Contraception

This presentation contains materials obtained from Linda Prine MD, Mark A. Goedecker, MD, Mark Deutchman MD

and Laura Stein MD

ObjectivesRole of the rural physician in contraceptionAssessing the patient’s desire and need for

contraceptionNon-Hormonal contraceptionHormonal contraceptionEmergency contraceptionIUD video and labImplant video and lab

Role of the rural physician in contraception

Office practice: individual patient visitsConsultant to health departmentInformation to concerned community members

ParentsSchoolsReligious groupsNews media

Overall: improve access to contraceptive information and direct services

Opportunity for health promotion and life skills counseling

Assessing the patient’s desire and need for contraception

Full-time vs sporadic Long term vs short term STI protection Sexuality concerns Others………………

Background: Importance of Contraception

Unintended pregnancy

Nearly half of pregnancies in the United States are unintended.

Approximately 6.4 million pregnancies per year

Unintended, occur after

desired family size reached -

20%

Intended - 51%

Unintended, occur earlier

than desired - 29%

Outcomes of Unintended PregnanciesApproximately 3.0 Million Annually

Most unintended pregnancies occur when women fail to use contraceptives or

use their method inconsistently.

Half of women at risk are not fully protected from unintended

pregnancy.

28 million U.S. women at risk for unintended pregnancy

Consistent, long-acting

method use - 50%

At-risk gap use - 15%

Inconsistent use - 27%

Nonuse all year - 8%

Unintended pregnancy rate by race/ethnicity/income

0

20

40

60

80

100

120

140

160

180

Below poverty level Above poverty level

all

white

latina

black

Unintended pregnancies per 1,000 women

What are the lifetime considerations of unintended pregnancy ?

How many can you think of?

Efficacy of Contraceptive Methods

Efficacy of “Less Effective Methods”

85%85%No methodNo Method

3%14%Male latex condoms

5%21%Female condoms

9%-26%20%-40%Cervical cap

620%Diaphragm

Perfect-Use Rate of Pregnancy

Typical-Use Rate of Pregnancy

Family Planning Method

Effectiveness Group

1%-9%20%Fertility Awareness

4%19%Withdrawal

6%26%Spermicide

Less effective

Efficacy of “Effective Methods”

Perfect-Use Rate of Pregnancy

Typical-Use Rate of Pregnancy

Family Planning Method

Effectiveness Group

0.1%-0.5%Unknown (8%)Vaginal ring

0.3%-0.8%Unknown (8%)Transdermal patch

0.1%-0.5%8%Birth control pills

Effective

Highly Effective MethodsNot User-dependent

0.3%0.3%Hormone shot

Perfect-Use Rate of Pregnancy

Typical-Use Rate of Pregnancy

Family Planning Method

Effectiveness Group

0.6%-1.5%0.8%-2%Intrauterine

devices

0.1%0.1%Implants

0.1%-0.5%0.2%-0.5%Male and female

sterilization

Highly Effective(for all users)

Hormonal ContraceptionCombination estrogen/progesterone pillsSequential estrogen/progesterone

BiphasicTriphasic

Progesterone onlyPills, Injection and subcutaneous capsule

Extended cycleTransdermal patchesVaginal ringHormone-containing IUD

How do Oral Contraceptives Work?

Suppress, but not eliminate ovulation (Decrease FSH and LH by pituitary suppression)

Thin the endometriumThicken cervical mucous

Hormonal Contraceptives What is needed before prescribing pills?

Medical historyREQUIRED

Blood pressureRECOMMENDED

Pap smear

Pelvic/breast exam

STI testing

Hemoglobin

NOT REQUIRED

Estrogens in OCP’sMost pills use ethinyl estradiol (EE) as their

estrogen (50 µg mestranol = 35 µg EE)Doses range from 20 µg – 50 µg, but most are

20 µg – 35 µgLower dose estrogens have the benefits of less

bloating and breast tenderness but may increase the rate of breakthrough bleeding especially in obese patients

“Older” vs. “Newer” ProgestinsNewer:

Less androgenic (minimizes side effects such as acne, hirsutism, nausea, and lipid changes)

Increase progestational effectsLevonorgestrel is the most androgenic available

in USFirst, second, third, and fourth generation

progestinsEstranes and gonanes

“Newer” ProgestinsMinimal androgenic effectsNorgestimate

Increases HDL and decreases LDLDesogestrel (etonogestrel)

Possible increase risk in venous thromboembolism (VTE)

(Jick S et al. Contraception 2006:73:566-70. SORT B)Drospirenone

Antimineralocorticoid activityTheoretically could cause hyperkalemiaEssentially no androgenic activity

Monophasics vs. Biphasics vs. TriphasicsThere is insufficient data that biphasic or triphasic

combined oral contraceptive pills are better than monophasic pills (effectiveness, bleeding patterns, or discontinuation rates)

SORT B

Cochrane Database of Systematic Reviews 2007 Van Vliet HAAM, Grimes DA, Lopez LM, Schulz KF, Helmerhorst FM. Triphasic versus monophasic oral contraceptives for contraception

Van Vliet HAAM, Grimes DA, Helmerhorst FM, Schulz KF. Biphasic versus monophasic oral contraceptives for contraception

Choosing the Right PillLow androgenic activity is desirable in most if not

allIf patient weighs more than 160 pounds consider

higher estrogen and progestin activityLow dose estrogen if:

History of nausea, edema or hypertension in pregnancy

Uterine fibroidsFibrocystic breastsHeavy mensesMigraines

Choosing the Right Pill

Low progesterone if: History of preeclampsia, excessive weight gain,

tiredness, or varicose veins during pregnancy, Depression Excessive premenstrual

If history of polycystic ovaries, high progestational and low androgenic

Hormonal ContraceptivesWhich women/teens can’t use estrogen?

Estrogen contraindications: • Migraine with aura• Uncontrolled hypertension• Postpartum < 6 weeks• History of DVT

Smoking: NOT a contraindication in women/teens under age 35

Newer Oral Contraceptive Pills on the Market

Femcon Fe®

The new name for Ovcon Fe chewableChewable spearmint flavored tabletEE 35 µg, norethindrone 0.4 mg (21 days)Placebo contains 75 mg ferrous fumarateADVANTAGE: For those who cannot swallow

pills (and need fresh breath)

Yaz 24/4®

Same ingredients as Yasmin but…EE 20 µg (instead of 30 µg)3 mg of drospirenone24 days of active medication and 4 days of placebo

(as compared to the usual 21/7)ADVANTAGE:

Has an FDA indication for premenstrual dysphoric disorder (the only hormonal contraceptive with this)

Shorter periods

Loestrin 24 Fe®

24 days of hormones (similar to Yaz 24/4®)EE 20 µg, Norethindrone 1 mgPlacebo pills contain ironADVANTAGE:

Periods last less than 3 daysMore pronounced suppression of follicular

development

Extended Cycle Regimens

Extended Cycle ContraceptivesSeasonale®, Seasonique®, Lybrel®

Oral contraceptives taken continuously for more than 28 days compare favorably to traditional cyclic oral contraceptives (bleeding, discontinuation rates, and reported satisfaction)

SORT A

Edelman AB, Gallo MF, Jense JT, Nichols MD, Schulz KF, Grimes DA. ContinuousOr extended cycle versus cyclic use of combined oral contraceptives for contraception.

The Cochrane Database of Systematic Reviews 2007 Issue 2

Seasonique®

Like Seasonale®:EE 30 µg, levonorgestrel 0.15 mg for 12 weeks

But…13th week contains EE 10 µg (instead of placebo)

ADVANTAGES:Low dose EE may reduce hormone withdrawal

symptoms (migraines and dysmenorrhea)May cause less breakthrough bleeding then with

Seasonale (main reason women stop Seasonale)

Lybrel®Taken in a continuous 365-day regimenEE 20 µg and levonorgestrel 0.09 mg28 pills in a packFDA approved and will be released July 2007ADVANTAGE:

No menstrual bleedingDuring the 13 pill pack:

59% of women achieve amenorrhea 20% of women have spotting only 21% of women required sanitary protection due to breakthrough

bleeding• http://www.drugs.com/newdrugs/fda-approves-lybrel-first-low-combina

tion-oral-contraceptive-offering-women-opportunity-period-free-491.html?printable=1

Contraindications to Combined Oral Contraceptives

Unexplained VTE or VTE associated with pregnancy or exogenous estrogen use (unless on anticoagulants)

Women age 35 and older who smokePoorly controlled diabetes or diabetes with

complications such retinopathy, nephropathy, or other vascular complications

Level AUse of hormonal contraception in women with coexisting medical conditions. ACOG

Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

Contraindications to Combined Oral Contraceptives

OCP’s should be stopped one week prior to surgery or heparin prophylaxis should be considered

Women with CAD, CHF, or cerebral vascular disease

Use caution in obese women over the age of 35Poorly controlled HTN (or complications)Patients with Factor V Leiden gene mutation or

prothrombin gene mutationsLevel B

Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists.

Obstet Gynecol 2006: 107:1453-72.

Patients Who it is OK to Use OCP’s

Benign breast disease or family history of breast cancer

Mild lupus with no antiphospholipid antibodies

Level A

Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists.

Obstet Gynecol 2006: 107:1453-72.

Patients Who it is OK to Use OCP’s

Healthy, non-smoking women can continue their OCP’s until age 50-55

Well-controlled HTN <35 who do not smoke and are healthy

Well-controlled DM <35 who do not smoke and are healthy

Women with migraines who are healthy, do not smoke, and have no focal neurologic signs

Women with depressive disordersLevel B

Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists.

Obstet Gynecol 2006: 107:1453-72.

Estrogen / Progestin Patch

• 1 patch weekly for 3 weeks, then one week off• Same efficacy & contraindications as OCs• OK to shower, swim, exercise with patch on• Failures in trials were in women over 198

pounds, but still rare• Higher risk of clots? Conflicting studies…

Gallo MF, et al. Cochrane Reviews. 2003, Issue 1. Art. No. CD003552.Jick S, et al. Contraception 73 (2006)

Ortho Evra® Transdermal Contraceptive Patch

EE 20 µg/d and norelgestromin 0.15 mg/d One patch weekly for three consecutive weeks

followed by one patch-free weekMean serum concentrations are not affected by

heat, humidity, exercise or cold-water immersionContraceptive failure is higher in women with body

weight >90 kg

Ortho Evra® Transdermal Contraceptive Patch

Possible increased risk of venous thromboembolism (VTE) This is due to the increased serum concentrationPeak serum estrogen concentration is 25% less than

the peak level with the pill (30 µg)But women with the patch are exposed to 60% more

estrogen than taking the pillNuvaRing – 3.4 times less estrogen exposure than

patch and 2.1 less than the pill

Thacker H, Falcone T, Atreja A, Jain A, Harris CM. How should we advise patients about the contraceptive patch given the FDA warning?

Cleveland Clinic Journal of Medicine 2006: 73(1): 45-47.

The Patch and VTETwo-fold increase in the risk of VTE versus

norgestimate-containing oral contraceptives with 35 µg of EE

Overall, the number needed to harm (NNH) was 4,444 (AMI, VTE, stroke)

There is a five-fold increase in risk of VTE in pregnancy

There is no increased risk for acute myocardial infarction or stroke

Cole J, Norman H, Doherty M, Walker A. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users.

Obstet Gynecol 2007: 109(2):339-46.

Injectable ContraceptivesOnly one currently available is Depo-Provera®

Lunelle® was withdrawn from the US due to lack of demand and a recall (half-filled syringes)

Depo-Provera®

Medroxyprogesterone 150 mg given IM every 11-13 weeks

New Depo-subQ Provera 104®

Given every 12-14 weeksCan be administered by the patient in the thigh or

abdomenSide effects are similar

Slow return to fertility (14 weeks to 9 months)Irregular bleedingShort-term loss of bone mineral density

Depo-Provera® and Osteoporosis

FDA has required a black-box warning since 2004

“only use as long-term birth control method(>2 years) if other methods inadequate”

It has not been associated with postmenopausal osteoporosis or fractures

Society for Adolescent Medicine, ACOG and WHO have recommended continuing Depo after appropriately counseling

Estrogen/progestin vaginal ring

• Active for at least 3 weeks

• Lowest estrogen dose: 15 mcg / day

• Same efficacy and contraindications as OCs

• May remove for up to 3 hours

• QuickStart same as with OCs

NuvaRing®

EE 15 µg/day and etonogestrel 0.12mg/dayInserted into vagina and left in for three weeksRemoved for one weekCan be re-inserted if it has been out for less than

three hours (rinse with cold or warm water, not hot)

8/10 partners do not feel the ring during intercourse (can removed prior to intercourse)

http://www.nuvaring.com/HCP/PrescribingNuvaRing/StartingYourPatients/index.asp

Progestin Implant

• Highly effective and rapidly reversible• Discreet• Not user-dependent• Contain no estrogen• Can be used during lactation• Active hormone:

etonogestrel (68 mg)

Reinprayoon. Contraception 2000Diaz. Contraception 2000

Features of Progestin Implants

Causes spotting

Requires certified clinician visits for insertion and removal

Implantable Contraceptives

Norplant® was on the US market from 1991-2002Six rods containing levonorgestrelSeveral class action law suits over:

Failure to disclose side effects (irregular bleeding)Difficulty removing rods

Implantable Contraceptives

IMPLANON™ released August 2006One rod containing etonogestrelCan be left in for up to three yearsOnly providers who have completed a

“comprehensive practical training session” can insert IMPLANON™ (sponsored by Organon)

www.implanon-usa.com

IMPLANON™

Mean insertion time 1.3 minutes (range 1-15 minutes)

Mean removal time 3.8 minutes (range 1-60 minutes)

4 cm long and 2 mm in diameter

Nexplanon ™Etonogestrel

Emergency Contraception:Levonorgestrel (Plan B®)

Take at once, up to 5 days after unprotected sex.Lowers risk of pregnancy by 58-89%

Levonorgestrel EC:Mechanism of Action

Inhibits ovulation

Does NOT cause abortion

Ulipristal acetate: a new emergency contraceptive option

Decreases risk of unintended pregnancy by about 90%

Maintains nearly full efficacy up to 5 days after unprotected intercourse

Intrauterine Devices

IUD Myths Debunked

•IUDs can be used safely by nulligravid women and teens!

•IUDs DO NOT raise risk of PID.

•IUDs DO NOT raise risk of infertility.

•IUDs DO NOT raise risk of ectopic pregnancy.

IUD Myths Debunked• IUDs DO NOT cause abortion.

• OK to insert IUD at any point in the menstrual cycle.

• OK to insert immediately post-partum or following surgical abortion

• OK to test for STIs at time of insertion (& treat infections with IUD in place)

Progestin IUD (Mirena®) and Copper IUD (ParaGard®)

Lost Your IUD?(Can’t feel the string? Look with ultrasound !)

Sagittal view Transverse view

Counseling to Enhance Adherence

LISTEN to her ideas about the best method.

EXPLORE lifestyle issues that may impact adherence.

ENCOURAGE her to call you with problems/concerns.

Inconsistent pill use is linked to:low level of satisfaction with provider &

low continuity of care.

Percent of pill users who missed one or more pills during the past three months

34

47

36

51

0

10

20

30

40

50

60

Very satisfied w/provider

Not very satisfied w/provider

Usually see sameclinician

Do not usually seesame clinician

Office barriers to adherence

Feeling unable to call a provider with questions is linked to contraceptive non-use.

% of at-risk women experiencing contraceptive non-use in the past year

Take-home message:Be pro-active with contraception!

DE-LINK pap smears from birth control prescriptions.

ROUTINELY prescribe 1-year supply with 3 packs at a time.

Use Quickstart.

Ask about contraceptive needs at all types of visits.

Emphasize high-efficacy methods, but honor women’s choice whenever possible.

References and Resources• Hatcher et al, Contraceptive Technology 2007• Managing Contraception – book online @

www.managingcontraception.org• Medical Eligibility Criteria for Contraceptive Use 2010 by WHO http

://www.who.int/reproductivehealth/en/ • Association of Reproductive Health Professionals www.arhp.org • Alan Guttmacher Institute www.agi-usa.org• Planned Parenthood www.plannedparenthood.org• The Cochrane Collaboration www.cochrane.org• www.Not-2-Late.com or http://ec.princeton.edu/ • Reproductive Health Access Project www.reproductiveaccess.org