Hormonal Contraception Katherine Pereira, DNP, FNP-BC, FAAN, FAANP Disclosures None Objectives Choose appropriate contraception methods based on patient characteristics Discuss pharmacologic properties of various contraceptive methods Review CDC and WHO recommendations regarding contraception options and indications 1
Unintended Pregnancy Nearly half (49%) of pregnancies in the United States are not intended. 53% of these unintended pregnancies due to imperfect adherence Annual costs: $4.6 billion 10% of women 20-29 would switch to Long Acting Reversible Contraception: savings of $288 million annually Trussell J. et.al. Contraception 87.2 (2013): 154-161. State Trends for Unintended Pregnancies North Carolina 2010 95,000 unintended pregnancies 54% of all pregnancies -0.4% decrease since 2002 Of the 95,000 unintended pregnancies 69% Mistimed, 31% Unwanted 58% ended in birth, 27% Abortion, 14% Fetal Loss Kost, K. "Unintended Pregnancy Rates at the State Level: Estimates for 2010 and Trends Since 2002." (2015). Correct and consistent use Methods that require more effort by the user have higher typical failure rates Correct and consistent use of pills and condoms may be difficult for all ages Women ages 18-24, in last 3 months 45% missed > 1 pill 62% did not use condoms every time Frost, J. Darroch, J et.al. Perspectives on Sexual and Reproductive Health 40.2 (2008): 94-104. 2
Effectiveness Method Failure rate Cervical cap 9-32% Combination OCP s 0.3-8% Condom/spermicide 2-21% Depo-provera 0.3%-3% Diaphragm/spermicides 6-28% IUD (LNG/Copper) 0.2-8% Mirena 0.5-3% Abstinence 1-25% Progesterone only pills 0.5-3% sterilization 0.15%-0.5% Implanon 0.38% Ortho Evra Patch 0.3-10%) Nuvaring 0.3-9%) *Lower number denotes perfect use Resources World Health Organization: http://whqlibdoc.who.int/publications/2010/9789241563888 _eng.pdf U.S. Selected Practice Recommendations for Contraceptive Use, 2013: http://www.cdc.gov/mmwr/pdf/rr/rr6205.pdf Hormonal influences on the menstrual cycle GnRH released by hypothalamus LH and FSH 3
Effectiveness of family planning methods Tier 1 Tier 2 Tier 3 http://www.cdc.gov/reproductivehealth/unintendedpregnancy/contraception.htm US Medical Eligibility Criteria 1 =A condition for which there is no restriction for the use of the contraceptive method. 2 = A condition for which the advantages of using the method generally outweigh the theoretical or proven risks. 3 = A condition for which the theoretical or proven risks usually outweigh the advantages of using the method. 4 = A condition that represents an unacceptable health risk if the contraceptive method is used. 4
Reduction in Estrogen Dose 160 140 120 100 80 60 40 20 0 1960 1966 1975 1996 Estrogen Dose American Journal of Obstetrics and Gynecology, Volume 180, Issue 6, Supplement, 1999, S343 S348 http://dx.doi.org/10.1016/s0002-9378(99)70694-0 Oral contraceptives: Mechanism of Action Estrogen suppresses FSH preventing development of a dominant follicle Estrogen also promotes action of progestin, suppressing LH surge Estrogen also stabilizes endometrial lining Progestin effects Thickens cervical mucous Induces endometrial atrophy Impaired tubal motility 5
Associations with COC Cochrane Review 1400 patients and 4 trials Higher doses of estrogen than seen in current COC No association between weight gain and COC Gallo MF et.al. Cochrane Database of Systematic Rev 2011; (9). Assessing Risks Associated with COC < 21 Days Postpartum: Contraindicated (4) >42 Days Postpartum: No restrictions (1) Smoking Age <35 years Smoking Age > 35 years <15 cigarettes a day (3) >15 cigarettes a day (4) Assessing Risks Associated with COC CAD (4) Diabetes Without microvascular complications (2) With (neuropathy, retinopathy, nephropathy (3/4) Greater than 20 years duration (3/4) Systemic lupus erythematosus Positive (or unknown) antiphospholipid antibodies (4) Severe thrombocytopenia (2) Uncomplicated Valvular Heart Disease (2) 6
Assessing Risks Associated with COC Inflammatory Bowel Disease UC/Crohn s (2/3) Gall Bladder Disease: Medically Treated (3) Current (3) Treated with surgery (2) Liver Disease Hepatocellular Adenoma (4) Focal nodular hyperplasia (2) Hepatic Cancer (4) Assessing Risks Associated with COC Major Surgery Prolonged immobility (4) No prolonged immobility (2) Post Weight loss surgery Lap-band, Gastric Sleeve (1) Roux-en-y, biliopancreatic diversion (3) COC, (1) Ring and Patch Obesity BMI >30 (2) COC and Cancer Risk Reduced risk of endometrial cancer and ovarian cancer Cohort study of >50,000 women in UK Royal College of General Practitioner (RCGP) Study followed for 24 years Looked at ever users of the pill and cancer risks Those who ever used the pill had lower risk for GI and endometrial, ovarian cancers, and no increased cancer risk seen Nurses Health Study: ever users inverse association with colorectal cancer risk Hannaford P. et al. BMJ 335.7621 (2007): 651. Charlton B.et al. Cancer Epidemiology Biomarkers & Prevention 24.8 (2015): 1214-1221. 7
Weight Gain and Levonorgestrel-Releasing IUS (LNG-IUS) Trials note 5% of women gained weight Comparison of Copper IUD Vs. LNG-IUS in cohort of 79 new users: Weight of 1.7 vs. 2.9kg Comparison of weight gain in 427 women over 12 months etonogestrel (ENG) implant levonorgestrel intrauterine system (LNG-IUS) depot medroxyprogesterone acetate (DMPA) Black women had more weight gain than other groups after adjustment for variables Vickery Z. et al. Contraception 88.4 (2013): 503-508. Dal'Ava N. et al. Contraception 86.4 (2012): 350-353. Weight Gain and progestin only contraception (POC) Cochrane Review 2013 Moderate to low quality studies 10 studies depot medroxyprogesterone acetate (DMPA) 4 studies implants 1 study progestin only pills 1 study LUR-IUS Average of 2.1kg weight gain with DMPA compared to non-users of hormonal contraception with increase in body fat composition and decrease in lean body mass. Lopez LM et.al. Cochrane Database of Systematic Reviews 2013, Issue 7. Weight Gain and Medroxyprogesterone 8
Bone Mass and DMPA Decrease in bone mass thought to be r/t suppression of estradiol production (secondary to low gonadotrophins) Greatest loss seen in first 2 years of therapy Appears to return to baseline after discontinuation when studying post-menopausal women No increased risk in women with average risk Lanza L. et al. Obstetrics & Gynecology 121.3 (2013): 593-600. CDC/WHO: You can start COC Without a pelvic examination Without any routine blood work Without cervical cancer screening Without a breast examination Reasonably sure woman is not pregnant COC and Blood Pressure COC will raise BP in dose dependent fashion Normalization of BP will occur in 2-10 months after cessation of therapy Adequately controlled HTN: (3) Blood Pressure 140-159/90-99 (3) History of pregnancy associated high BP (2) Blood Pressure >160/>100 (4) 9
Type of Progestin and Risk Type of Progestin Odds Ratio of VTE compared to non-coc user Levonorgestrol 2.3 Norgestimate 2.53 Norethindrone 2.56 Gestodene 3.64 Drospirenone 4.12 Cypoterone 4.27 Desogestrel 4.28 VinogradovaY, et.al. BMJ 350 (2015): 2135 Headaches and COC Headaches non migraine (1) Migraine without aura <35 years (2) >35 years (3) Migraine with aura at any age (4) COC: Clinical Implications for Androgen Production and Acne LH decreased androgen synthesis by ovarian theca cells, net ovarian androgen production Sex Hormone Binding globulin increased binding of testosterone, bioavailability of circulating androgens conversion of testosterone to dihydrotestosterne (active androgen in hair follicles and skin) 10
Androgenic Activity of Progestins Level of Activity High Middle Low Progestin Norgestrel Levonorgestrel Northindrone Northindrone Acetate Ethynodiol Norgestimate Desogestrel Drospirenone Dienogest Extended Cycling with COC Provides more effective ovulatory suppression at lower doses of estrogen and progestin Withdrawal bleeding lighter Biggest SE is Breakthrough Bleeding (BTB) Good choice for women Acne breakouts Menstrual Migraines Iron Deficiency Anemia r/t menorrhagia Coagulation disorders (Von-Willibrand) Women in Military Breakthrough bleeding with Lybrel 11
Quartette : total 91 tablets 42 tablets containing levonorgestrel 150mcg + ethinyl estradiol 20mcg followed by 21 tablets containing levonorgestrel 150mcg + ethinyl estradiol 25mcg followed by 21 tablets containing levonorgestrel 150mcg + ethinyl estradiol 30mcg followed by 7 tablets containing ethinyl estradiol 10mcg 4 short and light menses a year The Post-Partum Woman Return to ovulation on average 25 to 45 days (nonbreastfeeding) Full Time breastfeeding 98% reliable contraception first 6 months post-partum 25 to 60% of women return to sexual activity at < 6 weeks post-partum Campbell et al. Obstet. Gynecol. Mar 2011;117(3):657-662 Long Acting Reversible Contraception IUD: Copper Etonogestrel (ENG) implant Levonorgestrel intrauterine system (LNG-IUS) Depot medroxyprogesterone acetate (DMPA) Unexplained Vaginal Bleeding (4) Cervical Cancer awaiting tx (4) Current breast cancer (4) PID/Uterine abnormalities (4) 12
Inserting LARC between cycles Recommendation is to improve access to LARC SAB or TAB within last 12 days (for copper IUD) or 7 days (for Mirena) Delivery within last 4 weeks. fully breastfeeding a baby < 6 months old and amenorrheic Otherwise wait till next cycle or Negative pregnancy test IUD in Nulliparous Women Retrospective cohort study: no difference in assessment of easy insertion in nulliparous vs. parous women (~80% ) Dilators required more in nulliparous women (7.7% vs. 3.1%) Difficult insertion more common in women with h/o C-Section Hall, A. Kutler B. Journal of Family Planning and Reproductive Health Care (2015). Misoprostol Vs. Placebo RCT comparing insertion with placebo vs. misoprostol 400mcg vaginally 4 hours prior to insertion (n=179) Compared to placebo: Less difficulty with insertion (p=0.0005) Less pain (p=0.0001) Lower risk for dilation <4mm (p=0.0008) Side effects of cramping (40% incidence) prior and after in misoprostol group Scavuzzi, Adriana, et al. Human Reproduction (2013) 1-8. 13
Difficult Insertions What patients have difficult/complicated insertions? (n=545): Nulliparous, especially older Provider experience Nulliparous also more likely to have vasovagal reactions Farmer M & Webb A. Journal of Family Planning and Reproductive Health Care 29.4 (2003): 227-231. Marion 26 year old woman with long history of irregular infrequent menses and BMI of 33 presents for annual exam and to discuss birth control for the first time. 6 month monogamous relationship with her boyfriend currently using condoms. No interest in pregnancy for a few years. ROS + for occasional HA prior to menses: + photophobia usually has to lay down in dark room and take Excedrin Migraine. No other neurological symptoms BP 133/80 Marion Physical exam: Moderate hirsutism on the chin, upper lip, breasts and lower abdomen. Pustular acne on upper back. Options and pros and cons 14
Tina 33 years old G5, P4, A1 Children ages 6, 4, 18 months, 3 days old This pregnancy unintended, occurred while nursing 3 days post partum, plans to nurse for 6 months C-Section for breach presentation, no other GYN history 15