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Hormonal Contraceptives: Good, Bad and Controversial

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Presentation on theme: "Hormonal Contraceptives: Good, Bad and Controversial"— Presentation transcript:

1 Hormonal Contraceptives: Good, Bad and Controversial
Herbert L. Muncie, Jr., M.D.

2 Susie 15 year old female comes in to discuss contraception
She is healthy but wanted to talk about starting birth control pills What questions need to be asked? What issues need to be addressed before considering hormonal contraception

3 Oral contraceptives (OCPs)
Approximately 80% of women will use OCPs during their lifetime Success rate if instructions followed perfectly % first year of use Any missed pills - success rate 95% Adolescent’s success rate %

4 OCPs - Estrogens Two in U.S. - Ethinyl estradiol (EE)
Mestranol - 50 µg converted to 40 µg of EE

5 OCPs - Progesterones Progesterone Classification Family
Ethynodiol diacetate Norethindrone Norethindrone acetate 1st Generation Estrane (short ½ life) Levonorgestrel (LNg) Norgestrel 2nd Generation Gonane (longer ½ life) Desogestrel Norgestimate 3rd Generation Gonane

6 Progestins (family) & OCPs
Examples Demulen® 1/35 Ethynodiol diacetate Norinyl® 1/35, Ovcon®35, Ortho Novum 1/35® Norethindrone Loestrin® Norethindrone acetate Alesse®, Lybrel®, Seasonale®, Triphasil®, Tri-Levlen® Levonorgestrel Ovral®, Lo-Ovral® Norgestrel Desogen®, Mircette®, Ortho-Cept® Desogestrel Ortho-Cyclen®, Ortho Tri-Cyclen® Norgestimate

7 Mechanisms of action Estrogen component
Inhibits ovulation by suppressing FSH & LH Alters secretions & cellular structure of endometrial lining Prevents implantation

8 Mechanisms of action Progesterone component
Inhibits ovulation by suppressing LH Thickens cervical mucous & impairs sperm transport Alters endometrial lining Prevents implantation

9 Dosage and formulations
EE always ≤ 50 µg 20 μg pill in randomized trial had reduced breast tenderness and bloating 20 mcg pills have higher failure rate with missed pills (Medical Letter Treatment Guidelines 2007) 10 mcg pill approved (Lo-Lo-Estrin®) Progestin ≤ 1 mg Primarily responsible for contraceptive efficacy

10 OCP - Yasmin®, Yaz® First with progestin – drospirenone 3 mg
Analog spironolactone Avoid in renal insufficiency, hepatic dysfunction or adrenal insufficiency Manufacturer recommends measuring K+ during 1st cycle in women regularly taking drugs that may increase K+ (ACE, ARB or NSAID) Studies examining hyperkalemia & associated arrhythmias have not found higher rates including women taking K+ sparing drugs

11 OCP - Yasmin®, Yaz® Equivalent benefit with acne
Improves hirsutism & lowers BP Initial weight loss followed by gradual weight return Thromboembolism has been reported

12 33 250 Audience Question 18 year old female with mild acne wants to start OCP for contraception. Normal physical, no prior OCP use. Periods variable from 26 – 45 days. For this patient I would prescribe a: Monophasic pill Biphasic pill Triphasic pill Nonhormonal contraception method

13 Monophasic pills Estrogen Progesterone Day 1 Day 21

14 Biphasic pill (Necon®)
Estrogen Progesterone Day 11

15 Triphasic pills Estrogen Progesterone Day 8 Day15
Examples – Caziant®; Cylessa®; Necon 7/7/7®; Ortho-Novum 7/7/7 ®; Ortho Tri-Cyclen ®; Tri-Sprintec®; TriNessa®; Velivet®

16 Triphasic pills Estrogen Progesterone
Ex. Tri-Norinyl®; Aranell®; Leena® Ex. Estrostep Fe®; TriLegest Fe®; Tilia Fe® Day 8 Day 17 Day 6 Day 13 Ex. TriNessa®; TriVora®; Enpresse® Day 7 Day 12

17 Four-phase pill Estrogen Progesterone
(Natazia®) estradiol valerate/dienogest 3 mg/0 mg x2, then 2 mg/2 mg x5, then 2 mg/3 mg x17, then 1 mg/0 mg x2 Estrogen Progesterone Day 3 Day 8 Day 25 Day 27

18 Monophasic, Biphasic or Triphasic?
Biphasic & triphasic pills were developed to reduce side effects of monophasic pills Biphasic with norethindrone associated with inferior cycle control compared to triphasic with levonorgestrel [Cochrane Review 2005] Progestin may be more important than phasic type Monophasic pills give better cycle control Triphasic pills offer no physiologic advantage No data to support triphasic over monophasic pills

19 OCP general benefits Decreased dysmenorrhea Reduced menstrual flow
Reduced risk of anemia Improves acne Eliminate mittelschmerz Decreased risk of ectopic pregnancy Decreased risk of PID Decreased sxs of PMS Improvement in endometriosis Suppression of ovarian & breast cyst formation

20 OCP – Benefit Endometrial cancer reduced
50% reduction if used in prior 12 months Maximum protection if use continues for 3 years Protection lasts for 15 + years High or low dose pills provide protection

21 OCP – Benefit Ovarian cancer reduced
40% reduction in risk over nonusers High dose or low dose pills - same benefit Begins after 3-6 months of use 80% reduction after 10 years of use Reduced risk with family history ovarian CA & 4-8 yrs. use

22 OCP Cardiovascular Risks
Increased risk of CVD in smokers over age 35 Small increased risk MI with 2nd generation progesterones Only with current users – no lingering effect Slight increased risk of ischemic stroke 2-6 fold increase of ischemic stroke with history of classic migraine

23 OCP - Risks Headaches May increase or decrease
Headaches attributed to initiation of OCP tend to improve over time If HA persists with normal BP & no focal deficit Lower dosage of estrogen, progestin or both (no evidence effective) If HA persists with increased BP or focal deficit Discontinue OCP Answer to question # 2

24 OCP - Risks OCP use associated with increased risk of developing systemic lupus erythematosus (SLE) Especially if started recently [Bernier 2009] However, very low risk overall

25 VTE Risk VTE Risk 3-6 fold increased risk VTE, highest first 6-12 months of use (SOR B) Older women have greater risk > age /100,000 person-years Adolescents /100,000 person-years Obesity doubles the risk

26 VTE Risks VTE Risk Risk decreases with longer duration of use
For same estrogen dose - desogestrel & drospirenone have significantly higher risk [Lidegaard 2009] Grapefruit juice can augment bioavailability of EE [Grande LA 2009]

27 OCP Risks - EBM Risks (SOR B)
Increase in cervical cancer after 8 or more years of use after adjusting for HPV infection Risk of CIN with oncogenic HPV Decreased with depot-medroxyprogesterone (DMPA - Depo-Provera®) No association with combination OCPs [Harris 2009]

28 OCP Risks/Benefits - EBM
No increased risk of weight gain (SOR A) Weight gain does occur with DMPA – 5.1 kg No increased risk breast cancer (SOR B) No consistent change in breast milk production (SOR A) Or in infant growth or weight (SOR B) Women who use OCP are not at an increased risk of death later in life In fact a net benefit was found Berenson 2009 for randomized trial of DMPA and weight gain. Hannaford 2010 BMJ 340:c927. Royal College of General Practitioner’s OC Study. Women followed for up to 39 years.

29 OCPs can be used with these conditions
Diabetes mellitus < 35 years old Nonsmoker > age 35 Smokers < 35 years old Obese women Caution > age 39 Controlled hypertensive Ulcerative colitis Pituitary adenomas After gestational diabetes

30 OCPs and Stable SLE - EBM
OCPs are safe & do not increase the risk of flares in women with stable SLE InfoRetriever Randomized controlled trial (double-blinded) Level of Evidence (LOE) 1 b

31 OCP Contraindications
History of DVT, PE or arterial clotting Family history clotting or thrombotic events Family history (FH) if positive is risk factor VTE Ask if parent or sibling ever had VTE Positive FH if 1 relative was < 50 yo when VTE occurred Positive FH if 2 or more relatives at any age had VTE [Bezemer 2009] Answer to TQ#3

32 OCP Contraindications
Smoking and ≥ 35 years old Uncontrolled hypertension Migraine with aura Undiagnosed genital bleeding Answer to TQ#3

33 OCP Contraindications
Pregnancy – not harmful, just too late Sickle cell (SS) or sickle C (SC) disease not absolutely contraindicated DMPA may be preferable for SS disease

34 Duration of Use Non-smokers – OCPs can be used into menopause
To determine if menopausal d/c OCP & obtain FSH one month later If FSH > 40 ng/mL = menopausal Not proven reliable indicator, alternative just stop in early to mid 50s Smokers – stop at age 35 If treating vasomotor symptoms consider continuous active pills

35 Drug Interactions Vitamin C Antibiotics Increases estrogen level
Can induce nausea Discontinuation of vitamin C may precipitate bleeding Decreased estrogen level Antibiotics Unclear impact on efficacy

36 Drug Interactions Anticonvulsants
Advise patients to use a different form of contraception Because some anticonvulsants may reduce efficacy of OCPs If you & patient decide to use OCP, use pill with 50 µg EE If breakthrough bleeding occurs with that pill Patient should use alternative contraceptive method

37 Frequency of menstruation
Before initiating OCPs ask how often the patient wants to menstruate Monthly? (Every 4 weeks) Quarterly? (Every 91 days) Never?

38 Rarely Menstruate Seasonale® (2004)
84 days active pills with levonorgestrel (0.15 mg) & EE (30 mcg) 7 days placebo Increased risk unsuspected bleeding first months of use

39 Never Menstruate Lybrel® approved in 2007 for continuous use
365 days active pills EE 20 mcg & levonorgestrel 0.09 mg every day

40 Continuous OCPs Women who use a continuous combination OCP will have less bleeding without an increase in adverse effects Reduced frequency of hormone withdrawal side effects Reduced headache, pelvic pain, bloating, breast tenderness

41 Susie 15 year old female who came in to discuss contraception
Questions that were asked Family history negative for VTE or cancer Wants to menstruate monthly Given prescription for generic monophasic pill and she was told to start the pills today Had a negative pregnancy test in the office 41

42 OCP formulations OCP Active Placebo Low dose active Standard 21 7
Mircette® 2 5 Seasonique® 84 Loestrin® 24 Fe 24 4 Yaz® (20 mcg EE) Femcon® Fe (chewable pill) Natazia™ 26

43 35 250 Question You are starting for the first time OCPs with a 19 yo patient. No previous OCP use. Normal family history & physical exam. When will you advise her to take the first pill of the first pack? The Sunday after her next period starts The first Sunday after next period ends The first day of her next period The day I see her in the office

44 Starting OCPs – 3 Options
“Sunday start” – take the 1st pill of the 1st pack the 1st Sunday after onset of menses Reduces menses on weekend May not suppress ovulation with first cycle Advise additional contraception 1st month Answer to TQ#2

45 Starting OCPs – 3 Options
“First-day start” - take the 1st pill of the 1st pack the 1st day of next menses Easier to remember & explain Immediately protective as birth control Less breakthrough bleeding Answer to TQ#2

46 Starting OCPs – 3 Options
“Visit day start” - take the 1st pill of the 1st pack the day of the visit “Quick start” - watch patient take 1st pill Negative pregnancy test & no intercourse prior 2 weeks, no immediate follow-up If intercourse within prior 2 weeks, repeat pregnancy test in 2 weeks Additional contraception the first 7 days Answer to TQ#2

47 Quick-Start contraception
Main benefit is reduced time explaining how to start pills [Westhoff 2007] No evidence reduced risk of pregnancy or discontinuation rates for OCPs [Cochrane 2008] Fewer women on quick-start Depo-Provera became pregnant than women who started another method [Lopez 2008] Answer to TQ#2

48 The Prescription Dr. Understanding Sarasota, Fl Jane Smith
Sig: 3 OCP Packs Refill: x 3 Dr. Understanding Sarasota, Fl Jane Smith Sig: 1 OCP Packs Refill: x 12

49 Better Option? Dispensing 13 cycles at a single visit lead to better continuation rates & decreased cost [Foster 2006] Women who received 13 cycles were more likely to have PAP testing & chlamydia screening Dr. Understanding Sarasota, Fl Jane Smith Sig: 13 OCP Packs Refill: x 0

50 Audience Question How often are pills forgotten?
35 250 Audience Question How often are pills forgotten? During a three month period, how many pills does the average woman miss each cycle? 1.2 2.6 3.5 4.1 4.9 Using electronic information, it was found that an average of 2.6 pills were missed each cycle. However, in a trial of daily text-message reminders, the average number of missed pills was 4.9 per cycle. And no pregnancies occurred with this level of compliance. [Hou 2010, Ob Gyn 116:633] What seems to be the situation is that some women are excellent at remembering to take the pill and others are not. No demographic characteristic can identify the good versus poor takers. Compliance was not enhanced with group motivation, structured, peer or multicomponent counseling or intensive reminders.

51 Missing pill instructions
First ask which pill(s) were missed: If placebo pill just skip it If active pill and < 24 hrs late Take immediately If active pill and ≥ 24 but < 48 hrs late Take both pills at the same time Additional contraception not required

52 Missing pill instructions
If 2 active pills missed Double up for 2 days Use additional contraceptive method for 7 days Consider emergency contraception if unprotected intercourse If ≥ 3 active pills missed Stop pills and begin new pack Discuss alternative contraceptive options that do not require daily compliance Answer to TQ #1

53 Most Dangerous pill to Miss?
Most dangerous pill to miss is the 1st pill of the new pack Pill free > 7 days increases risk ovulation Use additional form of birth control until taken 7 consecutive active pills Stress compliance with starting each new pack AMS Note: not a © - picture taken by EK, brands hidden. 10/28/10

54 33 250 Audience Question 26 y.o. patient at her 6 weeks postpartum visit requests contraception. Exclusively breastfeeding. Used combination OCP is the past. Which contraceptive option would you recommend? Progesterone IUD Low-dose combination OCP Progesterone only OCP Continue exclusively breastfeeding and return for contraception at 6 months or when supplementing with formula 54

55 Progestin only pills Thicken cervical mucous & prevent sperm ascending through os Erratic suppression ovulation Irregular bleeding more common Daily compliance crucial Same time every day (2-3 hr difference can cause bleeding, allow ovulation) Are not contraindicated in smokers over age 35 55

56 OCP - Postpartum Can begin combination OCP ≥ 3 weeks postpartum after delivery ≥ 20 weeks gestation Starting < 3 weeks postpartum associated with increased risk of VTE Balance this against risk of unwanted pregnancy which has greater risk of VTE For delivery of < 20 weeks gestation - can begin combination OCP immediately 56

57 OCP – Breast feeding Can start combination OCP at 6 weeks post-partum if lactation is well established and other forms of contraception are not acceptable [ACOG Position Statement 2004] 57

58 33 250 Audience Question 26 y.o. patient at her 6 weeks postpartum visit requests contraception. Exclusively breastfeeding. Used combination OCP is the past. Which contraceptive option would you recommend? Progesterone IUD Low-dose combination OCP Progesterone only OCP Continue exclusively breastfeeding and return for contraception at 6 months or when supplementing with formula 58

59 Progestin only pills Thicken cervical mucous & prevent sperm ascending through os Erratic suppression ovulation Irregular bleeding more common Daily compliance crucial Same time every day (2-3 hr difference can cause bleeding, allow ovulation) Are not contraindicated in smokers over age 35 59

60 OCP - Postpartum Can begin combination OCP ≥ 3 weeks postpartum after delivery ≥ 20 weeks gestation Starting < 3 weeks postpartum associated with increased risk of VTE Balance this against risk of unwanted pregnancy which has greater risk of VTE For delivery of < 20 weeks gestation - can begin combination OCP immediately 60

61 OCP – Breast feeding Can start combination OCP at 6 weeks post-partum if lactation is well established and other forms of contraception are not acceptable [ACOG Position Statement 2004] 61

62 Hormonal Contraception - Other than Oral

63 Contraceptive Patch Ortho Evra® (EE 20 mcg; norelgestromin 150 mcg/day) Apply abdomen, buttocks upper torso (exclude breast) or upper outer arm One patch a week for 3 weeks, 4th week patch free

64 Contraceptive Patch Equally efficacious to OCP Side effects
Breast discomfort, headache, nausea & cramps – perhaps more than with OCP Less effective - women > 90 kg FDA warning of higher hormone levels than previously reported – may increase risk of VTE

65 Hormonal vaginal ring NuvaRing® - EE15 mcg & etonogestrel 12 mcg/day
One ring for three weeks No ring for one week If ring is out > 3 hours use additional contraception until ring in place for 7 days Does not have to be in specific position Hormones absorbed anywhere in vagina

66 Hormonal vaginal ring NuvaRing®
Contraceptive hormone levels for 35 days Alternative regimen One ring a month Same day of the month (e.g. 12th of every month) Reduces number of menses & hormonal withdrawal side effects [Sulak 2008]

67 Patch & Ring – EBM Cochrane review found:
Patch caused more side effects than OCP Ring caused fewer side effects than OCP Except vaginal discharge & vaginitis

68 Obese women - EBM What hormonal contraception is most effective?
Depo-Provera & NuvaRing® are not affected by body weight (SOR B) Obese women using oral contraceptives have increased risk of pregnancy (SOR B) [Clinical Inquiries 2007] However, new evidence found ovarian suppression was the same for obese women who were consistent users of OCP A randomized trial of normal weight and obese women regarding ovarian suppression found no difference with two pill formulations. However, the obese women were less compliant and that could explain the reason for some data to suggest reduced ability to prevent pregnancy in obese women. [Westhoff 2010 Ob Gyn 116:275]

69 Contraceptive Failure Rate
Method Typical Use Perfect Use No method 85% Diaphragm with spermicide 16% 6% Condom – male 15% 2% OCPs 8% 0.3% Transdermal Transvaginal Injectable 3% IUD – copper 0.8% 0.6% IUD – progesterone 0.2% Implant 0.05%

70 Emergency Contraception (EC)
Woman at risk for unwanted pregnancy Condom broke or slipped Forced intercourse Intercourse and no method of BC Diaphragm or cervical cap dislodged Two or more OCPs missed or forgotten > 12 weeks from last depo progesterone injection Missed first pill of OCP

71 Emergency Contraception
Woman at risk for unwanted pregnancy Contraceptive patch (Ortho Evra®) Off > 24 hours during active week Left on > 9 days > 2 days late putting on active week patch NuvaRing® Taken out > 3 hours during active weeks Left in > 5 weeks in a row > 2 days late inserting new ring

72 Emergency Contraception
Mechanism of action - Inhibits or delays ovulation if prior to ovulation Interferes with egg/sperm transport Alters endometrium and prevents implantation Does not terminate established pregnancy ACOG - only contraindication is pregnancy Because it doesn’t work History of ectopic pregnancy not contraindication Careful follow-up since higher risk of repeat ectopic Smoking & over age 35 not contraindication

73 Emergency Contraception
Progestin only (Plan B®) 0.75 mg levonorgestrel – two doses 12 hours apart Single 1.5 mg pill available (Plan B - One Step®)

74 Emergency Contraception
Fewer side effects & better efficacy 95% within 24 hrs, 85% within hr Can be used up to 5 days after intercourse No clinical exam or pregnancy test is necessary before EC EC may be used again even if used before within the same menstrual cycle Available OTC for women ≥ 17 yo

75 Emergency Contraception
Ulipristal (Ella®) approved for EC Selective progesterone receptor modulator (SPRM) – 30 mg single dose Remains equally effective up to five day after unprotected intercourse Possibility it is less effective in women with BMI > 30 Requires a prescription No significant side effects but long-term data is not yet available

76 Emergency Contraception
Follow-up care Document patient has normal menses within 21 days Obtain B-hCG level if no menses in 21 days Discuss starting ongoing contraception at the start of induced menses

77 Key Points - Hormonal Contraception
No one OCP has any unique advantage Become comfortable with 4 formulations that allow adjustment in estrogen & progesterone dosage Weigh risks vs. benefits before initiating hormonal contraception Compliance may be enhanced with alternative delivery system (patch, ring) Discuss availability of emergency contraception

78 What Questions do you have?

79 References Berenson A et al. Changes in weight, total fat, percent body fat, and central-to-peripheral fat ratio associated with injectable and oral contraceptive use. Am J Obstet Gynecol 2009;200:329.e1-329.e8 Bernier M-O et al. Combined oral contraceptive use and the risk of systemic lupus erythematosus. Arthritis & Rheumatism 2009;61: Bezemer ID et al. The value of family history as a risk indicator for venous thrombosis. Arch Int Med 2009;169: Foster DG et al. Number of oral contraceptive pill packages dispensed, method continuation and costs. Obstet Gynecol 2006;108: Grande LA et al. Attention – grapefruit! Lancet 2009;373:1222. Hannaford PC et al. Cancer risk among users of oral contraceptives: cohort data from the Royal College of General Practitioner’s oral contraception study. BMJ 2007;335:651.

80 References Harris TG et al. Depot-medroxyprogesterone acetate and combined oral contraceptive use and cervical neoplasia among women with oncogenic human papillomavirus infection. Am J Obstet Gynecol 2009;200:489.e1-489.e8. Lidegaard O et al. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009;339:b2890 Lopez LM et al. Immediate start of hormonal contraceptive for contraception. Cochrane Database of Systematic Reviews 2008, Issue 2 Art. No.:CD006260 Sulak PJ et al. Frequency and management of breakthrough bleeding with continuous use of the transvaginal contraceptive ring: a randomized controlled trial. Obstet Gynecol 2008;112: Westhoff C et al. Initiation of oral contraceptives using a quick start compared with a conventional start: A randomized controlled trial. Obstet Gynecol 2007;109:


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