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L Speroff

Publications and source records attributed to L Speroff.

At least 37 records · Page 2Linked to original sources
PubMed1997

Postmenopausal hormone therapy into the 21st century.

At the time of the menopause, a review of the major health issues can be especially rewarding. Besides the general issues of good health, particular attention is now being focused on prevention of cardiovascular disease and osteoporosis because of the potentially beneficial effects of postmenopausal hormone therapy. Hormone therapy should be offered to most women as they consider their paths for successful aging. However, as for any pharmacological intervention, the benefits of treatment must outweigh the risk. The available data would appear to indicate that, for most women, this is in fact the case with current research into future hormonal therapies aimed at further improving the benefit:risk ratio.

Aged↗
PubMed1996

The comparative effect on bone density, endometrium, and lipids of continuous hormones as replacement therapy (CHART study). A randomized controlled trial.

OBJECTIVE: To compare the effect of continuous norethindrone acetate (NA)-ethinyl estradiol (EE2) combinations with matching unopposed EE2 or placebo. DESIGN: A 2-year, double-blind, placebo-controlled, parallel-group clinical trial. SETTING: Outpatients at 65 centers. PATIENTS: Asymptomatic or mildly symptomatic women aged 40 years or older who had undergone the onset of spontaneous menopause within the last 5 years and who had an intact uterus. INTERVENTIONS: Patients were equally randomized to placebo or 1 of 8 treatment groups: 0.2 mg of NA and 1 microg of EE2; 0.5 mg of NA and 2.5 microg of EE2; 1 mg of NA and 5 microg of EE2; 1 mg of NA and 10 microg of EE2; 1 microg of EE2; 2.5 microg of EE2; 5 microg of EE2; or 10 microg of EE2. PRIMARY OUTCOME MEASURES: Bone mineral density (BMD) measured by quantitative computed tomography, serum lipids, and endometrial effects as assessed by rate of hyperplasia and proliferative status. RESULTS: Twelve hundred sixty-five patients entered the study. Bone mineral density increased significantly from baseline (P<.001) in the 1 mg NA-5 microg EE2 and the 1 mg NA-10 microg EE2 treatment groups at each annual assessment. Among the unopposed EE2 groups, only the 10-microg group had increased BMD above baseline, but also was accompanied by an unacceptably high rate of endometrial hyperplasia. The NA-EE2 treatment groups had a significant linear dose-response trend for increasing BMD. Increased endometrial proliferation and hyperplasia occurred with increasing unopposed estrogen doses. The combination of NA and EE2 effectively protected the endometrium against hyperplasia. The percentage of change in the ratio of high-density lipoprotein cholesterol to low-density lipoprotein cholesterol was positive for all treatment groups. The increase in triglyceride levels associated with EE2 was attenuated with NA-EE2 treatment. CONCLUSIONS: Daily treatment with NA-EE2 was well tolerated and protected the endometrium from EE2-induced proliferation and hyperplasia. The NA-EE2 treatments produced a dose-related significant increase in BMD that was not present with unopposed EE2 treatment. The overall effect of NA-EE2 treatments on lipid measures was favorable.

Adult↗
PubMed1996

The case for postmenopausal hormone therapy.

Because randomized trials of the impact of hormone therapy on women's health are lacking, clinicians can only point out the benefits established in observational studies, discuss the potential risks, and allow each patient to decide for herself. Informed decision making is time-consuming, however. Ample educational materials and a counselor may facilitate the process.

Breast Neoplasms↗
PubMed1996

Performance of the TCu380A and Cu-Fix IUDs in an international randomized trail.

To compare the clinical performance of the TCu380A, the most widely used copper IUD in the world today, and a new frameless device, the Cu-Fix, we report results from a randomized international two-year clinical trial involving 874 parous women followed for an average of fourteen months. Event rates at the end of two years (per 100 women) for pregnancy were 0.0 for the TCu380A and 1.5 for the Cu-Fix. Termination due to expulsion was significantly less for TCu380A as compared with Cu-Fix users (2.0 and 11.4 per hundred women, respectively); other medical reasons for termination (bleeding/pain, pelvic inflammatory disease (PID), and other) did not differ significantly. PID incidence rates at two years were 1.0 per hundred women for the TCu380A and 1.6 for the Cu-Fix (equivalent to 6.0 and 8.3 per 1,000 woman-years, respectively). The net cumulative continuation rates at two years per hundred women were 78.8 for TCu380A, and 71.9 for the Cu-Fix. Both IUDs provide highly effective protection against pregnancy, but the TCu380A has a lower expulsion rate. The low rate of PID indicates that it is an in-frequent occurrence in appropriately selected candidates.

Adolescent↗
PubMed1996

Oral contraceptives and venous thromboembolism.

In October, 1995, the United Kingdom Committee on Safety of Medicines recommended that women should use oral contraceptives containing desogestrel or gestodene only if prepared to accept an increased risk of thromboembolism. This action was based on observational studies that indicated a 2-3-fold increase in the risk of thromboembolism when desogestrel and gestodene-containing contraceptives were compared to products with levonorgestrel. The fact that these studies point in the same direction is concerning, but it is possible that these observational studies, somewhat similar in design, are influenced by the same unrecognized biases. Furthermore, the case numbers are relatively small (20-40 cases), and, for example, preferential prescribing to women at greater risk could affect the results. It is difficult to reconcile the conclusions with the strong belief supported by good evidence that thrombosis is an estrogen dose-related complication, and that progestational agents have no impact on clotting parameters. In my view, these equivocal reports are not of sufficient strength to escape biases and to change our prescribing of oral contraceptives.

Clinical Trials as Topic↗
PubMed1996

Postmenopausal hormone therapy and breast cancer.

Given the magnitude of the older female population, the possibility that postmenopausal hormone therapy is associated with an increased risk of breast cancer is an issue of great public and individual importance. Epidemiologic evidence indicates the possibility of a slightly increased risk of breast cancer associated with long durations of postmenopausal estrogen use. However, in a review of the literature, it is apparent that the epidemiologic data are contradictory and do not yield uniform and consistent results. It is further apparent that adding a progestin to a postmenopausal hormone program does not alter the findings compared with the use of estrogen alone. Reasons for this disagreement and lack of definitive evidence are detailed, and it is suggested that any impact of postmenopausal hormone therapy on the risk of breast cancer is unlikely to be great. Finally, the question of whether a woman who has had breast cancer should use postmenopausal hormones is addressed.

Administration, Intravaginal↗
PubMed1996

Efficacy and local tolerance of a low-dose, 7-day matrix estradiol transdermal system in the treatment of menopausal vasomotor symptoms.

OBJECTIVE: To determine the efficacy and local tolerance of a new matrix transdermal drug-delivery system that delivers 0.02 mg of 17 beta-estradiol (E2) daily for 7 days for the relief of vasomotor symptoms. METHODS: A total of 324 surgically or naturally menopausal women, all with prior hysterectomy and moderate to severe vasomotor symptoms (56-140 hot flushes per week, with episodes of sweating, during a baseline observation period), participated in two independent, 12-week, randomized, double-blind, placebo-controlled studies. After a 4-week, treatment-free period, each woman received a continuous regimen of either one E2 transdermal system, two E2 transdermal systems, or placebo transdermal system(s) applied every week for 12 weeks. Efficacy was measured as reduction in hot flush frequency, determined from subject diaries. To measure local tolerance, skin irritation (erythema and edema) was objectively and systematically evaluated under blue light after removal of the transdermal system(s). Serum E2 and estrone concentrations were determined in one of the studies during baseline and on days 1, 9, 30, 58, 79, and 84. RESULTS: Mean hot flush frequency decreased from 80 hot flushes per week at baseline to approximately 13 hot flushes per week (84% decrease) after 12 weeks of transdermal E2 treatment. Compared with placebo, the decrease in hot flush frequency was significant as early as weeks 2 and 3, and was maintained through the end of the study. Few clinically significant skin reactions occurred, and only nine (3%) of the subjects withdrew because of a skin effect. After initial increase, serum E2 concentrations remained stable throughout the study, achieving values of approximately 20 and 40 pg/mL above baseline for one and two E2 transdermal systems, respectively. CONCLUSION: The E2 transdermal system effectively reduced the frequency of moderate to severe vasomotor symptoms as early as the second week of therapy and was very well tolerated. The decrease in hot flush frequency was similar to that reported for oral and other transdermal estrogens, but at lower serum E2 concentrations. This result may be due to the stable E2 blood level achieved with this transdermal system.

Administration, Cutaneous↗
PubMed1996

Effects of estrogen and progestin on aortic size and compliance in postmenopausal women.

OBJECTIVE: Our purpose was to determine whether sex steroids alter aortic size and compliance in postmenopausal women. STUDY DESIGN: Twenty-six postmenopausal women were randomized to receive either conjugated estrogens 0.625 mg per day (group 1) or conjugated estrogens 0.625 mg per day and medroxyprogesterone 2.5 mg per day (group 2). Aortic cross-sectional area was measured by magnetic resonance imaging before and after 3 months of hormone therapy. RESULTS: Estradiol levels increased in both group 1 and group 2 (p < 0.0001). Ascending aortic cross-sectional area increased from 439 +/- 7 mm2 to 466 +/- 7 mm2 in group 1 (p < 0.008) but was unchanged in group 2. Within the range of aortic pressures studied, no change in aortic compliance could be detected. CONCLUSION: Estrogen therapy in postmenopausal women was associated with an increase in aortic size; but this effect was not detectable with the addition of progestin. The potential antagonistic effect of progestin on estrogen-induced aortic enlargement suggests that the favorable cardiovascular effects of postmenopausal estrogen therapy cannot be automatically extended to the combination estrogen-progestin.

Aorta, Thoracic↗
PubMed1994

The effect of aging on fertility.

In the developed world, deferment of marriage and postponement of child-bearing in marriage are resulting in unprecedented numbers of couples who desire pregnancy relatively late in life. These factors combine with a decline in fertility and an increase in pregnancy wastage with advancing age to present new challenges for the clinician treating infertility. Experience with young oocytes donated to older women indicates that the major responsibility for the decline in fertility with age can be attributed to aging oocytes. Oocyte donation offers new hope for infertile older woman, but important moral and social questions remain unanswered.

Age Factors↗
PubMed1993

A comparison of esterified estrogens with and without methyltestosterone: effects on endometrial histology and serum lipoproteins in postmenopausal women.

OBJECTIVE: To compare the efficacy and safety of esterified estrogens with and without methyltestosterone. METHODS: Twenty-six women participated in a double-blind randomized trial for 6 months. Outcome measures included serum total and lipoprotein-bound cholesterol, vasomotor symptoms, vaginal cytology and endometrial histology, and chemistry values. Analysis of variance and t test statistics were used to assess differences. RESULTS: After 6 months of therapy, the treatment groups were comparable with regard to symptom scores, vaginal cytology and endometrial histology scores, and clinical laboratory test values. Treatment with esterified estrogens plus methyltestosterone significantly decreased total cholesterol, high-density lipoprotein cholesterol (HDL), HDL2, HDL3, and apolipoprotein A1 compared to esterified estrogens alone. CONCLUSIONS: Esterified estrogens with or without methyltestosterone were effective at reducing menopausal symptoms and were well tolerated over 6 months of continuous treatment. A significant decrease in cholesterol and apolipoproteins in the estrogen plus methyltestosterone group suggests a potentially adverse impact on the beneficial effect normally imparted by estrogen therapy.

Adult↗