Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial.

Objective: To evaluate the efficacy of two vaginal doses of estradiol (E2) compared with placebo in the treatment of atrophic vaginitis.

Methods: In a multi-center, randomized, double-blind, parallel-group study, 230 postmenopausal women received treatment with 25 mcg or 10 mcg E2 or placebo for 12 weeks. Efficacy was measured through composite score of three vaginal symptoms and grading of vaginal health.

Postmenopausal tibolone therapy: biologic principles and applied clinical practice.

Although the menopause is a generic physiologic event, its biology is variable and specific to a given individual. Genetically determined distribution and polymorphism of relevant hormone receptors, enzymes, and various cofactors are the biologic mechanisms controlling an individual's clinical response to endogenous and prescribed hormones. Advances in molecular biology have led to the development of newer pharmacologic agents that are tailored to meet specific therapeutic objectives, based on the hormonal biology of relevant organs.

Should symptomatic menopausal women be offered hormone therapy?

Unlabelled: Many physicians remain uncertain about prescribing hormone therapy for symptomatic women at the onset of menopause. The American Society for Reproductive Medicine (ASRM) convened a multidisciplinary group of healthcare providers to discuss the efficacy and risks of hormone therapy for symptomatic women, and to determine whether it would be appropriate to treat women at the onset of menopause who were complaining of menopausal symptoms.

Major Findings: Numerous controlled clinical trials consistently demonstrate that hormone therapy, administered via oral, transdermal, or vaginal routes, is the most effective treatment for vasomotor symptoms.

Should symptomatic menopausal women be offered hormone therapy?

Unlabelled: Many physicians remain uncertain about prescribing hormone therapy for symptomatic women at the onset of menopause. The American Society for Reproductive Medicine (ASRM) convened a multidisciplinary group of healthcare providers to discuss the efficacy and risks of hormone therapy for symptomatic women, and to determine whether it would be appropriate to treat women at the onset of menopause who were complaining of menopausal symptoms.

Major Findings: Numerous controlled clinical trials consistently demonstrate that hormone therapy, administered via oral, transdermal, or vaginal routes, is the most effective treatment for vasomotor symptoms.

Clinical opinion: the biologic and pharmacologic principles of estrogen therapy for symptomatic menopause.

The endocrinology of the menopausal transition involves a complex interaction of molecular and tissue-specific hormone receptors, enzymes, and moderating cofactors that determine the functional expression of a given organ. The synthesis and metabolism of estrogen in estrogen-sensitive organs continue postmenopausally, albeit at levels substantially reduced from those of reproductive women. The postmenopausal production of estrogen is genetically determined.

Clinical opinion: the biologic and pharmacologic principles for age-adjusted long-term estrogen therapy.

The pathophysiologies of osteoporosis, cardiovascular disease, and breast cancer are briefly reviewed within the context of the relevance and safety of long-term estrogen therapy (ET). Extrapolation of data from the known underlying biology of these diseases and the results of randomized controlled clinical trials suggest that selective ET is appropriate and safe for the majority of postmenopausal women. A key element to this clinical practice is individualization of ET, which includes timing of the initiation of therapy, selection of the route and possibly the type of estrogen prescribed, adjustment of the dose of estrogen over time to compensate for local tissue estrogen synthesis, and annual monitoring and reassessment of the indication for continuing therapy.

Postmenopausal hormone therapy before and after the women's health initiative study: what consequences?

This review focuses on the question of whether the Women's Health Initiative (WHI) was a test of primary versus secondary cardiovascular benefits of postmenopausal hormone therapy. Evidence is presented to support the conclusion that the WHI was a secondary intervention trial and that primary cardiovascular benefits of hormone therapy are rational, likely, but not yet proven. The review makes clear that hormone therapy is not a 'cardiovascular drug' for the treatment of coronary heart disease; but rather that the public health debate is whether hormone therapy, used for the treatment of menopausal symptoms, provides any cardiovascular benefits that might offset its risk.

Hot flashes and androgens: a biological rationale for clinical practice.

Hot flashes are the most prevalent symptom of menopause. Although the etiology of hot flashes has yet to be determined, it is increasingly apparent that the physiology of the underlying vasomotor instability is multifactorial. Estrogen and androgen receptors are present in the areas of the central nervous system relevant to hot flashes.

Effectiveness of Alora estradiol matrix transdermal delivery system in improving lumbar bone mineral density in healthy, postmenopausal women.

Objective: To determine the lowest effective dose of an estradiol (E ) matrix-type transdermal delivery system (EMTDS; Alora) for preventing bone loss in postmenopausal women.

Design: This double-blind, double-dummy, randomized, placebo-controlled, multicenter study enrolled 355 nonosteoporotic postmenopausal women who had been hysterectomized with or without oophorectomy at least 12 months earlier. Participants were randomly assigned to one of three doses of the EMTDS (0.

Estradiol absorption from vaginal tablets in postmenopausal women.

Objective: To evaluate absorption of estradiol (E2) and compare two low doses of 17 beta-E2 (25 microgram and 10 microgram) in postmenopausal women with atrophic vaginitis.

Methods: In a double-masked, randomized, parallel-group study, 58 postmenopausal women were treated with 25 microgram or 10 microgram of 17 beta-E2 for 12 weeks. We report data for 42 eligible subjects who had serum E2 concentrations below 20 pg/mL at baseline and complete data available at the baseline visit (30 minutes before tablet insertion) and weeks 2 and 12.

Androgen effects on bone and muscle.

Bone health and strength are dependent on the coupling of cone resorption and bone formation. This process is governed by the interaction of osteoclasts and osteoblasts plus the modulating influence of the bone mechanicosensory cells-the osteocytes. Both sex steroids-estrogen (E) and testosterone (T)- have receptors on all bone cells, with androgen dominance on osteoblasts and osteocytes.

Female androgen insufficiency: the Princeton consensus statement on definition, classification, and assessment.

Objective: To evaluate the evidence for and against androgen insufficiency as a cause of sexual and other health-related problems in women and to make recommendations regarding definition, diagnosis, and assessment of androgen deficiency states in women.

Design: Evaluation of peer-review literature and consensus conference of international experts.

Setting: Multinational conference in the United States.

Overview of bone mineral density in postmenopausal women.

The risk of osteoporosis is directly related to factors that influence bone remodeling premenopausally and postmenopausally. Some of these factors are nonmodifiable--for example, race and the genetic control of osteogenesis. Other factors, such as lifestyle, exercise and nutrition, can be influenced to enhance bone mineral accrual and thereby lessen the risk of or even prevent osteoporosis.

Effects of estrogen/androgen therapy on bone mineral density parameters.

Although estrogen's efficacy in reversing loss of bone mineral density (BMD) has been extensively documented, the role of androgens in preserving and restoring BMD is less well understood. Estrogen/androgen (E/A) therapy is especially important for surgically menopausal women. This population group experiences marked bone loss in response to the dramatic decline in ovarian hormones.

The effect of site of application on the transcutaneous absorption of 17-beta estradiol from a transdermal delivery system (Climara).

Objective: The effect of site of application on 17-beta estradiol bioavailability was assessed in an open-label, randomized, crossover study of a once-weekly transdermal estradiol patch (Climara).

Design: After placement of a transdermal patch delivering 0.1 mg/day of estradiol on either the buttocks or abdomen, serial plasma samples were obtained over 7 days and for the immediate 24 h after patch removal.

Suppression of vasomotor and vulvovaginal symptoms with continuous oral 17beta-estradiol.

Objectives: To evaluate the efficacy and safety of different doses of 173-estradiol for the treatment of vasomotor and vulvovaginal symptoms.

Design: This was a randomized, double-blind, multicenter, parallel-group study. One hundred forty-five subjects, including naturally postmenopausal women aged 40-60 (who had not experienced menses for at least 12 months), women who had undergone hysterectomy, and women aged 25-60 who had undergone bilateral oophorectomy with or without hysterectomy were studied.

Initial 17beta-estradiol dose for treating vasomotor symptoms.

Objective: To compare the efficacy of different doses of 17beta-estradiol (E2) for relief of vasomotor symptoms in menopausal women.

Methods: This was a randomized, double-masked, placebo-controlled, 12-week study in which 333 menopausal women with moderate or severe hot flushes were assigned to treatment with 0.25 mg, 0.

A two-year, double-blind comparison of estrogen-androgen and conjugated estrogens in surgically menopausal women. Effects on bone mineral density, symptoms and lipid profiles.

Objective: To compare the effects of two doses of conjugated equine estrogen (CEE) and two of esterified estrogen plus methyltestosterone (E + A) in surgically menopausal women.

Study Design: A two-year, parallel-group, double-blind study of 311 women who were randomly assigned to one of four regimens: (1) CEE, 0.625 mg/d; (2) CEE, 1.

Efficacy of continuous sequential transdermal estradiol and norethindrone acetate in relieving vasomotor symptoms associated with menopause.

Objective: This study was undertaken to evaluate the efficacy and tolerability of a combination estradiol plus norethindrone acetate transdermal delivery system given in a continuous sequential regimen with transdermal estradiol versus placebo in the treatment of vasomotor symptoms of menopause.

Study Design: This was a 12-week double-blind trial of 220 healthy postmenopausal women with > or = 8 moderate to severe hot flushes and sweating episodes per day. Women were randomly assigned to wear transdermal placebo patches or a transdermal patch releasing 50 microg/d 17beta-estradiol alone (Vivelle) for days 1 to 14 of each cycle and a combination patch releasing 50 microg/d 17beta-estradiol plus 1 of 3 dosage levels (140, 250, or 400 microg/d) of norethindrone acetate (CombiPatch) for days 15 through 28.