Study Ar M N Rxcat Dose Rout E Generic Trade Est Dose Polvani

Total Page:16

File Type:pdf, Size:1020Kb

Study Ar M N Rxcat Dose Rout E Generic Trade Est Dose Polvani Table E-51. Therapies used in trials comparing hormone with hormone Ar Rout Est Generic Trade Study m N RxCat Dose e Dose 0.625 mg E + 10 conjugated equine estrogens + medroxyprogesterone Standar Polvani 1991 1 170 EP seq mg P Oral acetate d 0.05 mg E + 10 estradiol + medroxyprogesterone acetate Standar 2 203 EP seq mg P Patch d Henriksson VayRi estradiol Silastic 1994 1 106 Est 0.0095mg n Low VagP estriol Ovesterin 2 51 Est 0.5mg es Low 0.625 mg E + 20 conjugated estrogen + Premarin + Duphaston Standar Studd 1995 1 104 EP seq mg P Oral dydrogesterone d 0.05 mg E + 20 estradiol + dydrogesterone Menorest + Duphaston Standar 2 100 EP seq mg P Patch d VayRi estradiol Estring Ayton 1996 1 131 Est 0.0075mg n Low VagC conjugated estrogen Premarin Standar 2 63 Est 0.625mg rm d E-96 Ar Rout Est Generic Trade Study m N RxCat Dose e Dose 0.625mg E + conjugated equine estrogen + Premarin + Provera Standar Hilditch 1996 1 35 EP seq 10mg P Oral medroxyprogesterone acetate d 0.014mg E + estradiol + medroxyprogesterone Estraderm + Provera UltraLo 2 39 EP seq 10mg P Patch acetate w estradiol valerate + Dilena or Divina Egarter 1996 1 51 EP seq 2mg E + 10mg P Oral medroxyprogesterone acetate High 0.625mg E + conjugated estrogen + Premarin + Colpron Standar 2 50 EP seq 10mg P Oral medrogestone d Hirvonen 1.0 mg E + 10 mg SknG estradiol + peroral Divigel + Terolut 1997 1 60 EP seq P el dydrogesterone Low 0.05 mg E + 10 estradiol + peroral Estraderm + Terolut Standar 2 60 EP seq mg P Patch dydrogesterone d Hirvonen SknG estradiol + medroxyprogesterone Divigel + Provera 1997 1 84 EP seq 1 mg E + 20 mg P el acetate Low SknG estradiol + medroxyprogesterone Divigel + Provera Standar 2 32 EP seq 2 mg E + 10 mg P el acetate d estradiol valerate + Divina 3 57 EP seq 2 mg E + 10 mg P Oral medroxyprogesterone High Rozenberg EP 0.05 mg E + P estradiol + dydrogerterone or estradiol + norethisterone Standar 1997 1 153 comb (see comment) Patch d EP 0.05 mg E + 0.17 estradiol + norethisterone acetate Standar 2 154 comb mg P Patch d EP 0.05 mg E + 0.35 estradiol + norethisterone acetate Standar 3 158 comb P Patch d 0.05 mg E + 0.17 estradiol + norethisterone acetate Standar 4 153 EP seq mg P Patch d 0.05 mg E + 0.35 estradiol + norethisterone acetate Standar 5 156 EP seq mg P Patch d Al -Azzawi estradiol Estraderm Standar 1997 1 129 Est 0.05 mg Patch d E-97 Ar Rout Est Generic Trade Study m N RxCat Dose e Dose estradiol Lyrelle 50 Standar 2 134 Est 0.05 mg Patch d 3 131 Est 0.08 mg Patch estradiol Lyrelle 80 High 123 EP 0.05 mg E + ? mg estradiol + progestogen Menorest + progestogen Standar Lubbert 1997 1 2 comb P Patch d 122 estradiol + progestogen Menorest + progestogen Standar 2 7 EP seq 0.05 mg + ? mg P Patch d Barentsen VayRi estradiol Estring 1997 1 83 Est 0.0075mg n Low VagC estriol Synapause 2 82 Est 0.5mg rm Low Bachmann EP VayRi estradiol + medroxyprogesterone Estring 1997 1 129 comb 0.0075mg n Low VagC conjugated equine estrogen Premarin Standar 2 67 Est 0.625 mg rm d conjugated equine estrogen Premarin Standar Good 1999 1 79 Est 0.625 mg Oral d 2 82 Est 1.25 mg Oral conjugated equine estrogen Premarin High estradiol Alora Standar 3 80 Est 0.05 mg Patch d 4 80 Est 0.1 mg Patch estradiol Alora High Mattsson estradiol + dydrogesterone Standar 2000 1 342 EP seq 2 mg E + 10 mg P Oral d 0.3 mg E + 10 mg NasS estradiol + dydrogesterone Aerodiol Standar 2 317 EP seq P pr d estradiol (E2) + desogestrel Liseta Standar Saure 2000 1 186 EP seq 1.5 mg E + 0.15 P Oral d estradiol valerate + Klimalet 2 190 EP seq 2 mg E + 10 mg P Oral medroxyprogesterone acetate High Graser 2000 1 199 EP 2 mg E + 2 mg P Oral estradiol valerate + dienogest Climodien High E-98 Ar Rout Est Generic Trade Study m N RxCat Dose e Dose comb EP estradiol valerate + dienogest 2 186 comb 2 mg E + 3 mg P Oral High EP 2 mg E + 1 mg estradiol + estriol + Kliogest Standar 3 196 comb Estriol + 1.0 mg P Oral norethisterone acetate d VagT estradiol Vagifem Rioux 2000 1 80 Est 0.025 mg ab Low VagC conjugated equine estrogen Premarin Standar 2 79 Est 1.25 mg rm d VagT estradiol Vagifem Dugal 2000 1 48 Est 0.025 mg ab Low VagP estriol Ovesterin 2 48 Est 0.5 mg es Low estradiol Climara UltraLo Parsey 2000 1 95 Est 0.025mg Patch w conjugated equine estrogen Premarin UltraLo 2 98 Est 0.3mg Oral w Meuwissen estradiol valerate + norgestrel Cyclocur 2001 1 314 EP seq 2mg E + 0.5mg P Oral High estradiol + trimegestone Standar 2 320 EP seq 2mg E + 0.5mg P Oral d 0.05 mg E + 10 or estradiol + dydrogesterone Estraderm + Standar Lopes 2001 1 185 EP seq 20 mg P Patch dydrogesterone d 0.3 mg E + 10 or NasS estradiol + dydrogesterone Aerodiol + Standar 2 176 EP seq 20 mg P pr dydrogesterone d estradiol + medroxyprogesterone acetate Standar Ozsoy 2002 1 100 EP seq 2 mg E + 5 mg P Oral d estradiol + medroxyprogesterone Aerodiol + 0.300 mg E + 5 NasS acetate medroxyprogesterone Standar 2 101 EP seq mg P pr acetate d E-99 Ar Rout Est Generic Trade Study m N RxCat Dose e Dose EP estradiol + norethisterone acetate Loh 2002 1 48 comb 1mg E + 0.5mg P Oral Low EP estradiol + norethisterone acetate Standar 2 48 comb 2mg E + 1mg P Oral d Buckler (d) estradiol + norethisterone Elleste Solo + Micronor- 2003 1 75 EP seq 1 mg E + 1 mg P Oral HRT Low 0.05 mg E + 1 mg VayRi estradiol acetate + Menoring + Micronor- 2 84 EP seq P n norethisterone HRT High EP esterified estrogens Estratab Standar Lobo 2003 1 111 comb 0.625 mg Oral d ET 0.625 mg E + esterified estrogens + Estratest-HS Standar 2 107 comb 1.25 mg T Oral methyltestosterone d Pornel 2005 1 387 EP seq 1 mg E + 0.25 P Oral estradiol + trimegestone Totelle Low estradiol valerate + Climagest Standar 2 377 EP seq 1 mg E + 1 mg P Oral norethisterone d Gambacciani EP 1 mg E + 0.125 estradiol + trimegestone 2005 1 432 comb mg P Oral Low EP 1 mg E + 0.5 mg estradiol + norethisterone 2 242 comb P Oral Low EP estradiol + norethisterone Standar 3 176 comb 2 mg E + 1 mg P Oral d EP estradiol acetate + progestin Femtrace Standar Utian 2005 1 79 comb 0.9 mg Oral d EP conjugated equine estrogens + Premarin Standar 2 85 comb 0.625 mg Oral progestin d EP estradiol + progestin Estrace 3 84 comb 1 mg Oral Low estradiol Estraderm Standar Davis 2005 1 60 Est 0.05 mg Patch d 2 60 Est 0.30 mg NasS estradiol Aerodiol Standar E-100 Ar Rout Est Generic Trade Study m N RxCat Dose e Dose pr d Raynaud 0.05 mg + 1.2mg estradiol + norethisterone Oesclim + Milligynon Standar 2005 1 136 EP seq P Patch acetate d 0.04 mg + 1.2mg estradiol + norethisterone Estrapatch + Milligynon 2 134 EP seq P Patch acetate Low 0.06 mg E + 1.2m estradiol + norethisterone Estrapatch + Milligynon 3 135 EP seq P Patch acetate High Braunstein 2005 1 119 Est Patch ET ? mg E + 0.15 mg estrogen + testosterone 2 106 comb T Patch ET ? mg E + 0.3 mg estrogen + testosterone 3 110 comb T Patch ET ? mg E + 0.45 mg estrogen + testosterone 4 111 comb T Patch Simon 2005 1 279 Est Patch 2 283 Test 0.3 mg Patch testosterone Weisberg VayRi estradiol ESTring 2005 1 126 Est 0.008mg n Low VagT estradiol Vagifem 2 59 Est 0.025mg ab Low Buster 2005 1 266 Est Patch 2 266 Test 0.3 mg Patch testosterone conjugated equine estrogen + Premarin + MPA EP 0.625 mg E + 2.5 depomedroxyprogesterone Standar Akhila 2006 1 35 comb mg P Oral acetate d estradiol + Estrogel + MPA EP 1.5 mg E + 2.5 SknG depomedroxyprogesterone Standar 2 25 comb mg P el acetate d 3 28 EP 0.05 mg E + 2.5 Patch estradiol + Estraderm + MPA Standar E-101 Ar Rout Est Generic Trade Study m N RxCat Dose e Dose comb mg P depomedroxyprogesterone d acetate conjugated estrogens + Premarin + 0.625 mg E + 10 medroxyprogesterone acetate medroxyprogesterone Standar Serrano 2006 1 55 EP seq mg P Oral acetate d estradiol + medroxyprogesterone Climara + 0.05 mg + 10 mg acetate medroxyprogesterone Standar 2 59 EP seq P Patch acetate d Cieraad 2006 1 98 EP seq 1 mg E + 10 mg P Oral estradiol + dydrogesterone Low 0.625 mg E + conjugated equine estrogens + norgestrel Standar 2 91 EP seq 0.15 mg P Oral d Davis 2006 1 39 Est Patch ET 2 37 comb ?mg E + 0.3 mg T Patch conjugated equine estrogen Standar Long 2006 1 37 Est 0.625mg Oral d 0.625mg/1g VagC conjugated equine estrogen Premarin Standar 2 36 Est cream rm d EP Shifren 2006 1 273 comb ?mg E Patch ET testosterone 2 276 comb ?mg E + 0.3 mg T Patch Limpaphayom EP 0.3 mg E + 1.5 conjugated estrogens + medroxyprogesterone acetate UltraLo (m) 2006 1 342 comb mg P Oral w EP 0.45 mg E + 1.5 conjugated estrogens + medroxyprogesterone acetate 2 342 comb mg P Oral Low EP 0.625 mg E + 2.5 conjugated estrogens + medroxyprogesterone acetate Standar 3 344 comb mg P Oral d EP 0.3mg E + 90mg NasS estradiol + progesterone Aerodiol + Crinone Standar Odabasi 2007 1 32 comb P pr d E-102 Ar Rout Est Generic Trade Study m N RxCat Dose e Dose EP 0.050mg E + estradiol + progesterone Climara + Crinone Standar 2 29 comb 90mg P Patch d Pitkin (d) EP 1 mg E + 2.5 mg estradiol valerate (E2V) + medroxyprogesterone acetate Standar 2007 1 152 comb P Oral (MPA) d EP estradiol valerate (E2V) + medroxyprogesterone acetate Standar 2 153 comb 1 mg E + 5 mg P Oral (MPA) d EP estradiol valerate (E2V) + medroxyprogesterone acetate 3 154 comb 2 mg E + 5 mg P Oral (MPA) High Penteado EP 0.625 mg E + 2.5 conjugated equine estrogens + medroxyprogesterone Standar 2008 1 27 comb mg P Oral acetate d ET 0.625 mg E + 2.5 conjugated equine estrogens + medroxyprogesterone Standar 2 29 comb mg P + 2.0 mg T Oral acetate + methyltestosterone d Panay 2010 1 142 Est Patch ET 2 130 comb 0.30 mg Patch (d): duplicate patient population with other included article; EP comb: estrogen plus progestin combined; EP seq: estrogen plus progestin sequential; Est: estrogen alone; ET comb: estrogen plus testosterone combine; (m): trial contains data from multiple publications; NasSpr: nasal spray; RxCat: treatment category; SknGel: skin gel; VagCrm: vaginal cream; VagOvu: vaginal ovule; VagPes: vaginal pessary; VagRin: vaginal ring; VagTab: vaginal tablet E-103 .
Recommended publications
  • PRESCRIBING INFORMATION OGEN* (Estropipate) Tablets 0.75 Mg, 1.5
    PRESCRIBING INFORMATION OGEN* (estropipate) Tablets 0.75 mg, 1.5 mg, 3.0 mg Estrogen Pfizer Canada Inc. Date of Revision: 17,300 Trans-Canada Highway 25 May 2009 Kirkland, Quebec, H9J 2M5 Control No. 120830 * TM Pharmacia Enterprises S.A. Pfizer Canada Inc., licensee © Pfizer Canada Inc., 2009 OGEN* (estropipate) Prescribing Information Page 1 of 27 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS..................................................................................................11 CLINICAL TRIAL ADVERSE DRUG REACTIONS.....................................................13 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION..............................................................................15 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................16
    [Show full text]
  • Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals
    Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment.
    [Show full text]
  • Classification and Pharmacology of Progestins
    Maturitas 46S1 (2003) S7–S16 Classification and pharmacology of progestins Adolf E. Schindler a,∗, Carlo Campagnoli b, René Druckmann c, Johannes Huber d, Jorge R. Pasqualini e, Karl W. Schweppe f, Jos H. H. Thijssen g a Institut für Medizinische Forschung und Fortbildung, Universitätsklinikum, Hufelandstr. 55, Essen 45147, Germany b Ospedale Ginecologico St. Anna, Corso Spezia 60, 10126 Torino, Italy c Ameno-Menopause-Center, 12, Rue de France, 06000 Nice, France d Abt. für Gynäkologische Endokrinologie, AKH Wien, Währingergürtel 18-20, 1090 Wien, Austria e Institute de Puériculture26, Boulevard Brune, 75014 Paris, France f Abt. für Gynäkologie und Geburtshilfe, Ammerland Klinik, Langestr.38, 26622 Westerstede, Germany g Department of Endocrinology, Universitair Medisch Centrum Utrecht, P.O. Box 85090, 3508 AB Utrecht, The Netherlands Abstract Besides the natural progestin, progesterone, there are different classes of progestins, such as retroprogesterone (i.e. dydroges- terone), progesterone derivatives (i.e. medrogestone) 17␣-hydroxyprogesterone derivatives (i.e. chlormadinone acetate, cypro- terone acetate, medroxyprogesterone acetate, megestrol acetate), 19-norprogesterone derivatives (i.e. nomegestrol, promege- stone, trimegestone, nesterone), 19-nortestosterone derivatives norethisterone (NET), lynestrenol, levonorgestrel, desogestrel, gestodene, norgestimate, dienogest) and spironolactone derivatives (i.e. drospirenone). Some of the synthetic progestins are prodrugs, which need to be metabolized to become active compounds. Besides
    [Show full text]
  • The Reactivity of Human and Equine Estrogen Quinones Towards Purine Nucleosides
    S S symmetry Article The Reactivity of Human and Equine Estrogen Quinones towards Purine Nucleosides Zsolt Benedek †, Peter Girnt † and Julianna Olah * Department of Inorganic and Analytical Chemistry, Budapest University of Technology and Economics, Szent Gellért tér 4, H-1111 Budapest, Hungary; [email protected] (Z.B.); [email protected] (P.G.) * Correspondence: [email protected] † These authors contributed equally to this work. Abstract: Conjugated estrogen medicines, which are produced from the urine of pregnant mares for the purpose of menopausal hormone replacement therapy (HRT), contain the sulfate conjugates of estrone, equilin, and equilenin in varying proportions. The latter three steroid sex hormones are highly similar in molecular structure as they only differ in the degree of unsaturation of the sterane ring “B”: the cyclohexene ring in estrone (which is naturally present in both humans and horses) is replaced by more symmetrical cyclohexadiene and benzene rings in the horse-specific (“equine”) hormones equilin and equilenin, respectively. Though the structure of ring “B” has only moderate influence on the estrogenic activity desired in HRT, it might still significantly affect the reactivity in potential carcinogenic pathways. In the present theoretical study, we focus on the interaction of estrogen orthoquinones, formed upon metabolic oxidation of estrogens in breast cells with purine nucleosides. This multistep process results in a purine base loss in the DNA chain (depurination) and the formation of a “depurinating adduct” from the quinone and the base. The point mutations induced in this manner are suggested to manifest in breast cancer development in the long run.
    [Show full text]
  • How to Select Pharmacologic Treatments to Manage Recidivism Risk in Sex Off Enders
    How to select pharmacologic treatments to manage recidivism risk in sex off enders Consider patient factors when choosing off -label hormonal and nonhormonal agents ® Dowden Healthex offenders Media traditionally are managed by the criminal justice system, but psychiatrists are fre- Squently called on to assess and treat these indi- CopyrightFor personalviduals. use Part only of the reason is the overlap of paraphilias (disorders of sexual preference) and sexual offending. Many sexual offenders do not meet DSM criteria for paraphilias,1 however, and individuals with paraphil- ias do not necessarily commit offenses or come into contact with the legal system. As clinicians, we may need to assess and treat a wide range of sexual issues, from persons with paraphilias who are self-referred and have no legal involvement, to recurrent sexual offenders who are at a high risk of repeat offending. Successfully managing sex offenders includes psychological and pharmacologic interven- 2009 © CORBIS / TIM PANNELL 2009 © CORBIS / tions and possibly incarceration and post-incarceration Bradley D. Booth, MD surveillance. This article focuses on pharmacologic in- Assistant professor terventions for male sexual offenders. Department of psychiatry Director of education Integrated Forensics Program University of Ottawa Reducing sexual drive Ottawa, ON, Canada Sex offending likely is the result of a complex inter- play of environment and psychological and biologic factors. The biology of sexual function provides nu- merous targets for pharmacologic intervention, in- cluding:2 • endocrine factors, such as testosterone • neurotransmitters, such as serotonin. The use of pharmacologic treatments for sex of- fenders is off-label, and evidence is limited. In general, Current Psychiatry 60 October 2009 pharmacologic treatments are geared toward reducing For mass reproduction, content licensing and permissions contact Dowden Health Media.
    [Show full text]
  • Bazedoxifene–Conjugated Estrogens for Treating Endometriosis Endometriosis: Nina S
    Endometriosis: Case Report Bazedoxifene–Conjugated Estrogens Teaching Points for Treating Endometriosis 1. The estrogen receptor (ER) is a definitive down- stream target in endometriosis. As an endometrial ER antagonist, bazedoxifene assures not only block- Valerie A. Flores, MD, ade of estrogen binding, but it also has the ability to Nina S. Stachenfeld, PhD, degrade the receptor. This unique property of baze- and Hugh S. Taylor, MD doxifene blocks estrogen action and makes it an attractive treatment option for endometriosis. 2. Conjugated estrogens paired with bazedoxifene do BACKGROUND: Endometriosis is a gynecologic disorder not require a progestin to block endometrial affecting 6–10% of reproductive-aged women. First-line growth, thus avoiding the side effects associated therapies are progestin-based regimens; however, failure with progestin-based regimens. 08/19/2018 on BhDMf5ePHKbH4TTImqenVGLGjjqParD6K7Nl5tTGGFqgjMmLRmuIlIgbkUbgVXoQ by http://journals.lww.com/greenjournal from Downloaded rates are high, often requiring alternative hormonal agents, each with unfavorable side effects. Bazedoxifene with con- ’ 1 Downloaded that can have a significant effect on patients lives. jugated estrogens is approved for treatment of menopausal Treatment consists of agents that induce atrophy of symptoms, and use in animal studies has demonstrated from regression of endometriotic lesions. As such, it represents endometriotic lesions. There is tremendous need for http://journals.lww.com/greenjournal a potential treatment option for endometriosis. therapies that are effective, have favorable side effect profiles, and can be used long term in women with CASE: A patient with stage III endometriosis referred for symptomatic endometriosis, especially for those not management of dysmenorrhea and cyclic pelvic pain was treated with 20 mg bazedoxifene and 0.45 mg conjugated responding to progestin-based regimens.
    [Show full text]
  • Full Text Pdf
    Eastern Biologist No. 4 2015 Protective Effects of Conjugated Equine Estrogens and 17-β Estradiol on Oxidatively Stressed Astrocytes Whitley E. Grimes and Kathleen S. Hughes The Eastern Biologist . ♦ A peer-reviewed journal that publishes original articles focused on the many diverse disciplines of biological research, except for the natural history science disciplines (ISSN 2165-6657 [online]). ♦ Subject areas - The journal welcomes manuscripts based on original research and observations, as well as research summaries and general interest articles. Subject areas include, but are not limited to, biochemistry, biotechnology, cell biology, developmental biology, genetics and genomics, immunology, microbiology, molecular evolution, neurobiology, parasitology, physiology, toxicology, as well as scientific pedagogy. ♦ Offers article-by-article online publication for prompt distribution to a global audience ♦ Offers authors the option of publishing large files such as data tables, audio and video clips, and even PowerPoint presentations as online supplemental files. ♦ Special issues - The Eastern Biologist welcomes proposals for special issues that are based on conference proceedings or on a series of invitational articles. Special issue editors can rely on the publisher’s years of experiences in efficiently handling most details relating to the publication of special issues. ♦ Indexing - As is the case with Eagle Hill's other journals, the Eastern Biologist is expected to be fully indexed in Elsevier, Thomson Reuters, Proquest, EBSCO, Google Scholar, and other databases. ♦ The journal staff is pleased to discuss ideas for manuscripts and to assist during all stages of manuscript preparation. The journal has a mandatory page charge to help defray a portion of the costs of publishing the manuscript.
    [Show full text]
  • Estradiol Acetate Vaginal Ring) Rx Only
    NDA 21-367/S-002 Page 3 PRESCRIBING INFORMATION Femring® (estradiol acetate vaginal ring) Rx Only ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.) CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS, Cardiovascular disorders and Dementia.) The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.) The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens
    [Show full text]
  • Failures and Controversies of the Antiestrogen Treatment of Breast Cancer
    In: Estrogen Prevention for Breast Cancer ISBN: 978-1-62417-378-3 Editor: Zsuzsanna Suba © 2013 Nova Science Publishers, Inc. No part of this digital document may be reproduced, stored in a retrieval system or transmitted commercially in any form or by any means. The publisher has taken reasonable care in the preparation of this digital document, but makes no expressed or implied warranty of any kind and assumes no responsibility for any errors or omissions. No liability is assumed for incidental or consequential damages in connection with or arising out of information contained herein. This digital document is sold with the clear understanding that the publisher is not engaged in rendering legal, medical or any other professional services. Chapter VII Failures and Controversies of the Antiestrogen Treatment of Breast Cancer Zsuzsanna Suba National Institute of Oncology, Department of Surgical and Molecular Pathology, Budapest, Hungary Abstract In postmenopausal women, estrogens have unquestionable preventive and curative effects against atherogenic cardiovascular lesions, osteoporosis and neurodegenerative diseases. Moreover, recent studies on correlations between hormone replacement therapy and cancer risk could justify preventive, anticancer capacities of estrogen both on smoking associated and hormone related cancers. Experimental developing of antiestrogen compounds aimed to inhibit the binding of presumably harmful, endogenous estrogen to its receptor system so as to achieve a regression of hormone-related cancers. However, antiestrogens proved to be ineffective in the majority of selected receptor positive breast cancer cases and produced severe side effects, such as vascular complications and cancer development at several sites. Failure of antiestrogen therapy was designated as ―endocrine resistance‖ of tumors.
    [Show full text]
  • Estrogen Agents, Oral-Transdermal
    GEORGIA MEDICAID FEE-FOR-SERVICE ESTROGEN AGENTS, ORAL - TRANSDERMAL PA SUMMARY Preferred Non-Preferred Oral Estrogens Estradiol generic n/a Menest (esterified estrogens) Premarin (estrogens, conjugated) Oral Estrogen/Progestin Combinations Angeliq (drospirenone/estradiol) Bijuva (estradiol/progesterone) Estradiol/norethindrone and all generics for Activella Norethindrone/ethinyl estradiol and all generics for Femhrt Low Dose 0.5/2.5 (norethindrone/ethinyl Femhrt Low Dose estradiol) Jinteli and all generics for Femhrt 1/5 (norethindrone/ethinyl estradiol) Prefest (estradiol/norgestimate) Premphase (conjugated estrogens/medroxyprogesterone) Prempro (conjugated estrogens/medroxyprogesterone) Topical Estrogens Alora (estradiol transdermal patch) Divigel (estradiol topical gel) Estradiol transdermal patch (generic Climara) Elestrin (estradiol topical gel) Evamist (estradiol topical spray solution) Estradiol transdermal patch (generic Vivelle-Dot) Menostar (estradiol transdermal patch) Minivelle (estradiol transdermal patch) Vivelle-Dot (estradiol transdermal patch) Topical Estrogens/Progestin Combination Climara Pro (estradiol/levonorgestrel transdermal patch) n/a Combipatch (estradiol/norethindrone transdermal patch) Oral Selective Estrogen Receptor Modulator (SERMs) Raloxifene generic Duavee (conjugated estrogens/bazedoxifene) Osphena (ospemifene) LENGTH OF AUTHORIZATION: 1 year PA CRITERIA: Bijuva ❖ Approvable for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus who have experienced inadequate response, allergies, contraindications, drug-drug interactions or intolerable side effects to at least two preferred oral estrogen/progestin combination products. Revised 6/29/2020 Norethindrone/Ethinyl Estradiol and All Generics for Femhrt Low Dose ❖ Prescriber must submit a written letter of medical necessity stating the reasons at least two preferred oral estrogen/progestin combination products, one of which must be brand Femhrt Low Dose, are not appropriate for the member.
    [Show full text]
  • Pp375-430-Annex 1.Qxd
    ANNEX 1 CHEMICAL AND PHYSICAL DATA ON COMPOUNDS USED IN COMBINED ESTROGEN–PROGESTOGEN CONTRACEPTIVES AND HORMONAL MENOPAUSAL THERAPY Annex 1 describes the chemical and physical data, technical products, trends in produc- tion by region and uses of estrogens and progestogens in combined estrogen–progestogen contraceptives and hormonal menopausal therapy. Estrogens and progestogens are listed separately in alphabetical order. Trade names for these compounds alone and in combination are given in Annexes 2–4. Sales are listed according to the regions designated by WHO. These are: Africa: Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Democratic Republic of the Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, South Africa, Swaziland, Togo, Uganda, United Republic of Tanzania, Zambia and Zimbabwe America (North): Canada, Central America (Antigua and Barbuda, Bahamas, Barbados, Belize, Costa Rica, Cuba, Dominica, El Salvador, Grenada, Guatemala, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama, Puerto Rico, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago), United States of America America (South): Argentina, Bolivia, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Guyana, Paraguay,
    [Show full text]
  • Determination of 17 Hormone Residues in Milk by Ultra-High-Performance Liquid Chromatography and Triple Quadrupole Mass Spectrom
    No. LCMSMS-065E Liquid Chromatography Mass Spectrometry Determination of 17 Hormone Residues in Milk by Ultra-High-Performance Liquid Chromatography and Triple Quadrupole No. LCMSMS-65E Mass Spectrometry This application news presents a method for the determination of 17 hormone residues in milk using Shimadzu Ultra-High-Performance Liquid Chromatograph (UHPLC) LC-30A and Triple Quadrupole Mass Spectrometer LCMS- 8040. After sample pretreatment, the compounds in the milk matrix were separated using UPLC LC-30A and analyzed via Triple Quadrupole Mass Spectrometer LCMS-8040. All 17 hormones displayed good linearity within their respective concentration range, with correlation coefficient in the range of 0.9974 and 0.9999. The RSD% of retention time and peak area of 17 hormones at the low-, mid- and high- concentrations were in the range of 0.0102-0.161% and 0.563-6.55% respectively, indicating good instrument precision. Method validation was conducted and the matrix spike recovery of milk ranged between 61.00-110.9%. The limit of quantitation was 0.14-0.975 g/kg, and it meets the requirement for detection of hormones in milk. Keywords: Hormones; Milk; Solid phase extraction; Ultra performance liquid chromatograph; Triple quadrupole mass spectrometry ■ Introduction Since 2008’s melamine-tainted milk scandal, the With reference to China’s national standard GB/T adulteration of milk powder has become a major 21981-2008 "Hormone Multi-Residue Detection food safety concern. In recent years, another case of Method for Animal-derived Food - LC-MS Method", dairy product safety is suspected to cause "infant a method utilizing solid phase extraction, ultra- sexual precocity" (also known as precocious puberty) performance liquid chromatography and triple and has become another major issue challenging the quadrupole mass spectrometry was developed for dairy industry in China.
    [Show full text]