Contraception: Common Problems Faced in Office Practice. Jane S. Sillman, MD Brigham and Women s Hospital

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1 Contraception: Common Problems Faced in Office Practice Jane S. Sillman, MD Brigham and Women s Hospital

2 Disclosures I have no conflicts of interest

3 Contraception: Common Problems How to discuss contraception What is the best method for your patient? How to start a contraceptive method Managing side effects Emergency contraception

4 Key questions When (if ever) do you want to have a child? 1-2 years: Short-acting contraceptive method is most costeffective 3 years or more Long-acting reversible contraception (LARC): IUD or progestin insert (Nexplanon) Depot medroxyprogesterone acetate (DMPA)

5 Key questions - continued What contraceptive were you thinking of using? Giving a patient what she asked for is associated with higher rates of continuation If she requests any method other than LARC, suggest that she consider LARC if appropriate Managing Contraception

6 Key questions - continued What would you do if you had an accidental pregnancy? If she would never consider abortion, stress using the most effective contraceptive method (LARC) What methods did you use in the past? What problems did you have with them?

7 Key questions - continued What are you doing to protect yourself from STIs/HIV? Counsel about adding condoms Do you know about emergency contraception (EC)? Give her a prescription for EC, encourage her to fill it, have it on hand Emphasize relative effectiveness of different methods Do you have any medical problems? Check if any medical contraindication to her method of choice

8 Your patient s medical eligibility Use the 2016 CDC Medical eligibility criteria MMWR Recomm Rep. 2016;65(4):1. Epub 2016 Jul 29

9 CDC: Medical contraindications to estrogen Breast cancer DVT DM with vasc. disease or >20 years Endometrial cancer Migraine with aura Uncontrolled HTN Ischemic heart disease Known thrombogenic mutation: Factor V Leiden Smoking in patient > age 35 SLE Complicated valvular heart disease MMWR Recomm Rep. 2016;65(4):1. Epub 2016 Jul 29

10 What methods are most effective?

11 Contraceptive Method Highly effective Sterilization 0.5 Implant 0.05 % Women with Unintended Pregnancy in 1 st Yr Typical use IUD Moderately effective DMPA 6.0 Pills: COCs, POPs 9.0 Ring 9.0 Patch 9.0 Managing Contraception

12 Contraceptive Method % Women with Unintended Pregnancy in 1 st Yr Less effective Diaphragm 12 Male condom 18 Withdrawal 22 Natural family planning: calendar, temp., mucus Typical use 24 Spermicides 28 No method 85 Managing Contraception

13 How to start contraception NEW: Use the Quick Start for all methods and everyone Start on the day the patient sees you Recommended for pills, patch, ring, injections, implants, IUDs Need to be reasonably certain that patient is not pregnant Managing Contraception

14 How to be reasonably certain that a woman is not pregnant 1. No intercourse since last menses 2. Using reliable method consistently 3. < 7 days after start of menses 4. Within 4 weeks postpartum 5. < 7 days post abortion or miscarriage 6. Breastfeeding, no menses and < 3 months postpartum 7. Negative urine pregnancy test

15 Recommended protocol 1. Do urine pregnancy test 2. Offer emergency contraception if unprotected intercourse in preceding 5 days 3. Start method of choice 4. Use back-up contraception (condom or abstinence) for 7 days 5. Repeat urine pregnancy test in 2 weeks Contraception 2017;95:364

16 LARC: New data on duration of action

17 Copper IUD (ParaGard): Duration of action Initially approved by FDA for 10 years Now: Women between 25-34: 12 years Women > 35 years old: leave IUD in place till menopause Contraception 2014;89:495

18 52 mg levonorgestrel IUD (Mirena): New data on duration FDA approval for 5 years Increasing evidence: effective for 7 yrs Concern: younger LNG-IUD users have higher risk of pregnancy Current recommendation Patient aged < 35: 6 years of use Patient aged > 35: 7 years of use Am J Obstet Gynecol June 2017; 216 (6): 586.e1

19 Etonogestrel implant (Nexplanon): New evidence on duration FDA approval for 3 years Evidence: WHO trial: 204 women with etonogestrel implant use for 5 years: 100% efficacy Effective for 5 years in women of any age Hum Reprod 2016;31(11):2491 Am J Obstet Gynecol 2017 June;216:586.e1

20 Managing common side effects

21 Irregular bleeding: Copper IUD Typically causes heavier periods Up to 50% increase in average monthly blood loss. May decrease over time 1 st year removal rate for pain, bleeding: 12% Spotting, frequent or heavy bleeding Rule out pregnancy, infection, cervical lesion, expulsion of IUD Management: NSAIDs for 5-7 days Obstet Gynecol Clin North Am 2015;42(4):593. Epub 2015 Sept 16

22 Irregular bleeding: levonorgestrel (LNG) IUDs Menstrual changes Menorrhagia improves! Number of spotting, bleeding days 1 st three months: higher than normal After 3-6 months: lower than normal Amenorrhea occurs in 20% of women after one year Removal for bleeding problems in first year: 7.6% Management NSAIDs x 5-7 days Obstet Gynecol Clin North Am 2015;42(4):593. Epub 2015 Sept 16

23 Irregular bleeding: etonogestrel implant Unpredictable/irregular bleeding frequent, may persist Usually light, well tolerated Management NSAIDs 5-7 days Several cycles of low-dose combined oral contraceptive (COC) if medically eligible MMWR Recomm Rep. 2016;65(4):1. Epub 2016 Jul 29

24 Irregular bleeding: Injectable (DMPA) users Menstrual Every woman s periods change on DMPA: less menstrual blood loss, 50% have amenorrhea after one year Abnormal bleeding Rule out pregnancy, infection, vaginal or cervical lesion Spotting or light bleeding: NSAIDS for 5-7 days Heavy or prolonged bleeding NSAIDs for 5-7 days Hormonal treatment (if medically eligible): estrogen 1-4 times a day for 5 days, COC pill x 1-2 cycles MMWR Recomm Rep. 2016;65(4):1. Epub 2016 Jul 29

25 Irregular bleeding: Combined hormonal contraceptive (CHC) Pill, patch, ring Breakthrough bleeding common in 1 st three months: reassure, check re using CHC consistently After three months Evaluate re pregnancy, infection, cervical lesion Cyclic use: 7 days of estrogen Continuous use: 3-4 day hormone-free interval Speroff L,, Darney PD. A Clinical Guide For Contraception, 54 th ed, 2011 MMWR Recomm Rep. 2016;65(4):1. Epub 2016 Jul 29

26 If irregular bleeding persists or patient finds it unacceptable Reassess re diagnosis Counsel on alternative methods Offer another method if desired

27 The problem of DVTs Risk is associated with the dose of estrogen: risk of DVT in 50 mcg pills is greater than in mcg pills The type of progestin may slightly influence DVT risk The progestins desogestrel (DG) and drospirenone appear to be associated with greater DVT risk than levonorgestrel (LNG)

28 No COC 10 COC pill w LNG 50 COC pill w DG or drospirenone Hormonal contraception: absolute risks of DVT Absolute risk of DVT/100,000 women per yr 100 Patch 97 Ring 78 Pregnancy 200 BMJ 2011;343:d6423. BMJ 2012;344:e2990

29 DVT minimizing risk Check that patient is medically eligible for combined hormonal contraception No h/o DVT/PE, no recent major surgery with prolonged immobilization No h/o thrombophilic disorder: Factor V Leiden Combined oral contraceptive pill Avoid pills with progestins desogestrel and drospirenone Start with a low-estrogen pill: 20 mcg

30 DVT- minimizing risk, continued The patch Delivers 60% more estrogen over a 21 day period than a 35 mcg pill and 3 x more than vaginal ring Would avoid Vaginal ring Lowest serum levels of estrogen and progestin compared to pills, patch OK to use

31 Hypertension

32 CDC Medical Eligibility Criteria (MEC) and hypertension Hypertension MEC Adequately controlled HTN 3 Systolic BP or diastolic BP 160/100 or higher 4 Evidence of vascular disease/other CV risk factors 4 3: Risks usually outweigh advantages 4: Unacceptable health risk MMWR Recomm Rep. 2016:65(4):1. Epub 2016 Jul 29

33 Hypertension and COCs OK to start COC in patient with controlled hypertension with careful monitoring of BP 1% of COC users will develop hypertension Standard evaluation: Check BP after 3 months on COC If BP > 130/80, d/c COC Increased BP due to the COC will return to normal within 1-3 months of discontinuing COCs

34 Headaches

35 New onset or worsening headaches in COC user: scenario #1 Focal neurologic symptoms with headache: suggestive of migraine with aura STOP COCs Offer progestin-only or non-hormonal contraception

36 New onset or worsening headache in COC user: scenario #2 Symptoms only with menses Due to decline in estrogen concentration at time of placebo pills Switch to continuous COC If headaches resolve, continue this treatment Headache 2008;48(8):1186

37 Headaches are associated with many hormonal contraceptive methods Levonorgestrel IUD: < 16% 1 Etonogestrel implant: 25% 1 DMPA: 9-17% 1,2 Severe headaches can occur Consider switch to another method Vaginal ring: 6% 3 1. Lexicomp Online 2. Headache 2006;46(3): Obs Gynecol 2002;100:585

38 Decreased libido

39 DMPA Hypoestrogenism can cause decreased libido, dyspareunia, hot flashes Management: consider switching to different method Obstet Gynecol 2016 Mar;127(3):563-72

40 Conflicting data Combined oral contraceptive pills and libido Decreased libido and anorgasmia can occur COCs are associated with decrease in free testosterone but no proof that this causes the decrease in libido Treatment with androgens does not help Management: consider switching to different method Obstet Gynecol 2016 Mar;127(3): Clin Endocrinol (Oxf). 1980;12(4):327

41 Weight gain

42 DMPA can be associated with significant weight gain Weight gain >5% at 6 months associated with increased risk of future weight gain Management Weigh patient at every visit Discuss if gain of 5% or more Eat less, exercise more Consider weight management program If ongoing weight gain, consider switch to another method Contraception 2013 May;87(5): Epub 2012 Nov 21

43 No evidence that COCs cause weight gain Average weight gain no different in COC users than in placebo users Gallo MF et al. Cochrane Database Syst Rev 2014

44 Depression

45 Levonorgestrel IUDs are associated with mood changes Progestin effect is primarily local but there is some systemic absorption Depression: 4-6% Anxiety: 8% Lexicomp Online

46 Depression and anxiety can occur with DMPA Depression: 1-<5% More likely in patients with history of premenstrual syndrome or mood disorder Anxiety: 1- <5% Management Ask about mood at follow-up If patient depressed, evaluate suicide potential D/C DMPA if concerned about ongoing use Lexicomp Online. Am J Obstet Gynecol 2000;183(6):1419

47 Conflicting data on impact of COCs on mood U.S. recent report: beneficial effect of COCs on mood Prospective study of over one million women in Denmark Small increase in antidepressant use in pill users versus nonusers Recommendation: Ask about changes in mood during follow-up visits Am J Epidemiol 2013 Nov;178(9): Epub 2013 Sept 15 JAMA Psychiatry 2016;73(11):1154

48 Problems with adherence

49 COCs: one missed pill Take the pill ASAP Take remaining pills at usual time, even if need to take 2 pills a day If pill was missed in last week of cycle (e.g. days in 28-day pack), finish active pills and start new pack next day No additional contraception is needed Emergency contraception usually not needed CDC MMWR July 29, 2016, Vol. 65:No. 4

50 COCs: two or more consecutive pills are missed Take most recent missed pill ASAP Take remaining pills at usual time, even if means taking 2 pills on same day Use back-up contraception (condoms) or avoid intercourse until pills have been taken for 7 consecutive days Consider emergency contraception if pills were missed in 1 st week and unprotected sexual intercourse occurred during that week CDC MMWR July 29, 2016, Vol. 65:No. 4

51 DMPA: returning late for repeat injection DMPA users should return every 13 weeks for repeat injections If woman more than 2 weeks late for injection (>15 weeks): Do pregnancy test Inject DMPA Use back-up contraception (or abstinence) for 7 days MMWR Recomm Rep. 2016;65(4):1. Epub 2016 Jul 29

52 Emergency Contraception

53 Ulipristal ( Ella ): Better than Plan B Progestin receptor modulator: suppresses or delays ovulation One 30 mg pill: take no later than 5 days after intercourse More effective than levonorgestrel (Plan B) Very safe Often needs to be ordered by pharmacist Ann Pharmacother 2011;45:780. Contraception 2014 May;89:431

54 Levonorgestrel: Plan B One-Step One pill: levonorgestrel 1.5 mg Mechanism: inhibits ovulation Take ASAP but can be used up to 5 days after intercourse Availability Brand name: OTC without age restrictions Generic: OTC to people > age 17 and to people of any age in 9 states including MA, VT, NH and 34 countries Cheng L et al. Cochrane Database Syst Rev. 2012

55 Meta-analysis: ulipristal better than levonorgestrel 3242 women: ulipristal or levonorgestrel within 72 hours of intercourse Pregnancies # % Ulipristal % Levonorgestrel % OR 0.58, CI , P=0.046 Lancet 2010;375:555

56 Advance provision Recommend that patients have home supply of emergency contraceptives in addition to regular contraceptive method Available when/if needed Give prescription at annual exam, encourage patient to fill it J Adolesc Health 2016:58(2):245

57 BMI affects efficacy of ulipristal (UPA) and levonorgestrel (LNG) BMI Pregnancy, % UPA LNG Normal Overweight Obese Overweight: ulipristal or IUD Obese: IUD best, then ulipristal Contraception 2011;84:363

58 Copper IUD Most effective EC method Insert up to 5 days after intercourse Mechanism: inflammation Toxic to sperm and egg Interferes with implantation

59 Emergency contraception: Efficacy If 1000 women have intercourse Method # pregnant % reduction No rx 80 - Levonorg Ulipristal 5 94 IUD 1 99

60 Your patient may ask about these new contraceptive options The one-year vaginal ring: Annovera New mobile app to detect fertile time: Natural Cycles

61 One-year vaginal ring: Annovera Approved by the FDA 8/10/2018 Combined hormonal contraceptive: segesterone acetate and ethinyl estradiol Post-marketing studies on risk for DVT pending Reusable ring Placed in vagina for 3 weeks followed by 1 week out Washed and stored in a compact case for the 7 days not in use Possible advantage: 1 prescription for whole year

62 New mobile app to detect fertile time: Natural Cycles Approved by FDA 8/10/2018 Algorithm calculates days of month when likely to be fertile Patient takes daily AM temperature with basal body thermometer, enters temperature and menstrual cycle information into app She needs to abstain or use protection when use protection appears on the app Clinical studies of effectiveness: typical use: 6.5% of women with unintended pregnancy in 1 year

63 Key Points LARC is best method if pregnancy not wanted in next 2 years Use Quick Start for all contraceptive methods LARC methods last LONGER than we used to think Irregular bleeding can often be treated with NSAIDs COCs and headaches New onset headache with focal neurologic symptoms during active COC pills: STOP COCs Headache during menses: due to estrogen decrease: give continuous COC Emergency contraception: discuss and give prescription

64 Next steps Ask patient when she wants to have a child. If in > 2 years, recommend LARC for contraception Use the Quick Start Remember current thinking about LARC durations of efficacy Copper IUD: woman > 35 years old at time of placement can leave IUD in place until menopause 52 mg LNG IUD (Mirena) Patient aged < 35: 6 years of use Patient aged > 35: 7 years of use Etonogestrel implant: 5 years

65 Next steps - continued Irregular bleeding IUD, implant, DMPA: treat with NSAIDS for 5-7 days Cyclic COC: give estrogen Continuous COC: d/c for 3-4 days Headaches on COCs Associated with focal neurologic symptoms: STOP COCs Occurring during time of low estrogen (during menses) Are DUE to drop in estrogen level Treat WITH continuous COC Emergency contraception: tell patient to fill prescription now

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