERT vary with dosage and route of delivery. One of the most promising methods of administering ERT is the transdermal therapeutic system (TTS), or "patch," the efficacy of which is comparable to that of other forms of ERT, but whose unique pharmacokinetic profile may confer several distinct clinical advantages over the oral route. The present article addresses some of the key pharmacokinetic and metabolic differences between these two dosing forms, with particular emphasis on their respective effects on gonadotropins, hemostasis and coagulation, lipid metabolism, hepatobiliary function, and bone. An extensive review of clinical experience accrued over the past decade suggests that transdermal ERT is a viable alternative to oral ERT.

Administration, Cutaneous↗
PubMed1995

Transdermal fentanyl: a new step on the therapeutic ladder.

The high efficacy, low molecular weight and high lipid solubility of fentanyl make it a suitable agent for transdermal administration. Effective plasma concentrations are maintained for up to 48-72 hours after application of a transdermal therapeutic system (TTS) fentanyl patch. In a multicentre study, slow-release morphine was replaced by TTS fentanyl according to a special calculation table (10 mg oral morphine corresponding to approximately 0.1 mg TTS fentanyl). Ninety-eight patients were included in the study. Due to protocol infringements, however, the switch from oral morphine to TTS fentanyl could be assessed for only 38 patients. The changeover at a ratio of 100:1 proved to be safe and effective and a good alternative therapy to conventional strong opioids. The majority of the patients wished to continue TTS fentanyl therapy at the end of the study period. Side effects were similar to those associated with other opioids. However, TTS fentanyl was associated with a distinct decrease in constipation and a significant reduction in the use of laxatives. Furthermore, there were some indications that compliance may be increased with TTS fentanyl. Special indications for chronic pain therapy using transdermal opioids include head and neck and gastro-intestinal tract cancer. In these cases, TTS fentanyl may be the final non-invasive form of analgesic therapy which allows the patient to maintain a normal lifestyle. TTS fentanyl thus represents a new alternative for therapy with strong opioids on step III of the World Health Organization analgesic ladder.

Administration, Cutaneous↗
PubMed2001

The effect of transdermal glyceryl trinitrate, a nitric oxide donor, on blood pressure and platelet function in acute stroke.

BACKGROUND AND PURPOSE: Hypertension is a common medical complication in acute stroke and is associated with a poor outcome. However, no large trials have assessed the effect of lowering blood pressure (BP) on outcome, and it remains unclear how BP should be managed in acute stroke. We assessed, in a double-blind randomised controlled trial, whether the nitric oxide (NO) donor glyceryl trinitrate (GTN, a known systemic and cerebral vasodilator), would lower BP and alter platelet function. METHODS: Thirty-seven patients with recent (< 5 days) ischaemic or haemorrhagic stroke were randomised by minimisation to 12 days of daily treatment with transdermal GTN or matching placebo patches. Twenty-four-hour ambulatory BP was measured before and during GTN treatment at days 0, 1 and 8. Platelet aggregation and expression of adhesion molecules were assessed at the same time points. Functional outcome (Rankin scale) and case fatality were assessed at 3 months. Analysis was by intention-to-treat. RESULTS: GTN significantly lowered BP by 13.0/5.2 mm Hg at day 1 and 9.3/5.0 mm Hg at day 8. The lesser reduction at day 8 than day 1 suggests that tolerance to GTN was developing. Non-significant falls of 0.9/0.6 and 3.8/0.0 mm Hg occurred at days 1 and 8, respectively, in the placebo group. GTN had no effect on heart rate, or platelet aggregation or expression of platelet adhesion molecules, including glycoproteins Ia, Ib, IIIa and P-selectin. Additionally, GTN did not alter case fatality or dependency, although the study was not powered for these outcomes. CONCLUSIONS: Transdermal GTN, an NO donor, lowered BP by 5-8%, a clinically significant and relevant, but not excessive, degree in patients with acute stroke. However, GTN had no effect on platelet aggregation or expression of adhesion molecules. Since NO donors increase cerebral blood flow in patients with acute ischaemic stroke, GTN may be an appropriate drug for testing the effect of lowering BP on functional outcome.

Administration, Cutaneous↗
PubMedDate not supplied

Permeation enhancers compatible with transdermal drug delivery systems. Part I: selection and formulation considerations.

Part I of this article reviews the classification, chemistry, properties, selection, and use of skin permeation enhancers in transdermal drug delivery systems and dermal patches. The authors discuss ideal properties of enhancers and describe various enhancers' actions on the skin. Part II will describe interactions between permeation enhancers and other transdermal delivery system components, such as backing materials, pressure-sensitive adhesives, membranes, and release liners. Adhesive properties critical to the optimization of a transdermal formulation will be discussed.

Adjuvants, Pharmaceutic↗
PubMed1992

Transdermal clonidine as an adjunct to enalapril: an evaluation of efficacy and patient compliance.

This four-center, 20-week, open-label study evaluated transdermal clonidine as an adjunct to enalapril 10 mg daily and demonstrated patterns of compliance. Seventy-four mildly to moderately hypertensive patients (mean seated blood pressure, 150/101 mm Hg) received enalapril 10 mg once daily as initial monotherapy. In 66 patients, the seated diastolic blood pressure remained greater than or equal to 90 mm Hg at the trough blood levels of enalapril. Transdermal clonidine (3.5 cm2, 7.0 cm2, or 10.5 cm2, equivalent to 0.1 mg, 0.2 mg, and 0.3 mg clonidine/day, respectively) then was added as needed to achieve blood pressure control. Forty-eight patients achieved diastolic blood pressures less than 90 mm Hg on concomitant therapy; 44 patients completed 8 weeks of maintenance dosing with a mean blood pressure of 134/85 mm Hg. Oral compliance, as measured by an electronic device that was actuated each time the medication vial was opened, varied from 48 to 140%. Compliance with the transdermal clonidine regimen was excellent; the patch was worn as directed during 96% of the patient-weeks of therapy. The authors conclude that blood pressure can be controlled by a combination of transdermal clonidine and enalapril in patients that do not adequately respond to enalapril monotherapy. Patients poorly complying with oral regimens may be candidates for a trial of transdermal clonidine monotherapy.

Administration, Cutaneous↗
PubMed2001

Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels.

BACKGROUND: A large proportion of men over 65 years of age have bioavailable testosterone levels below the reference range of young adult men. The impact of this on musculoskeletal health and the potential for improvement in function in this group with testosterone supplementation require investigation. METHODS: Sixty-seven men (mean age 76 +/- 4 years, range 65--87) with bioavailable testosterone levels below 4.44 nmol/l (lower limit for adult normal range) were randomized to receive transdermal testosterone (two 2.5-mg patches per day) or placebo patches for 1 year. All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones (testosterone, bioavailable testosterone, sex-hormone binding globulin [SHBG], estradiol, and estrone), bone mineral density (BMD; femoral neck, Ward's triangle, trochanter, lumbar spine, and total body), bone turnover markers, lower extremity muscle strength, percent body fat, lean body mass, hemoglobin, hematocrit, prostate symptoms, and prostate specific antigen (PSA) levels. RESULTS: Twenty-three men (34%) withdrew from the study; 44 men completed the trial. In these men, bioavailable testosterone levels increased from 3.2 +/- 1.2 nmol/l (SD) to 5.6 +/- 3.5 nmol/l (p <.002) at 12 months in the testosterone group, whereas no change occurred in the control group. Although there was no change in estradiol levels in either group, estrone levels increased in the testosterone group (103 +/- 26 pmol/l to 117 +/- 33 pmol/l; p <.017). The testosterone group had a 0.3% gain in femoral neck BMD, whereas the control group lost 1.6% over 12 months (p =.015). No significant changes were seen in markers of bone turnover in either group. Improvements in muscle strength were seen in both groups at 12 months compared with baseline scores. Strength increased 38% (p =.017) in the testosterone group and 27% in the control group (p =.06), with no statistical difference between the groups. In the testosterone group, body fat decreased from 26.3 +/- 5.8% to 24.6 +/- 6.5% (p =.001), and lean body mass increased from 56.2 +/- 5.3 kg to 57.2 +/- 5.1 kg (p =.001), whereas body mass did not change. Men receiving testosterone had an increase in PSA from 2.0 +/- 1.4 microg/l to 2.6 +/- 1.8 microg/l (p =.04), whereas men receiving placebo had an increase in PSA from 1.9 +/- 1.0 microg/l to 2.2 +/- 1.5 microg/l (p =.09). No significant differences between groups were seen in hemoglobin, hematocrit, symptoms or signs of benign prostate hyperplasia, or PSA levels. CONCLUSIONS: Transdermal testosterone (5 mg/d) prevented bone loss at the femoral neck, decreased body fat, and increased lean body mass in a group of healthy men over age 65 with low bioavailable testosterone levels. In addition, both testosterone and placebo groups demonstrated gains in lower extremity muscle strength, possibly due to the beneficial effects of vitamin D. Testosterone did result in a modest increase in PSA levels but resulted in no change in signs or symptoms of prostate hyperplasia.

Administration, Cutaneous↗
PubMed1994

Two studies of the clinical effectiveness of the nicotine patch with different counseling treatments.

OBJECTIVE: To assess the effectiveness of transdermal nicotine therapy for smoking cessation and suppression of withdrawal severity in conjunction with two different adjuvant counseling treatments. DESIGN: Two independent randomized placebo-controlled double-blind trials. SETTING: Smoking cessation clinic. SUBJECTS: Eighty-eight (study 1) and 112 (study 2) adult volunteers motivated to quit smoking. INTERVENTIONS: Eight weeks of 22-mg transdermal nicotine therapy with group counseling (study 1); 4 weeks of 22 mg followed by 2 weeks of 11-mg transdermal nicotine therapy with brief individual counseling (study 2). MAIN OUTCOME MEASURES: Modified point prevalence (7 consecutive days of nonsmoking) at the end of patch treatment and 6 months after treatment initiation was assessed by self-report and biochemically confirmed; survival analyses were also conducted for both studies to compare treatment efficacy. Also, we examined the impact of the nicotine patch on specific withdrawal symptoms (anger, anxiety, awakening, difficulty concentrating, depression, hunger, impatience, and craving). RESULTS: Transdermal nicotine treatment produced higher cessation rates at the end of treatment than did placebo with both adjuvant counseling interventions: 59 percent vs 40 percent (p < 0.05 in study 1) and 37 percent vs 20 percent (p < 0.05 in study 2), respectively. Smoking cessation efficacy was maintained 6 months after initiation of treatment: 34 percent vs 21 percent (p = 0.08 in study 1) and 18 percent vs 7 percent (p = 0.05 in study 2). Survival analyses also revealed significant group differences in efficacy in both studies. Nicotine patches also suppressed a variety of withdrawal symptoms, including craving in the first weeks after patients quit smoking. CONCLUSION: Transdermal nicotine effectively augments smoking cessation rates with two different types of counseling treatment. Overall, the nicotine patch approximately doubles the sustained rate of smoking cessation. Additionally, the nicotine patch provides relief from some tobacco withdrawal symptoms.

Administration, Cutaneous↗
PubMedDate not supplied

Permeation enhancers compatible with transdermal drug delivery systems: part II: system design considerations.

Part I of this article reviewed the classification, chemistry, properties, selection, and use of skin permeation enhancers in transdermal drug delivery systems and dermal patches. In Part II, the authors discuss ideal properties of enhancers and describe various enhancers' actions on the skin, as well as interaction among permeation enhancers and other transdermal delivery system components, such as backing materials, pressure-sensitive adhesives, membranes, and release liners. Adhesive properties critical to the optimization of a transdermal formulation are discussed.

Adjuvants, Pharmaceutic↗
PubMed2006

Regional differences in transdermal penetration of fentanyl through equine skin.

The rate and regional differences for the penetration of fentanyl through equine skin was investigated in vitro using a commercial transdermal therapeutic system (TTS) or 'patch'. Skin collected from the thorax, groin and leg (dorsal metacarpal) regions of five horses was placed in diffusion cells and a fentanyl TTS applied to each skin sample. Drug penetration through each skin sample over 48 h measured using high performance liquid chromatography (HPLC). Cumulative penetration (microg/cm2) was plotted against time (h) and used to regress the steady state flux (microg/cm2/h) of fentanyl through each skin site. Results showed similar fluxes for both the thorax (2.32+/-0.17 microg/cm2/h and groin (2.21+/-0.11 (microg/cm2/h) regions, but significantly lower flux (P=<0.05) for the leg region (1.56+/-0.120 microg/cm2/h. Interestingly, there was a significantly longer lag time for the penetration of fentanyl through the groin region (7.87+/-0.51 h) compared to the other two sites (5.66+/-0.97 h and 5.75+/-0.43 h for the thorax and leg regions respectively). The results suggest that a fentanyl TTS applied to the leg region may have a small but significantly lower amount of fentanyl available systemically, compared to patches applied to the thorax or groin regions, which may affect the level of analgesia subsequently achieved in the horse.

Administration, Cutaneous↗
PubMed2000

Laryngeal cytological aspects in women with surgically induced menopause who were treated with transdermal estrogen replacement therapy.

OBJECTIVE: To investigate the effects of estrogen replacement therapy (ERT) on laryngeal cytology in postmenopausal women. DESIGN: Prospective open clinical trial. SETTING: Outpatient menopausal clinic in the Department of Gynecology, University of Catania, Catania, Italy. PATIENT(S): Eighty-four healthy, surgically postmenopausal women, of whom 48 were treated with ERT and 36 were considered as a control group. INTERVENTION(S): Transdermal E(2) treatment by patches or gel, evaluation of laryngeal cytology with cytobrush by indirect laryngoscopy, and questionnaire for the voice history. MAIN OUTCOME MEASURE(S): Changes in cytologic aspects of laryngeal cells with respect to vaginal cytology by hematoxylin and eosin staining; subjective voice changes. RESULT(S): Sixty-seven women completed the study. Ten women from the ERT group and five from the control group dropped out because of the invasive laryngoscope method; two subjects in the control group were excluded because of pathologies of the vocal cord. Hematoxylin and eosin staining confirmed similar superficial-intermediate aspects of the cells between the laryngeal and the vaginal smears in ERT-treated women. In the control group, both smears showed aspects of atrophy-dystrophy. The ERT group had a subjectively better quality of voice than the control group. CONCLUSION(S): Our study confirms that the larynx is an estrogen target, as are vaginal cells. ERT may provide prevention and treatment of dystrophic pathologies of the vocal cords in postmenopausal women.

Administration, Cutaneous↗
PubMed1985

Influence of transdermal scopolamine on motion sickness during 7 days' exposure to heavy seas.

We conducted a double-blind, placebo-controlled study to evaluate the efficacy and tolerability of transdermal scopolamine in the prevention of motion sickness (MS) aboard a frigate during 7 days of continuously moderate or heavy seas. Forty-nine healthy sailors with a previous history of MS were randomly assigned to receive a transdermal therapeutic system of scopolamine (TTS-S) or transdermal placebo (TD-P). Patches were placed behind the ears at least 4 hours before departure and were removed 72 hours later. Subjects were observed on days 1 to 4 and 6. In the TTS-S group, both subjective feeling of MS and the incidence of nausea were reduced during the first 2 days. Because of adaptation, differences in signs and symptoms of MS between subjects receiving TTS-S and TD-P disappeared after the second day. During the first 3 days, vomiting occurred less often in the TTS-S group. On day 6, 3 days after removal of the patch, vomiting occurred in 23% of the TTS-S group, probably due to delay in adaptation, but none of the subjects in the TD-P group vomited. Concentration was not adversely influenced, since the ability to work increased in the TTS-S group. During prolonged continuous exposure to heavy and moderate seas, 2.5 cm2 TTS-S discs proved to be efficacious in preventing MS, with xerostomia as a tolerable side effect and no significant ocular side effects.

Administration, Topical↗
PubMed2004

The acceptability of a small intrauterine progestogen-releasing system for continuous combined hormone therapy in early postmenopausal women.

OBJECTIVE: To assess the acceptability, ease of insertion, tolerance and associated bleeding of a novel intrauterine progestogen-releasing system, combined with transdermal estradiol, in postmenopausal women. DESIGN: An open non-comparative study of 294 postmenopausal women with an intact uterus at 27 centers in six countries. METHOD: All subjects had requested treatment for menopausal symptoms and had received transdermal estradiol 50 microg/day by patch and an experimental intrauterine system (MLS) releasing levonorgestrel 10 microg/day. Details of the insertion were recorded and subsequent bleeding, side-effects and adverse events were documented on a daily diary. Endometrial thickness was measured by transvaginal ultrasound scan prior to insertion of the MLS and after 12 months. The study is of 3 years duration. This report summarizes the results after the first year. RESULTS: The median age of the subjects was 52.6 years (range 41.7-59.6 years), 90% were within 3-5 years of menopause and 78% had previously used hormone therapy (HT). The MLS was inserted at the first attempt in 297/294 (94%) subjects and was facilitated by dilatation of the cervical canal in 65 (22%) subjects. Local anesthesia was given to 30 (10%) subjects. Of the 17 with a failed first insertion, two subjects did not want a second attempt, in 14 a second attempt succeeded, facilitated by cervical dilatation in seven and local anesthetic in three subjects. There was one failed insertion. Investigators rated 80% of first insertions as easy, 14% as slightly difficult and 6% as very difficult. The second insertion was easy in 9/15 subjects, slightly difficult in 4/15 and very difficult in one (data from one subject missing). During insertion, 34% subjects had no pain, 49% said it was mild, in 15% it was moderate and in 2% the pain was severe. At 12 months, one MLS had been expelled. Spotting was the most common form of bleeding and this decreased from a median of 9 to 0 days at 4 months, although 10% of subjects continued to report spotting up to 12 months. Bleeding days were few and mainly in the first 2 months. At the end of month 11, 66.8% were amenorrheic and 87% non-bleeding. Only nine subjects discontinued because of bleeding. There was no correlation between the bleeding profiles and number of years since menopause, previous HT use or body mass index. The median endometrial thickness at entry to the study (without HT) was 2.6 mm and 3.4 mm at 12 months. Of the adverse events, after the pain associated with insertion, headache was the next most common at 13.3% and mastalgia was experienced by 7.8% of subjects. Overall, the dropout rate was low at 28 subjects (9.5%). There were favorable changes in the serum lipid profile consistent with the effects of estradiol and suggesting minimal attenuation by the intrauterine progestogen. Conclusion This interim report of a 3-year study has confirmed that the menopausal levonorgestrel intrauterine system is easy to insert and is well tolerated by postmenopausal women.

Administration, Cutaneous↗
PubMed2006

Effect of nicotine on 35% CO2-induced anxiety: A study in healthy volunteers.

Panic disorder and cigarette smoking co-occur at a rate that exceeds what would be expected by chance. Theoretically, cigarette smoking may (a) attenuate panicky symptoms via cognitive factors or pharmacological action, (b) contribute to the development of panic disorder, or (c) share an etiological vulnerability with panic. The present study was aimed at testing whether nicotine has a direct influence on laboratory-elicited panic. In a placebo-controlled, double-blind, randomized, cross-over study, 33 healthy nonsmokers underwent a 35% CO2 challenge after transdermal administration of a nicotine patch on one test day and a placebo patch on another test day. Physiological measures (blood pressure, heart rate) and rating scale scores (Panic Symptom List [PSL], Visual Analog Scale of Anxiety, State-Trait Anxiety Inventory) were assessed. Compared with the placebo condition, nicotine increased diastolic blood pressure (p < .1), heart rate (p < .001), and PSL scores (p < .005) prior to the CO2 challenge but did not affect responding to the CO2 challenge itself. Results are consistent with the notion that nicotine promotes autonomic activation. However, the present study did not provide direct evidence that nicotine elicits panic in healthy volunteers. Replication in a clinical sample is warranted.

Adolescent↗