Methods of Family Planning Based on Autoobservation and Self-Evaluation of the Ovarian Cycle
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Levosert 20Microgram/24 Hours Intrauterine Delivery System UK/H/3030/001/DC
PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC Public Assessment Report Decentralised Procedure LEVOSERT 20MICROGRAM/24 HOURS INTRAUTERINE DELIVERY SYSTEM (levonorgestrel) Procedure No: UK/H/3030/001/DC UK Licence No: PL 30306/0438 ACTAVIS GROUP PTC ehf 1 PAR Levosert 20microgram/24 hours Intrauterine Delivery System UK/H/3030/001/DC LAY SUMMARY Levosert 20 microgram/24 hours Intrauterine Delivery System (levonorgestrel, intrauterine delivery system, 52mg (20 micrograms/24 hours)) This is a summary of the Public Assessment Report (PAR) for Levosert 20 microgram/24 hours Intrauterine Delivery System (PL 30306/0438; UK/H/3030/001/DC, previously PL 34096/0003; UK/H/3030/001/DC). It explains how Levosert 20 microgram/24 hours Intrauterine Delivery System was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Levosert 20 microgram/24 hours Intrauterine Delivery System. For practical information about using Levosert 20 microgram/24 hours Intrauterine Delivery System, patients should read the package leaflet or contact their doctor or pharmacist. Levosert 20 microgram/24 hours Intrauterine Delivery System may be referred to as Levosert in this report. What is Levosert and what is it used for? Levosert is an intrauterine delivery system (IUS) for insertion in the womb. It can be used in the following ways: • as an effective method of contraception (prevention of pregnancy); • for heavy menstrual bleeding (heavy periods). Levosert is also useful for reducing menstrual blood flow, so it can be used if you suffer from heavy menstrual bleeding (periods). -
F.8 Ethinylestradiol-Etonogestrel.Pdf
General Items 1. Summary statement of the proposal for inclusion, change or deletion. Here within, please find the evidence to support the inclusion Ethinylestradiol/Etonogestrel Vaginal Ring in the World Health Organization’s Essential Medicines List (EML). Unintended pregnancy is regarded as a serious public health issue both in developed and developing countries and has received growing research and policy attention during last few decades (1). It is a major global concern due to its association with adverse physical, mental, social and economic outcomes. Developing countries account for approximately 99% of the global maternal deaths in 2015, with sub-Saharan Africa alone accounting for roughly 66% (2). Even though the incidence of unintended pregnancy has declined globally in the past decade, the rate of unintended pregnancy remains high, particularly in developing regions. (3) Regarding the use of contraceptive vaginal rings, updated bibliography (4,5,6) states that contraceptive vaginal rings (CVR) offer an effective contraceptive option, expanding the available choices of hormonal contraception. Ethinylestradiol/Etonogestrel Vaginal Ring is a non-biodegradable, flexible, transparent with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Ethinylestradiol/Etonogestrel Vaginal Ring is intended for women of fertile age. The safety and efficacy have been established in women aged 18 to 40 years. The main advantages of CVRs are their effectiveness (similar or slightly better than the pill), ease of use without the need of remembering a daily routine, user ability to control initiation and discontinuation, nearly constant release rate allowing for lower doses, greater bioavailability and good cycle control with the combined ring, in comparison with oral contraceptives. -
Farr Handouts
4/14/2021 Recent Pharmacological & Faculty Therapeutic Developments in Women’s Health Glen E. Farr, PharmD Professor Emeritus of Clinical Satellite Conference and Live Webcast Pharmacy and Translational Science April 16, 2021 University of Tennessee 9:00 – 12:00 p.m. Central Time College of Pharmacy [email protected] Produced by the Alabama Department of Public Health Video Communications and Distance Learning Division Educational Objectives Still Have • Outline the recent developments, Sugar & guidelines and/or recommendations Spice for pharmacological management of women’s health conditions, with a focus on contraception. • Identify essential information to counsel patients on the therapeutic application of these medications. Edi the Grand Dog’s first visit to our house 1 4/14/2021 2020 Drug Approvals FDA Annual Novel • 53 Novel agents approved Drug Approvals: – Historical previous 10 year average = 40 2011-2020 • 31 Orphan Drugs • 21 “First in Class” 59 53 48 45 46 • 17 Fast-track 39 41 30 • 22 Break-through 27 22 • 30 Priority review 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 • 12 Accelerated approval FDA.gov Faster FDA Drug Approvals: 3 Question Knowledge Good or Bad? Assessment on • Over the last 4 decades, the FDA has loosened its Contraception requirements for approving new drugs, increasingly accepting less data and more surrogate endpoints in clinical trials, and shortening its reviews. Is this good or bad? • From 1995 to 1997, 80.6% of new drugs were approved on the basis of two pivotal trials — but that number dropped to 52.8% from 2015 to 2017. A number of programs were enacted during the study period that led to faster approvals, such as fast track and the breakthrough therapy designation. -
Agile Patch (AG200-15) October 30, 2019 Agile Therapeutics, Inc
CO-1 Agile Patch (AG200-15) October 30, 2019 Agile Therapeutics, Inc. Bone, Reproductive, and Urologic Drugs Advisory Committee CO-2 Introduction Geoffrey Gilmore Senior Vice President Agile Therapeutics, Inc. CO-3 Need for More Contraceptive Options to Fit Individual Lifestyles, Evolving Needs . Unintended pregnancy: significant public health problem . Another transdermal system could provide women new, non-invasive method . Data show many women want a contraceptive patch1 . Only available patch delivers ~56 mcg of estrogen . Lower-dose patch benefits women seeking transdermal option Focus on approvability of Agile Patch as that new option 1. IMS National Prescription Audit CO-4 Key Topics for Discussion Topics Points to Consider • Varying definitions of low-dose estrogen 1. Low-dose CHC • Agile Patch delivers ~30 mcg daily of ethinyl estradiol (EE) • Only contraceptive patch available delivers ~56 mcg daily EE • FDA considers an unmet need in terms of serious conditions 2. Unmet Need • Contraception needs defined by gaps in options 3. Prespecified • Contraceptive trials not designed to meet a specific objective Criterion in • Study 23 designed to estimate Pearl Index, regulatory standard for Contraceptive Trials evaluating efficacy with tight confidence interval 4. Pearl Index: Upper • UB ≤ 5 based on historical contraceptive studies Bound of 95% CI • Limited utility for evaluating more contemporary trials, like Study 23 CO-5 Combination Hormonal Contraceptive (CHC) with Levonorgestrel (LNG) + Ethinyl Estradiol (EE) 28 cm2 < 1mm thick -
Thesis-1968-K45i.Pdf
INVESTIGATIONS ON THE VARIATIONS IN THE CRYSTAL PATTERNS OF CERVICAL AND NASAL MUCUS DURING THE ESTROUS CYCLE IN EWES Bvv BHUPALSINGH l\lIAHETAPSINGH KfL.\MAREu Bachelor O.Lh V(~ t' erinary. s cience. Uni.ve:rsi t;y of Saugar Sagar, Madhya Pradesh, India 1956 Submitted to the faculty of the Graduate College of the Oklahoma State University in partial f1J.lfillment of the requirements for the degree of TulASTER OF SCIENCE lvlay, 1968 OKlAHOMA STATE UNIVERSllY ; LIBRARY !· OCT 25 1968 INVESTIGATIONS ON THE VARIATIONS IN THE CH.YSTAL PATTERNS OF CERVICAL AND NASAL MUCUS DURING THE ESTROUS CYCLE IN EWES Thesis Approved: ./l1 o~te School 688438 ii ACKNOWLEDGMENTS The.author expresses his sincere gratitude to Drs. J. V. Whiteman and E. J. Turman, Professors of Animal Science, for their counsel and guidance during the course of this study and their valuable help in the preparation of this thesis. The author also expresses his sincere appreciation and gratefulness to devoted friends, Mr. and Mrs. George W. Varns, Edwardsport, Indiana, for their inspi~ations and encouragement during the entire course of this study. Grateful indebtedness is also extended to Mr. and Mrs. Ernest Miller, Bicknell, Indiana; Mr. and Mrs. Fred Buescher; Mr. and Mrs. Ollie Richardson, Edwardsport, Indiana; and Mr. Gottlieb Volle, Sandborn, Indiana, whose contributions to the scholarship fund made possible the graduate study of the author. The author is grateful for the privilege of association and assistance of fellow graduate students in the Department of Animal Science. iii TABLE OF CONTENTS Page INTRODUCTION ••••• • • • • • • • • • • • • • • • • • 1 REVIEW OF LITERATURE •• • • • • • • • • • • • • • • • • 3 The Phenomenon of Arborization in Relation to !Ylenstrual Cycle. -
Recent Advances in Hormonal Contraception HW Raymond Li1 and Richard a Anderson2*
Published: 09 August 2010 © 2010 Medicine Reports Ltd Recent advances in hormonal contraception HW Raymond Li1 and Richard A Anderson2* Addresses: 1Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, People’s Republic of China; 2Division of Reproductive and Developmental Sciences, The University of Edinburgh, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UK * Corresponding author: Richard A Anderson ([email protected]) F1000 Medicine Reports 2010, 2:58 (doi:10.3410/M2-58) This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/3.0/legalcode), which permits unrestricted use, distribution, and reproduction in any medium, for non-commercial purposes provided the original work is properly cited. You may not use this work for commercial purposes. The electronic version of this article is the complete one and can be found at: http://f1000.com/reports/medicine/content/2/58 Abstract This report reviews some of the new studies regarding new hormonal contraceptive formulations (e.g., Yaz, Qlaira®, extended-cycle or continuous combined contraceptives, subcutaneous depot medroxyprogesterone acetate, and ulipristal acetate as an emergency contraceptive). Recent data on the relationship between hormonal contraceptive use and bone health are also reviewed. Introduction and context better than, that of older COCs and has an acceptable Hormonal contraception is one of the most widely used bleeding pattern. Yaz is currently the only COC with contraceptive modalities and provides very good efficacy reported evidence for and approved indication in and low failure rates. -
Contraception - Update and Trends Rabe T J
Journal für Reproduktionsmedizin und Endokrinologie – Journal of Reproductive Medicine and Endocrinology – Andrologie • Embryologie & Biologie • Endokrinologie • Ethik & Recht • Genetik Gynäkologie • Kontrazeption • Psychosomatik • Reproduktionsmedizin • Urologie Contraception - Update and Trends Rabe T J. Reproduktionsmed. Endokrinol 2010; 7 (Sonderheft 1), 18-38 www.kup.at/repromedizin Online-Datenbank mit Autoren- und Stichwortsuche Offizielles Organ: AGRBM, BRZ, DVR, DGA, DGGEF, DGRM, D·I·R, EFA, OEGRM, SRBM/DGE Indexed in EMBASE/Excerpta Medica/Scopus Krause & Pachernegg GmbH, Verlag für Medizin und Wirtschaft, A-3003 Gablitz FERRING-Symposium digitaler DVR 2021 Mission possible – personalisierte Medizin in der Reproduktionsmedizin Was kann die personalisierte Kinderwunschbehandlung in der Praxis leisten? Freuen Sie sich auf eine spannende Diskussion auf Basis aktueller Studiendaten. SAVE THE DATE 02.10.2021 Programm 12.30 – 13.20Uhr Chair: Prof. Dr. med. univ. Georg Griesinger, M.Sc. 12:30 Begrüßung Prof. Dr. med. univ. Georg Griesinger, M.Sc. & Dr. Thomas Leiers 12:35 Sind Sie bereit für die nächste Generation rFSH? Im Gespräch Prof. Dr. med. univ. Georg Griesinger, Dr. med. David S. Sauer, Dr. med. Annette Bachmann 13:05 Die smarte Erfolgsformel: Value Based Healthcare Bianca Koens 13:15 Verleihung Frederik Paulsen Preis 2021 Wir freuen uns auf Sie! Contraception – Update and Trends Contraception – Update and Trends* T. Rabe Fertility control in the future will focus on the improvement of existing methods (efficacy, side effects, easy use, duration of action, manufacturing process, costs), on new approaches (mode of action) bringing additional health benefits, and on new targets for nonhormonal contraception. Counselling of women in view to contraceptive choices based on the individual risk (e. -
Examination and Processing of Human Semen
WHO laboratory manual for the Examination and processing of human semen FIFTH EDITION WHO laboratory manual for the Examination and processing of human semen FIFTH EDITION WHO Library Cataloguing-in-Publication Data WHO laboratory manual for the examination and processing of human semen - 5th ed. Previous editions had different title : WHO laboratory manual for the examination of human semen and sperm-cervical mucus interaction. 1.Semen - chemistry. 2.Semen - laboratory manuals. 3.Spermatozoa - laboratory manuals. 4.Sperm count. 5.Sperm-ovum interactions - laboratory manuals. 6.Laboratory techniques and procedures - standards. 7.Quality control. I.World Health Organization. ISBN 978 92 4 154778 9 (NLM classifi cation: QY 190) © World Health Organization 2010 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications— whether for sale or for noncommercial distribution—should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expres- sion of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specifi c companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. -
Cervical Mucus: an Agent Or a Barrier to Conception?
CERVICAL MUCUS: AN AGENT OR A BARRIER TO CONCEPTION? EILEEN LINFORD Ministry ofAgriculture, Fisheries and Food, Cattle Breeding Centre, Shinfield, Reading RG2 9BZ The significance of the cervix and its secretion, in relation to conception, varies with the species. By natural service, semen deposition in the pig and horse is intrauterine. This is also the site of artificial insemination in cattle even though the semen is deposited in the vagina at natural mating. In these species, therefore, the cervix is by-passed and the cervical mucus can be used only indirectly as an indicator of the stage of the cycle or of the hormonal state of the female. In contrast, in the sheep and in man the semen is deposited in the vagina. Further- more, human semen is deposited in the female tract at times other than when fertilization can occur. The cervix in these species is involved in the process of conception. The physical and chemical properties of the cervical mucus de- termine whether the spermatozoa penetrate the cervix and reach the site of fertilization and so the mucus in these species can act either as an agent or as a barrier to conception. The cervical mucus of most species shows cyclical changes in its physical and chemical properties; these changes are under hormonal control. Most studies of cervical mucus have been concerned with establishing the cyclical variation in mucous components. It is not my intention to present these qualitative and quantitative changes here since this information has already been satisfactorily reviewed (Gibbons & Mattner, 1966; Weiss, 1970; Schumacher, 1970, 1971; Davajan, Nakamura & Kharma, 1970; Moghissi & Blandau, 1972). -
Contraceptive Effectiveness and Obesity
Contraceptive Effectiveness and Obesity Diana Blithe, PhD Program Director for Contraceptive Development Contraception Research Branch Disclosures: NICHD has a Collaborative Research and Development Agreement (CRADA) with HRA Pharma (Paris, France). The goal of the CRADA is to develop Ulipristal Acetate (CDB-2914) for therapeutic indications. NICHD Principal Investigators: Diana Blithe, PhD & Lynnette Nieman, MD Types of Obesity – Benign vs At-risk • Healthy normal weight - BMI 18.5 - 24.9 kg/m2 0 - 1 metabolic syndrome component: 1) Triglycerides ≥150 mg/dl 2) HDL < 50 mg/dl and/or use of lipid-lowering medication 3) Glucose ≥100 mg/dl 4) Hypertension and/or use of anti-hypertensive medication • As of 2012, ~32% of reproductive age women are obese. Ogden CL et al. Prevalence of Childhood and Adult Obesity in the United States, 2011-2012 . JAMA. 2014;311:806-814 • Benign (Metabolically healthy) obesity - BMI ≥30 kg/m2 0 - 1 metabolic syndrome component (include in contraceptive clinical trials?) • At Risk (Unhealthy) obesity - BMI ≥30 kg/m2 ≥ 2 metabolic syndrome components (exclude from contraceptive clinical trials!) Bleil ME, et al. Pubertal Timing, Androgens, and Obesity Phenotypes in Women at Midlife. J Clin Endocrinol Metab. 2012 97: E1948–52 Midlife for women is age 25-45. Midlife for men? Risk of Venous Thromboembolism: with Hormonal Contraceptives containing Ethinyl Estradiol (EE), with Obesity or with Pregnancy R.R Incidence Young women in general population 1 1- 5 /10,000/y Use of COCs 2.5-5.5* 3-15 /10,000/y Low EE dose COC (BMI 20-25) 2 Low EE dose COC (BMI 30-35) 4 Low EE dose COC (BMI ≥35) 8 Pregnancy: Pregnant Women (BMI ≤25) 12 During Pregnancy 5-20 /10,000/y Post Partum 40-65 /10,000/y Pregnant Women (BMI ≥30) 30 May be a higher PE vs DVT rate in obese pregnant women *de Bastos M, et al . -
Emergency Contraception - Potential for Women’S Health
Review Article Indian J Med Res 140 (Supplement), November 2014, pp 45-52 Emergency contraception - Potential for women’s health Suneeta Mittal* Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, New Delhi, India Received April 12, 2013 Emergency contraception (EC) is a safe and effective method which is used to prevent unwanted pregnancy after unprotected sexual intercourse. Many of the unwanted pregnancies end in unsafe abortions. The search for an ideal contraceptive, which does not interfere with spontaneity or pleasure of the sexual act, yet effectively controls the fertility, is still continuing. Numerous contraceptive techniques are available, yet contraceptive coverage continues to be poor in India. Thus, even when not planning for a pregnancy, exposure to unprotected sex takes place often, necessitating the use of emergency contraception. This need may also arise due to failure of contraceptive method being used (condom rupture, diaphragm slippage, forgotten oral pills) or following sexual assault. Emergency contraception is an intervention that can prevent a large number of unwanted pregnancies resulting from failure of regular contraception or unplanned sexual activity, which in turn helps in reducing the maternal mortality and morbidity due to unsafe abortions. However, a concern has been expressed regarding repeated and indiscriminate usage of e-pill, currently the rational use of emergency contraception is being promoted as it is expected to make a significant dent in reducing the number of unwanted pregnancies and unsafe abortions. In fact, since the introduction of emergency contraception, the contribution of unsafe abortion towards maternal mortality has declined from 13 to 8 per cent. Key words Emergency contraception - IUD - levonorgestrel - pregnancy - unprotected sex - Yuzpe regimen Introduction signifies, it is meant only for contraceptive emergency situations and not for routine or repeated use. -
Pharmacology of Estrogens and Progestogens: Influence of Different Routes of Administration
CLIMACTERIC 2005;8(Suppl 1):3–63 Pharmacology of estrogens and progestogens: influence of different routes of administration H. Kuhl Department of Obstetrics and Gynecology, J. W. Goethe University of Frankfurt, Germany Key words: ESTROGENS, PROGESTOGENS, PHARMACOKINETICS, PHARMACODYNAMICS, HORMONE REPLACEMENT THERAPY ABSTRACT This review comprises the pharmacokinetics and pharmacodynamics of natural and synthetic estrogens and progestogens used in contraception and therapy, with special consideration of hormone replacement therapy. The paper describes the mechanisms of action, the relation between structure and hormonal activity, differences in hormonal pattern and potency, peculiarities in the properties of certain steroids, tissue-specific effects, and the metabolism of the available estrogens and progestogens. The influence of the route of administration on pharmacokinetics, hormonal activity and metabolism is presented, and the effects of oral and transdermal treatment with estrogens on tissues, clinical and serum parameters are compared. The effects of oral, transdermal (patch and gel), intranasal, sublingual, buccal, vaginal, subcutaneous and intramuscular adminis- tration of estrogens, as well as of oral, vaginal, transdermal, intranasal, buccal, intramuscular and intrauterine application of progestogens are discussed. The various types of progestogens, their receptor interaction, hormonal pattern and the hormonal activity of certain metabolites are described in detail. The structural formulae, serum concentrations, binding affinities to steroid receptors and serum binding globulins, and the relative potencies of the available estrogens and progestins are presented. Differences in the tissue-specific effects of the various compounds and regimens and their potential implications with the risks and benefits of hormone replacement therapy are discussed. INTRODUCTION The aim of any hormonal treatment of postmen- tance of pharmacological knowledge for an opausal women is not to restore the physiological optimal use of hormone therapy.