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Latest & greatest articles for estradiol
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Yaz (drospirenone/ethinyl estradiol) for Oral Contraception and Premenstrual Dysphoric Disorder Drug Approval Package: Yaz (drospirenone/ethinyl estradiol) NDA #021873 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Yaz (drospirenone/ethinyl estradiol) for Oral Contraception and Premenstrual Dysphoric Disorder Company: Berlex, Inc. NDA: 021873 Approval Date: 10/4/2006 (PDF) (PDF) (PDF) Medical Review(s) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF
drospirenone /ethinyl estradiol CEDAC FINAL RECOMMENDATION and REASONS for RECOMMENDATION DROSPIRENONE / ETHINYL ESTRADIOL (Yasmin ® – Berlex Canada Inc.) Description: Yasmin® is a monophasic combination of drospirenone 3 mg and ethinyl estradiol 0.03 mg, approved for oral conception control. Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that the combination of drospirenone 3 mg and ethinyl estradiol 0.03 mg be listed. Reasons for the recommendation: 1. Efficacy (...) is similar to currently available monophasic combination oral contraceptives with different progestogen but same ethinyl estradiol concentration. 2. Safety appears to be similar to currently available monophasic combination oral contraceptives with different progestogen but same ethinyl estradiol concentration. 3. Cost is similar compared to currently available monophasic combination oral contraceptives with different progestogen but same ethinyl estradiol concentration. Of Note: 1. Drosperinone is a new
norgelestromin/ethinyl estradiol RECOMMENDATION on RECONSIDERATION and REASONS for RECOMMENDATION NORELGESTROMIN/ETHINYL ESTRADIOL transdermal patch (Evra—Janssen-Ortho Inc.) Description: Norelgestromin/ethinyl estradiol is a transdermal combination estrogen/progestin patch indicated for contraception. Recommendation on Reconsideration: CEDAC recommends that the norelgestromin/ethinyl estradiol transdermal patch not be listed. Reasons for the recommendation: 1. In the two randomized controlled (...) trials comparing the norelgestromin/ethinyl estradiol transdermal patch with oral contraceptives that evaluated pregnancy rates, the pregnancy rates were similar (pregnancy rate 0.6% vs 1.2%; 0.5% vs 0.3%). 2. In all 3 randomized trials that reported withdrawals, the withdrawal rate was higher in the patients receiving the transdermal patch. These differences were statistically significant in two trials. 3. In all 3 randomized controlled trials that reported withdrawals because of adverse effects
Ultralow-dose micronized 17beta-estradiol and bone density and bone metabolism in older women: a randomized controlled trial. Estrogen therapy is known to prevent osteoporosis, but studies have shown that conventional doses increase adverse events. Whether lower doses, one quarter of standard treatment, prevent bone loss is not known.To examine the effect of 3 years of treatment with 0.25 mg/d of micronized 17beta-estradiol on bone mineral density (BMD) and bone turnover in healthy older (...) postmenopausal women.Randomized, double-blind, placebo-controlled trial conducted from July 24, 1998, through June 14, 2002, at a university general clinical research center in the United States. Healthy, community-dwelling women (N = 167) who were older than 65 years at enrollment.Dosage of 0.25 mg/d of micronized 17beta-estradiol (n = 83) or placebo (n = 84); all women who had not had a hysterectomy received 100 mg/d of oral micronized progesterone for 2-week periods every 6 months.The BMD of the hip
Serum estradiol level and risk of breast cancer during treatment with raloxifene. As endogenous estradiol increases, risk of breast cancer increases. Raloxifene competes with endogenous estrogen for binding to estrogen receptors in breast tissue. A woman's estradiol level may alter the effects of raloxifene on breast cancer and other outcomes.To test the hypothesis that raloxifene reduces breast cancer risk more in women with relatively high estradiol levels than in women with very low (...) estradiol levels.Analysis of the Multiple Outcomes of Raloxifene Evaluation, a randomized, double-blind, placebo-controlled trial conducted from 1994 to 1999.One hundred eighty community settings and medical practices in 25 countries including the United States.A total of 7290 postmenopausal women aged 80 years or younger with osteoporosis who had baseline serum estradiol concentrations measured by a central laboratory using a sensitive assay. Women with a history of breast cancer or estrogen use were
Plasma lipids and desogestrel and ethinyl estradiol: a meta-analysis Plasma lipids and desogestrel and ethinyl estradiol: a meta-analysis Plasma lipids and desogestrel and ethinyl estradiol: a meta-analysis Lobo R A, Skinner J B, Lippman J S, Cirillo S J Authors' objectives To review the literature to determine the magnitude of effect of 150 microg desogestrel combined with 30 microg ethinyl E2, an oral contraceptive (OC) formulation, on plasma lipid concentrations in healthy women using meta (...) , the review does provide good detail on the methods used to combine the primary studies and a thorough discussion. Bibliographic details Lobo R A, Skinner J B, Lippman J S, Cirillo S J. Plasma lipids and desogestrel and ethinyl estradiol: a meta-analysis. Fertility and Sterility 1996; 65(6): 1100-1109 PubMedID Indexing Status Subject indexing assigned by NLM MeSH Cholesterol /blood; Cholesterol, HDL /blood; Cholesterol, LDL /blood; Contraceptives, Oral /adverse effects /pharmacology; Desogestrel /adverse