What s new with contraception?

Transcription

1 Disclosure Information What s new with contraception? Paula M. Castaño, MD, MPH Assistant Professor of OB/GYN at Columbia University Medical Center MN Reproductive and Sexual Health Update 9 September 2014 Bayer Research support (Mirena) Trainer (Essure) Merck Trainer (Nexplanon) Learning Objectives Know where to find resources for the latest contraception information Distinguish between different options available for emergency contraception (EC) Understand the mechanism of action, effectiveness, and safety of EC Understand the role of obesity in decisions regarding EC Have heard any late-breaking news in the world of contraception 1

2 Contraception Resources CDC MEC, CDC SPR,

3 US Selected Practice Recommendations CDC MEC ( Who can use contraceptives ) companion How to use contraceptives Initiation timing, back-up, special considerations, exams/tests needed, F/U, management of side effects Key SPR Appendix C Exams/tests needed before contraceptive initiation Blood pressure measurement only before OCPs Bimanual exam only before diaphragm, cervical cap, IUD Appendix E Management of bleeding irregularities while using contraception NSAIDs X 5-7 days, OCPs or estrogen Appendix F Management of IUD with PID Treat per CDC guidelines and reassess in 48-72hr Advise condom use for protection LARC Resources The Journal of Adolescent Health LARC Supplement available at: CHOICE Project, CHOICE Project Nearly 10,000 women receiving free contraceptive counseling and provision in St. Louis 34% chose implant, 30% Mirena LNG IUS, 13% OCPs, 10% injectable, 5% ring, 5% Cu IUD, 2% patch 3

4 CHOICE Project Winner 2012, Peipert 2012; Pazol 2013; O Neil- Callahan mo continuation: 81% LARC vs. 44% non-larc 24mo : 77% vs 41% Satisfaction: 75% LARC vs. 42% non-larc Pill/patch/ring users 20X more likely to have unintended pregnancy Risk of unintended pregnancy 2X higher in <21yo Abortion rates in CHOICE 4-8/1, /1,000 St. Louis region, 15/1,000 in US Adolescent birth rate in CHOICE dropped to 6/1,000! (vs. 27/1,000 in US) EC Why? YRBS MMWR 61(4); Hou 2010 Unprotected sex happens 11% used no contraceptive last sex Contraceptive misuse Up to 5 missed pills per cycle Less effective methods of contraception are frequently used Current Contraceptive Use Method Current Use by 15-44yo (2010) Sterilization (F + M) 37% Pill 28% Male condom 16% IUD 6% Withdrawal 5% Injectable 4% Vaginal ring 2% Patch 1% Implant 1% Fertility awareness 1% Other 1% 4

5 Trussell 2011 Use and Effectiveness Method Current Use by 15-44yo, % (2010) Typical Use Failure Rate (%) Sterilization (F + M) Pill 28 9 Male condom IUD Withdrawal 5 22 Injectable 4 6 Vaginal ring, patch 3 9 Implant Fertility awareness 1 22 Other 1 varies EC What? Copper IUD 99%+ effective Up to 5 days Effective contraception 10+ years Best option for obese women EC What? Ulipristal acetate, UPA, Ella Since mg Selective progesterone receptor modulator antiprogestin properties 98-99% effective Within 120 hours Indication for symptomatic fibroids in Europe EC What? Levonorgestrel (Plan B One-step, Take Action, Next Choice One Dose, My Way) 1.5mg OTC without age restrictions for women and men 72hr labeling Most effective time frame 5

6 EC What? Yuzpe regimen Ethinyl estradiol + levonorgestrel combination Least effective Most side effects /questions/dose.html# dose EC How? Cu IUD Copper inhibits sperm motility and viability May also act after fertilization to prevent implantation EC How? UPA Inhibition or delay of ovulation may be only mechanism of action Can delay follicular rupture for 5 days EC How? LNG Inhibits ovulation Ineffective after onset of LH surge Can shorten luteal phase No effect on cervical mucus or sperm Does not alter endometrium 6

7 McKay 2014 EC Window of Opportunity EC - Safety Safer than pregnancy Not teratogenic Short duration of exposure and low total hormone content For IUD, screen for STI at insertion per CDC recommendations Per CDC MEC Category 1 or 2 for all medical conditions (including migraines, liver disease, cardiovascular disease, h/o ectopic, breastfeeding) EC - Effectiveness EC - Effectiveness Pregnancies /1000 women after unprotected intercourse 25 Pregnancies expected per 1000 women who had unprotected sex in last 3 days Paragard IUD Ella pills Levonorgestrel Yuzpe Cu IUD, UPA, LNG, Yuzpe, Nothing 7

8 EC - Obesity ECP failure among obese (BMI 30kg/m 2 ) versus normal or underweight women (<25kg/m 2 ) LNG: OR = 4.4 Ulipristal: OR = 2.6 LNG appeared not effective at BMI of 26kg/m 2 UPA appeared not effective at BMI 35kg/m 2 Pregnancy risk higher if intercourse day before ovulation (OR 4.4) and after EC (OR 4.6) Glasier A et al. Contraception UPA Access/Supply Joanne Collison jcollison@rsnortheast.com Ext 3116 Fax: After EC? Ongoing contraception QuickStart OK after LNG-EC All QS studies used EC liberally Results reassuring More EC No data on QS after UPA Per SPR, any method can be started immediately with backup X 14days 8

9 Cu IUD Can be inserted >5 days after sex if not >5 days after ovulation Advance provision EC allows a patient to take as soon as possible Routine antiemetics are not recommended Redose if emesis within 3 hours EC Summary McKay 2014 Take-away EC Points IUD is most effective EC option Especially with repeated unprotected intercourse with obesity 9

10 Colorado Family Planning Initiative $23 million commitment ,000 LARC provided at low/no cost at FP clinics LARC use increased 4-fold Adolescent birth rate decreased 40% Adolescent abortion rate decreased 35% WIC enrollment decreased 23% $42.5 million health care expenditures saving to Colorado Raymond 2014 CHOICE Substudies Levonorgestrel Intrauterine System for EC (LIFE) LNG IUS vs. LNG EC within 120hr 6mo F/U Effectiveness of Prolonged Use of IUD/Implant for Contraception (EPIC) LNG IUS or contraceptive implant past the FDA-approved duration Where are we going? On-demand Oral Contraception (Raymond, Gynuity Health Projects) Precursor to EC, LNG 0.75mg To be used post-coitally, best for infrequent sex 58% of US women surveyed would be interested in use Perceived advantages: ease of remembering, infrequent sex, PRN use, control 5-22 pregnancies/100 woman-years 10

11 Where are we going - OCPs? Innovations to decrease risk (e.g., VTE) OTC OCs should be available OTC Women should self-screen for contraindications Cost concerns exist Pap/STI screening not medically required for initiation Continuation higher with more packs provided Ulipristal acetate for contraception (NICHD) Where are we going? Nestorone/EE vaginal ring same ring for 13 cycles Non-androgenic progestin Population Council -> NDA FDA Nestorone/E2 vaginal ring 3-month ring Lower potency estrogen Progestin-only ring Progering - marketed in Latin America for lactating women UPA ring (Population Council; Jensen Contraception 2013) Levonorgestrel (progestin-only) patch Where are we going? Longer-acting injectable (Halpern, FHI 360) Microparticles, microspheres, crystal suspension To market Biodegradable implant (Nanda, FHI 360) MicroCHIP Remote-controlled implantable drug delivery microchip $4 million Gates Foundation grant Clinical trials > market 2018 Medicines360 LNG IUS (Levosert ) FDA NDA July 2014 Where are we going? Essure Transvaginal ultrasound study - recruiting Immediately effective device study Nonsurgical permanent (Jensen, OHSU) Primate trials of polidocanol (vein sclerosing agent) 11

12 Conclusions Emergency contraception options are safe and range from pills to the Cu IUD While the Cu IUD and UPA are most effective and least affected by weight, LNG is the most accessible option Increasing access to all forms of EC should be a priority Future contraceptive innovations will focus on improving continuation, safety, and access Fellowship in Family Planning Training in research, teaching, clinical practice in abortion and contraception 2yr Master degree International placement Public policy and advocacy 29 locations 12