LARC: What Is It and Why Is It Important for Teens? Jan Shepherd, MD, FACOG

Learning Objectives Define LARC and discuss why it can be important in preventing unintended pregnancy Discuss the increasing role of intrauterine contraception in family planning for all age groups Describe the contraceptive implant and discuss potential benefits and side effects of the method Describe the concept of a Reproductive Life Plan and how it can be used in counseling teens

Disclosure I am on the Speakers Bureau for Bayer (IUCs) Merck (Implant) Teva (IUD)

U.S. Pregnancies: Unintended vs. Intended 51% Unintended 49% Unintended births 29% Elective abortions 20% Guttmacher Institute; January 2012.

Teenage pregnancy is more common in the USA than in most other industrialized countries Source Presentation: Fulfilling the Promise: Public Policy and U.S. Family Planning Clinics

Our Teen Birth Rate is Declining Colorado United States Change from 1991-2011 -50% -49% Change from 2010-2011 -13% -8% And Colorado went from #23 to #29 in latest statistics CDC

But We Still Have Work To Do Total Teen Births 2011 Total Colorado United States Under 15 67 3,974 15-17 1,383 95,538 18-19 3,351 234,234 Race/Ethnicity Colorado United States Non-Hispanic White 37% 39% Non-Hispanic Black 7% 24% Native American 2% Asian or Pacific Islander 1% Hispanic 53% 33%

Colorado Statistics 41% of high school students (36% of females) have had sexual intercourse 4% (2% of females) had first intercourse before age 13 13% (11% of females) have had intercourse with 4 or more partners 7% (8% of females) did not use any contraception with last intercourse CDC

Contraceptive Use and Unintended Pregnancy 52% of unintended pregnancies attributable to sexually active women using no method 48% of unintended pregnancies — women using some form of birth control Mosher WD, Jones J. Vital and Health Statistics 2010.

First Year Contraceptive Failure: Perfect Use vs Typical Use 30 25 20 15 10 5 OCs DMPA Implants Condom Vasectomy Copper IUD Diaphragm Withdrawal Spermicides Progestin IUD Tubal Ligation Hatcher RA. Contraceptive Technology.

Typical Use * All especially common in teens Women forget to take pills Injectable users miss a shot Couples don’t use a condom every time they have sex Methods are used incorrectly Women do not expect to have sex Users’ supplies run out * All especially common in teens

Current Trends in Contraception Emphasizing greater success  Duration of action   Ease of adherence   Efficacy in typical use LARC: Long Acting Reversible Contraception Intrauterine contraception Subcutaneous implant Improved Counseling Reproductive Life Plan

Long- Acting Reversible Contraception = “Forgettable Contraception”

WHO Method Comparison

Intrauterine Contraception (IUC) Levonorgestrel Intrauterine Systems Copper T 380A

Debunking Myths About Intrauterine Contraception IUCs are abortifacients IUCs cause pelvic inflammatory disease (PID) IUCs cause infertility IUCs cannot be used in nulliparous women

IUC: Mechanism of Action Mechanism of Action - Spermicidal Foreign body reaction Copper T 380A Heavy metal toxic to sperm Levonorgestrel IUC Progestin thickens cervical mucous Prevents egg & sperm getting together Not an abortifacient

History of IUC Dalkon Shield Contraceptive Use in the US History of IUC Dalkon Shield Dalkon Shield Increased rate of PID, septic abortion, infertility Infections related to woven thread Off the market for over 30 years Modern IUCs are not your grandmother’s IUD .

IUCs Do Not Cause PID 5-Year Cumulative Rates of Discontinuation for PID A. Randomized trial comparing Mirena to CuT 380A B. Randomized trial comparing Mirena to Nova T P < .05 *Nova T is not available in the US. Sivin I et al. Contraception 1990;42:361-378. Andersson K et al. Contraception 1994;49:56-72.

IUCs Do Not Cause PID Therefore do not cause infertility Tubal infertility not linked to IUC use1 PID risk with cervicitis same with & without IUC2 Therefore can be used by women who have not had children, including adolescents 1. Hubacher D. NEJM 2001;345:561-7. 2. Grimes D. Lancet 2000;356:1013-9.

Fertility After Discontinuation of Contraceptive PID/Ectopic Pregnancy/Future Fertility Fertility After Discontinuation of Contraceptive 100 80 IUD OC Diaphragm Other methods 60 Pregnancies (%) 40 20 12 18 24 30 36 42 Months After Discontinuation Vessey MP, et al. Br Med J. 1983;286:106.

Copper T 380A (Paragard®) On US market since 1988 High efficacy (failure rate .5-.8% per year) Approved for 10 years use Changes in menstrual bleeding Can increase flow and cramping Controlled by NSAIDS

Cu T 380A September 2005 Labeling Changes Contraindications Removed “depressed immune conditions, including HIV” Recommended patient profile Removed multiparity Removed mutual monogamy

CuT380A and Menstrual Problems Counsel that first few periods likely to be heavier and may have increased cramping NSAIDS (e.g. ibuprofen) around the clock on the first day and continued for 3-5 days Decreases bleeding by up to 50%1 Symptoms usually improve after first few cycles2 1. Contraception 2013;87:549-66. 2. Contraception 2009;79:356-62.

Levonorgestrel IUS (Mirena®) 32 mm High efficacy (failure rate .2% per year) Approved for 5 years use Low systemic levels of hormone Changes in menstrual bleeding Irregular bleeding at first, then decreased flow or no periods (20%) Steroid reservoir 32 mm levonorgestrel 20-10 g/day

LNG IUS - Noncontraceptive Benefits FDA-approved for treatment of heavy menstrual bleeding Better than medical therapy* Decreases menstrual cramps (off-label) Even in medical conditions * N Engl J Med 2013;368:128-37.

New Levonorgestrel IUS (Skyla®) High efficacy (failure rate .4%/year) Effective for 3 years Smaller, thin inserter, lower hormone dose Approved for nullips Changes in menstrual bleeding Irregular bleeding at first, then short, light periods Levonorgestrel 14-5 μg/day

Risks of Intrauterine Contraception Expulsion - 3.2-5% Perforation - 1,000-2,000 Infection/PID - related to insertion If pregnancy occurs, ectopic possible 1 of 2 with Mirena and Skyla 1 of 16 with Paragard Discussion for patients http://bedsider.org/features/287

*Committee Opinion #539 October 2012. ACOG Statements On IUDs: “IUDs offer safe, effective, long-term contraception and should be considered for all women…” On Adolescents: “Providers should strongly encourage young women who are appropriate candidates to use this method.” “IUDs are safe to use among adolescents.” “IUDs do not increase an adolescent’s risk of infertility.” * *Committee Opinion #539 October 2012.

Which IUC? LNG IUS Cu T 380A Low-dose LNG IUS Woman with heavy flow or cramps Anyone who desires  bleeding/amenorrhea Cu T 380A Woman who prefers regular predictable cycles Wants/Needs to avoid hormones Prefers longer duration (10 years) Low-dose LNG IUS Lighter, less painful periods Lower systemic hormone exposure

The Subdermal Implant (Implanon®  Nexplanon®)

Norplant® Implanon®

Single-Rod Implant 2 mm 40 mm Rate-controlling membrane (0.06 mm) Core Core: 40% Ethylene vinyl acetate (EVA) 60% Etonogestrel (68 mg) Membrane: 100% EVA Core 6

Nexplanon®

Advantages 3 years of most effective contraception Pelvic exam not required Progestin-only method, can use When estrogen contraindicated If estrogenic side effects with another method Improves acne and menstrual cramps Insertion and removal easier than previous implants

Estradiol Levels During Treatment 1500 Implant n = 44 1250 Copper IUD n = 29 1000 Mean estradiol (pmol/L) 750 500 250 Baseline Month 12 Month 24 Last measurement  Does not affect bone density like Depo Provera does Beerthuizen R, et al. Hum Reprod. 2000;15:118-122

Discontinuation Rates due to Adverse Events Bleeding irregularities 11.0% (104/942) Weight gain 2.3% (22/942) Emotional lability 2.3% (22/942) Headache 1.6% (15/942) Acne 1.3% (12/942) Depression 1.0% (9/942) 1.7% of Women Experienced Problems at Removal IMPLANON™ [package insert]. Roseland, NJ: Organon USA Inc; 2006.

Bleeding Patterns Bleeding is usually irregular Can be light or heavy, short or prolonged Skipped periods most common Pattern can vary throughout the duration of use Total amount of bleeding/spotting days usually similar to or slightly less than a normal menstruating woman Key difference is the irregularity and unpredictability of the bleeding

Managing BTB with Nexplanon COUNSELING *Oral contraceptives, if not contraindicated Provera or Aygestin for 21 days x 3 mos Progestin-only pills x 3 months Estrogen x 10 days NSAIDs (e.g. ibuprofen) x 5-10 days Contraception 2008;78:106-112. Contraception 2011;83:203-2010.

Managing Hormonal Side Effects with Implant (or LNG- IUS) Acknowledge client’s concerns Agree to remove it if she desires Point out very low incidence of these side effects, then: “Is there anything else in your life that could be causing this headache, moodiness, etc.” Remind client that if related to the method, side effects usually decrease over time

Role of LARC: CHOICE Project Method Chosen LNG IUS – 45% Copper IUD - 10% Implant – 13% Depo Provera – 8% OCPs – 23% Obstet Gynecol 2011;117:1105-13.

Continuation: CHOICE Project 1 year1 2 year2 LNG IUS – 88% Copper IUD – 85% Implant - 83% Depo Provera – 57% OCPs – 55% LARC – 87% Non-LARC – 57% LNG IUS – 79% Copper IUD – 77% Implant - 68% Depo Provera – 38% OCPs – 43% LARC – 77% Non-LARC – 41% 1. Obstet Gynecol 2011;117:1105-13. 2. Obstet Gynecol 2013;122:1083-91.

Efficacy of LARC: CHOICE Project 22X more effective than pill, patch or ring (0.27 vs. 4.27 pregnancies per 100 women) Double this effect in teens Rate of teenage birth in the CHOICE cohort 6.3/1000 vs. 34.3/1000 nationally Rate of abortion less than half the regional and national average 1. N Engl J Med 2012;366;1998-2007. 2. Obstet Gynecol 2012;120:11291-7.

Depo Provera The almost-LARC

Depo Provera (DMPA) Amenorrhea Highly Effective (.22 pregnancy rate) Positives Negatives Highly Effective (.22 pregnancy rate) Easy to use Anonymous Can use when estrogen contraindicated No drug interactions Amenorrhea Prolonged pituitary suppression Median time to pregnancy is 9–10 months Up to 18 months is WNL Weight gain Vaginal dryness Adverse effect on lipids ↓ Bone density

Recovery of Bone Density in Adolescents J Adolesc Health 2006;39:296-301.

Committee Opinion #415 September 2008. ACOG Statement “Concerns regarding the effect of DMPA on bone mineral density should neither prevent practitioners from prescribing DMPA nor limit its use to 2 consecutive years.” Committee Opinion #415 September 2008.

Improved Contraceptive Counseling  Reproductive Life Plan Being intentional about preparing for and starting pregnancies Making conscious decisions about When to have children How many to have Ensuring the healthiest pregnancies and families CDC

Reproductive Life Plan = True “Family Planning” Encouraging clients to think about contraception In terms of Planning for when they do want children Protecting themselves until that time Not just for this year or this relationship

Reproductive Life Plan Clinicians help clients make a Reproductive Life Plan by asking: Do you hope to have children? More children? How many? When? Every woman, every year

Reproductive Life Plan Avoiding unintended pregnancy More effective use of contraception First-line option for many LARC: Long Acting Reversible Contraception Fertility-preserving behavior Planning for desired pregnancies Preconception care

Case A 16-year-old, newly sexually active, presents to the clinic for her first appointment, requesting contraception. Do you plan to have children? Yes How many? Two or three When? Not until I finish high school and college

Reproductive Life Plan Avoiding unintended pregnancy Effective use of contraception First-line option LARC: Long Acting Reversible Contraception Intrauterine contraception Subcutaneous implant Protection against STIs!

More Ways to Encourage Use of LARC You are >22 times more likely to become pregnant with OCPs, patch, or ring than with a LARC method! Ask about feasibility of daily pill taking  “How often do you want to have to think about your birth control?” Get It and Forget it Anticipate and dispel misconceptions

Counseling About Safety LARC methods are very safe All avoid the blood clot risks of estrogen-containing methods All reduce the risk of ectopic pregnancy and certain cancers IUC is the #1 method of birth control in the world and its use is on the rise in the US

LARC *Always need condoms to prevent STIs Methods requiring attention > q 3 years Independent from Intercourse User motivation and adherence Do not require frequent visits for resupply Highest effectiveness, continuation rates, and user satisfaction proven in teens Excellent safety record *Always need condoms to prevent STIs