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. Either placebo or 17beta-estradiol (1 mg or 0.5 mg) was given orally every day for 12 weeks, and vasomotor symptoms and vaginal epithelial cytology were evaluated. RESULTS: There were significant differences between placebo and the active treatments in the percentage change from baseline in the number of hot flushes (all hot flushes, 1 mg vs. placebo, p < 0.00 1; 0.5 mg vs. placebo, p = 0.007), with a more substantial proportion of subjects responding in the 1-mg group (mean change in mean number of hot flushes of 83.2%). Both doses were also more effective than placebo in increasing the proportion of mature vaginal cells (end-of-treatment mean values of 0%, 78.5%, and 21.5% for parabasal, intermediate, and superficial cells, respectively, in the 1-mg group; mean values of 0.3%, 80.8%, and 18.9% in the 0.5-mg group; and mean values of 15.2%, 74.7%, and 10.2% in the placebo group). The proportion of subjects reporting no vaginal dryness was greatest in the 1-mg group (mean percentage of days without dryness of 86.1% at weeks 9-12). CONCLUSIONS: For the relief of vasomotor and vulvovaginal symptoms, 17beta-estradiol I mg is effective and has an excellent safety profile.

Administration, Oral↗

PubMedDate not supplied

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. Plasma estradiol concentrations were used to estimate pharmacokinetic parameters for the rate and extent of absorption between the two sites. RESULTS: Plasma estradiol concentrations were sustained at premenopausal levels over the week in most subjects. After application on the buttock, mean peak plasma concentration (Cmax) was 125.1% and mean relative bioavailability (AUC(0-168)) was 117.2% of that from the abdomen site. CONCLUSIONS: In summary, the buttocks seem to be an acceptable site for the application for this once-weekly 17-beta estradiol transdermal delivery system. Because the extent of absorption was significantly more for buttock than for abdomen application, this application site may provide an advantage in women who experience menopausal symptoms at the end of the week.

Abdomen↗

PubMedDate not supplied

Urogenital atrophy and low-dose vaginal estrogen therapy.

Explore the source record for details and available documents.

Administration, Intravaginal↗

PubMedDate not supplied

Hormonal therapy in climacteric women: compliance and its socioeconomic impact.

Hormonal therapy can effectively enhance the quality of life for postmenopausal women, and prevent climacteric-related conditions such as osteoporosis. Since long-term therapy is often required, compliance becomes an important issue. This can best be achieved by measurement, documenting the reason for hormone therapy, and by repeated measurement, demonstrating a response to the treatment. Case histories documenting this principle are described.

Adult↗

PubMedDate not supplied

Climacteric medicine: cornerstone for midlife health and wellness.

Midlife care should consider the whole woman, with preventive attention to osteoporosis and cardiovascular disease. A new delivery system, using a skin patch, is available for replacement or additive hormonal therapy. Useful hormonal therapy may include both estrogen and progesterone.

Adult↗