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Top results for estradiol

21. Subcutaneous implantation of estradiol pellets for postmenopausal disorders

Subcutaneous implantation of estradiol pellets for postmenopausal disorders Subcutaneous implantation of estradiol pellets for postmenopausal disorders Subcutaneous implantation of estradiol pellets for postmenopausal disorders Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation Subcutaneous implantation of estradiol pellets for postmenopausal disorders. Lansdale (...) replacement therapy (HRT), which typically involves administration of estrogen and progesterone via pills, skin patches, or gels. Final publication URL The report may be purchased from: Indexing Status Subject indexing assigned by CRD MeSH Estradiols; Postmenopause Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax

2012 Health Technology Assessment (HTA) Database.

22. Zoely - nomegestrol / estradiol

Zoely - nomegestrol / estradiol 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union Assessment report Zoely International Non proprietary Name: nomegestrol/estradiol Procedure No. EMEA/H/C/001213 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted Table of contents 1. Background (...) exception contain 17- alpha-ethinylestradiol (EE) and some first generation combined hormonal contraceptives contain mestranol. 19-nor-testosteron derivatives have, besides their gestagenic effects, mild to moderate androgenic effects and might have negative impact on the lipid metabolism. They can also cause intrahepatic cholestasis. Nomegestrol Acetate (NOMAC) is a highly selective progestin derived from the naturally occurring steroid hormone, progesterone. The 17 ß-estradiol (E2) compound

2011 European Medicines Agency - EPARs

23. Ioa - nomegestrol acetate / estradiol

Ioa - nomegestrol acetate / estradiol 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8613 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union Assessment report Ioa nomegestrol/estradiol Procedure No.: EMEA/H/C/002068 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Medicinal product no longer authorisedIoa CHMP assessment (...) Pharmaceutical Ingredient AST Aspartate Aminotransferase AUC Area Under the Curve BE Bioequivalence BMI Body Mass Index CI Confidence Interval Cmax Maximum Plasma Concentration Cmax,ss,cor Maximum Plasma Concentration at steady state, corrected for the residual concentration of previous doses CBG Corticosteroid Binding Globulin COC Combined Oral Contraceptive CRP C-reactive protein CTR Clinical trial report DRSP-EE Drospirenone - Ethinyl Estradiol E1 Estrone E1S Estrone sulphate E2 17 ß-estradiol FD Follicle

2011 European Medicines Agency - EPARs

24. Subcutaneous implantation of estradiol pellets for postmenopausal disorders

Subcutaneous implantation of estradiol pellets for postmenopausal disorders Subcutaneous implantation of estradiol pellets for postmenopausal disorders Subcutaneous implantation of estradiol pellets for postmenopausal disorders Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation Subcutaneous implantation of estradiol pellets for postmenopausal disorders. Lansdale (...) by use of hormone replacement therapy (HRT), which typically involves administration of estrogen and progesterone via pills, skin patches, or gels. Timeliness warning This report has been archived and may contain outdated information. To request a copy of the report please contact the organisation directly. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Drug Implants; Estradiol; Estrogen Replacement Therapy; Females; Menopause Language Published English Country

2011 Health Technology Assessment (HTA) Database.

25. Norethindrone and Ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets

Norethindrone and Ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets Drug Approval Package: Norethindrone and Ethinyl estradiol NDA #022573 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Norethindrone and Ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets Company: Warner Chilcott, LLC Application No.: 022573 Approval Date: 12/22/2010 Persons with disabilities having problems accessing the PDF files below may

2010 FDA - Drug Approval Package

26. Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets)

Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) Drug Approval Package: Safyral (drospirenone/ethinyl estradiol) NDA #022574 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) Company: Bayer HealthCare Pharmaceuticals Inc. Application No.: 022574 Approval Date: 12/16/2010 Persons with disabilities

2010 FDA - Drug Approval Package

27. Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate tablets)

Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate tablets) Drug Approval Package: Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate) NDA #022501 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets, and ferrous fumarate tablets

2010 FDA - Drug Approval Package

28. Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium)

Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium) Drug Approval Package: Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium) NDA #022532 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium) tablets Company: Bayer HealthCare Pharmaceuticals Inc. Application No.: 022532 Approval Date: 09/24/2010 Persons

2010 FDA - Drug Approval Package

29. Subcutaneous implantation of estradiol pellets for postmenopausal disorders

Subcutaneous implantation of estradiol pellets for postmenopausal disorders Subcutaneous implantation of estradiol pellets for postmenopausal disorders Subcutaneous implantation of estradiol pellets for postmenopausal disorders Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation Subcutaneous implantation of estradiol pellets for postmenopausal disorders. Lansdale

2010 Health Technology Assessment (HTA) Database.

30. Relationship between higher estradiol levels and 9-year mortality in older women: the Invecchiare in Chianti study Full Text available with Trip Pro

Relationship between higher estradiol levels and 9-year mortality in older women: the Invecchiare in Chianti study To investigate the relationship between total estradiol (E2) levels and 9-year mortality in older postmenopausal women not taking hormone replacement therapy (HRT).Population-based study of persons living in the Chianti geographic area (Tuscany, Italy).Community.A representative sample of 509 women aged 65 and older with measures of total E2.Serum total E2 was measured

2009 EvidenceUpdates

31. Circulating estradiol and mortality in men with systolic chronic heart failure. Full Text available with Trip Pro

Circulating estradiol and mortality in men with systolic chronic heart failure. Androgen deficiency is common in men with chronic heart failure (HF) and is associated with increased morbidity and mortality. Estrogens are formed by the aromatization of androgens; therefore, abnormal estrogen metabolism would be anticipated in HF.To examine the relationship between serum concentration of estradiol and mortality in men with chronic HF and reduced left ventricular ejection fraction (LVEF (...) ).A prospective observational study at 2 tertiary cardiology centers (Wroclaw and Zabrze, Poland) of 501 men (mean [SD] age, 58 [12] years) with chronic HF, LVEF of 28% (SD, 8%), and New York Heart Association [NYHA] classes 1, 2, 3, and 4 of 52, 231, 181, and 37, respectively, who were recruited between January 1, 2002, and May 31, 2006. Cohort was divided into quintiles of serum estradiol (quintile 1, < 12.90 pg/mL; quintile 2, 12.90-21.79 pg/mL; quintile 3, 21.80-30.11 pg/mL; quintile 4, 30.12-37.39 pg/mL

2009 JAMA

32. Breast cancer risk in postmenopausal women using estradiol-progestogen therapy (Abstract)

Breast cancer risk in postmenopausal women using estradiol-progestogen therapy To estimate the risk for breast cancer in Finnish women using postmenopausal estradiol (E2)-progestogen therapy.All Finnish women over 50 years using E2-progestogen therapy for at least 6 months in 1994-2005 (N=221,551) were identified from the national medical reimbursement register and followed up for breast cancer incidence (n=6,211 cases) through the Finnish Cancer Registry to the end of 2005. The risk for breast

2009 EvidenceUpdates

33. Lower-dose vs high-dose oral estradiol therapy of hormone receptor-positive, aromatase inhibitor-resistant advanced breast cancer: a phase 2 randomized study. Full Text available with Trip Pro

Lower-dose vs high-dose oral estradiol therapy of hormone receptor-positive, aromatase inhibitor-resistant advanced breast cancer: a phase 2 randomized study. Estrogen deprivation therapy with aromatase inhibitors has been hypothesized to paradoxically sensitize hormone-receptor-positive breast cancer tumor cells to low-dose estradiol therapy.To determine whether 6 mg of estradiol (daily) is a viable therapy for postmenopausal women with advanced aromatase inhibitor-resistant hormone receptor (...) -positive breast cancer.A phase 2 randomized trial of 6 mg vs 30 mg of oral estradiol used daily (April 2004-February 2008 [enrollment closed]). Eligible patients (66 randomized) had metastatic breast cancer treated with an aromatase inhibitor with progression-free survival (> or = 24 wk) or relapse (after > or = 2 y) of adjuvant aromatase inhibitor use. Patients at high risk of estradiol-related adverse events were excluded. Patients were examined after 1 and 2 weeks for clinical and laboratory

2009 JAMA Controlled trial quality: predicted high

34. Ethinyl estradiol 30 µg and levonorgestrel 150 µg (Seasonale) for prevention of pregnancy

Ethinyl estradiol 30 µg and levonorgestrel 150 µg (Seasonale) for prevention of pregnancy Ethinyl estradiol 30 µg and levonorgestrel 150 µg (Seasonale) for prevention of pregnancy | Therapeutics Initiative Independent Healthcare Evidence > > Ethinyl estradiol 30 µg and levonorgestrel 150 µg (Seasonale) for prevention of pregnancy This is the summary of a systematic review assessing the comparative safety and efficacy of Seasonale (ethinyl estradiol 30 μg, levonorgestrel 150 μg, extended 91-day (...) cycle), in the prevention of pregnancy in sexually active women of reproductive age. Drug This oral contraceptive (OC) combines an estrogen, ethinyl estradiol (EE) 30 μg, and a progestin, levonorgestrel (LNG)150 μg, commonly contained in other OCs in Canada. Duration of active treatment for this product is 84 days, followed by 7 days of placebo. It is the only product available in Canada that is specifically formulated for extended-cycle use. The aim of this formulation, in addition to pregnancy

2009 Therapeutics Letter

35. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial (Abstract)

Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial To investigate the safety and efficacy of a transdermal estradiol (E2) spray in women with postmenopausal vasomotor symptoms.A randomized, double-blind, placebo-controlled, multicenter, parallel-group clinical trial was conducted. Postmenopausal women (N=454) with at least eight moderate-to-severe hot flushes per day applied daily, one, two, or three E2 (90 microliter spray contains 1.53 mg E2) or matching

2008 EvidenceUpdates Controlled trial quality: predicted high

36. The effect of ultralow-dose transdermal estradiol on sexual function in postmenopausal women (Abstract)

The effect of ultralow-dose transdermal estradiol on sexual function in postmenopausal women This study was undertaken to examine the effect of ultralow-dose transdermal estradiol on sexual function in postmenopausal women.Analysis of data from a multicenter, randomized, double-blind, placebo-controlled trial of a 0.014 mg/day transdermal estradiol patch in 417 women aged 60 to 80 years. Sexual function was assessed by self-administered questionnaires at baseline and 4, 12, and 24 months (...) . A linear effects model was used to assess treatment effects using data from all on-study assessments.Women randomly assigned to estradiol had a 4.3 point greater improvement in the vaginal pain/dryness domain relative to placebo (95% CI = 0.3-8.4, P = .04). No significant differences in frequency of sexual activity or other sexual function domains (desire, satisfaction, problems, or orgasm) were observed between treatment groups (P > or = .10 for all).Ultralow-dose estradiol resulted in modest

2008 EvidenceUpdates Controlled trial quality: predicted high

37. The use of estradiol for luteal phase support in in vitro fertilization/intracytoplasmic sperm injection cycles: a systematic review and meta-analysis

The use of estradiol for luteal phase support in in vitro fertilization/intracytoplasmic sperm injection cycles: a systematic review and meta-analysis Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.

2008 DARE.

38. Lowest Effective Transdermal 17{beta}-Estradiol Dose for Relief of Hot Flushes in Postmenopausal Women: A Randomized Controlled Trial. (Abstract)

Lowest Effective Transdermal 17{beta}-Estradiol Dose for Relief of Hot Flushes in Postmenopausal Women: A Randomized Controlled Trial. OBJECTIVE: To investigate the efficacy of micro-dose transdermal estrogen in relieving menopausal vasomotor symptoms. METHODS: A randomized, double-blind, placebo-controlled, multi-center trial. Healthy postmenopausal women with at least seven moderate or severe hot flushes per day for at least 1 week, or at least 50 per week, applied transdermal patches (...) with a nominal delivery of 0.023 mg/d 17beta-estradiol and 0.0075 mg/d levonorgestrel (low-dose E2/levonorgestrel; n=145), 0.014 mg/d E2 (micro-dose; n=147), or placebo (n=133) for 12 weeks. The coprimary efficacy variables were the mean changes from baseline in frequency and severity of moderate and severe hot flushes at the week 4 and 12 endpoints. RESULTS: At the week 12 endpoint, mean weekly frequencies of moderate and severe hot flushes were significantly reduced compared with placebo with low-dose E2

2007 EvidenceUpdates Controlled trial quality: predicted high

39. Yaz (drospirenone 3mg/ethinyl estradiol 0.02mg)

Yaz (drospirenone 3mg/ethinyl estradiol 0.02mg) Drug Approval Package: YAZ (drospirenone 3mg/ethinyl estradiol 0.02mg) NDA #022045 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - YAZ (drospirenone 3mg/ethinyl estradiol 0.02mg) Tablets Company: Berlex, Inc. Application No.: 022045 Approval Date: 01/26/2007 (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created: February 22, 2008 Updated: October 3, 2011 Note: Documents in PDF format require

2007 FDA - Drug Approval Package

40. Etonogestrel/ethinyl estradiol

Etonogestrel/ethinyl estradiol Common Drug Review CEDAC Meeting – October 18, 2006 Page 1 of 2 Notice of CEDAC Final Recommendation – November 29, 2006 CEDAC FINAL RECOMMENDATION and REASONS for RECOMMENDATION ETONOGESTREL/ETHINYL ESTRADIOL (NuvaRing TM - Organon Canada Ltd.) Description: NuvaRing TM is a contraceptive vaginal ring containing two active components, etonogestrel and ethinyl estradiol. Dosage Forms: NuvaRing TM contains 11.4 mg etonogestrel and 2.6 mg ethinyl estradiol (...) and releases, on average, 120 µg/day of etonogestrel and 15 µg/day of ethinyl estradiol over a three week period of use. Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that NuvaRing TM be listed on the condition that the amount paid by drug plans for NuvaRing TM per cycle not exceed the current maximum paid for oral contraceptives. Reasons for the Recommendation: 1. The Committee considered a systematic review of randomized controlled trials (RCTs) of at least six months

2007 Canadian Agency for Drugs and Technologies in Health - Common Drug Review