Options For Contraceptive Management Jennifer Pearson, M.D. U of M Medical School – Duluth Campus.

Options For Contraceptive Options For Contraceptive ManagementManagement

Jennifer Pearson, M.D.Jennifer Pearson, M.D.U of M Medical School – Duluth CampusU of M Medical School – Duluth Campus

• More than 3 million unplanned pregnancies a year in the US• 50 – 60% of unintended

pregnancies occur in women using contraception• Approx half of these end in

abortion

Facts

Patient factors to consider when choosing contraception:

• STD protection

• Efficacy

• Convenience

• Duration of action

• Reversibility and time to return to fertility

• Effect on uterine bleeding

• Risk of adverse events

• Affordability

Method effectiveness - theoretical effectiveness if used perfectly

User effectiveness - actual effectiveness when studied in a non-perfect world

Contraceptive Options

• Natural methods

• Barrier methods

• Hormonal methods

• Emergency contraception

• IUD’s

• Sterilization

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5

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15

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Natural Condom Diaphrgm Est/Prog Prog Pill Prog IM IUD

Method

User

Efficacy of Contraception Options%

exp

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Cost of Contraceptive Methods


• Natural methods

• Barrier methods



• IUD’s

• Sterilization

Natural MethodsMechanism

Avoid intercourse and/or ejaculation around time of ovulation to prevent conception from occurring

Natural Methods

• Requires female with regular, predictable cycles

• Both partners dedicated

• Can include some or all of these methods:– Withdrawal method

– Calendar Method: abstinence from intercourse from 5 days prior to 3 days after ovulation

– Basal body temperature

– Cervical consistency

– Other ovulation predictors

Natural MethodsOvulation Timing

• Ovulation generally 14 days “prior to” 1st day menses

• Avoid intercourse 5 days prior and 3 days after ovulation

• Determine cycle variability

• To determine fertile period:– Subtract 18 days from length of shortest cycle

– Subtract 11 days from length of longest cycle

• Abstinence during this fertile window

Natural MethodsBasal body temps

Natural MethodsCervical mucous

At time of ovulation cervical mucous is:–Most abundant

–Watery

–Has consistency of “egg whites”

Natural Methods

• Timing is everything!

• There may be long periods of abstinence


• Natural methods

• Barrier methods



• IUD’s

• Sterilization

Barrier MethodMechanism

Prevent sperm from fertilizing egg by use of physical and/or pharmacological barrier

Barrier Method

• Female condom• Male condom• Spermicide• Diaphragm• Cervical cap• Lea shield -

discontinued• Sponge

CondomsMale and Female

• BEST STD PROTECTION!

• Male condom more effective and more commonly used than female condom

• Effectiveness is highly user dependent

• Most effective if used with spermicide (nonoxynol-9)

CondomsMale

•Recommend using with other methods for STD prevention•How to use:

•Roll onto erect penis leaving ½ inch at tip to collect semen•Remove immediately after ejaculation and careful withdrawal

•Latex and non-latex options•Use with spermicide

•Use only with water-based lubricants

CondomsFemale

• Polyurethane• Can insert prior to sexual

activity and leave in a longer time after ejaculation• One time use• More slippage than male

condoms• STD protection when used

correctly• Less popular• More expensive

Diaphragm

• Requires fitting by a trained physician• Decreases (but does NOT prevent) STD’s• Use with spermicide• Insert up to two hours before coitus; must leave in

at least 6 hours after (not more than 24 hours total)• Increased rate of UTI’s• Latex• Must be re-fit if: more than 10# weight change;

pregancy since last fitting; pelvic surgery• Patient must be comfortable doing self exam

DiaphragmHow To Fit

Cervical Cap

• Fem Cap – silicone rubber• Must be fit by a trained provider• Comfort with self exam• Must leave in minimum of 6 hours after coitus (max of

48 hours total)• Harder to fit and to use• Option if patient is having problems with increased

UTI’s from diaphragm• Question of increased risk cervical dysplasia • Increased risk toxic shock

Cervical Cap

Lea Shield

• ** Discontinued**

• Silicon

• One size fits all

• One way valve

• Use with spermicide

• Leave in for at least 8 hrs post coitus

• Was available by prescription – Stay Tuned!

Sponge

• Discontinued in 1995, re-introduced in 2005

• “Today” sponge

• Circular disc with 1000 mg nonoxynol-9

• Moisten with tap water, insert deep into vagina and leave in place for up to 24 hours

• Less effective than other methods

• ? increased rate of toxic shock syndrome

Spermicide Formulations

• Foams, creams, jellies, suppositories

• Works by damaging cell membranes of sperm cells and bacteria

• Can cause topical irritation

• Best when used with condom or diaphragm


• Natural methods

• Barrier methods



• IUD’s

• Sterilization

Hormonal Methods

• Combined estrogen / progesteronePillRingTransdermal patch

• Progesterone onlyInjectionPillIUDImplantable

Combined Estrogen / ProgesteroneMechanism

Primary mechanism is estrogen-induced inhibition of the midcycle surge of gonadotropin secretion, so that ovulation does not occur

Combined Estrogen / ProgesteroneAbsolute Contraindications

• Previous thromboembolic event or stroke• Hx of CAD• Hx of estrogen dependent tumor• Liver disease• Pregnancy• Undiagnosed abnormal uterine bleeding• Smoker (>20 cigs/day) over age 35

Combined Estrogen / ProgesteroneRelative Contraindications

• Obesity

• Smokers over age 35 < 20 cigs/day

• Inherited thrombophilias

• Anticonvulsant therapy

• Migraine headaches

• Hypertension

• Depression

• Lactation

Combined Estrogen / ProgesteroneNon-contraceptive Benefits

• Reduction in dysmenorrea

• Reduction in menorrhagia

• Reduction of ovarian, endometrial, and colorectal cancers

• Improves acne

• Improves benign breast disease

• Improves osteopenia or osteoporosis

• Decreases functional ovarian cysts

• Decreases ectopic pregnancy rates

Combined Estrogen / ProgesteroneMedical Concerns

• Increase in thromboembolic events• Breast cancer risks – controversial and

unproven• Cervical cancer risks• Medication interactions

AntimicrobialsAnticonvulsantsAnti-HIV Herbal products

Combined Estrogen / ProgesteroneFormulation Options

•Oral– Monophasic

– Biphasic

– Triphasic

– Extended cycle

• Vaginal Ring

• Transdermal Patch

Combined Estrogen / ProgesteroneOral: “The Pill”

• Estrogen–Ethinyl estradiol with doses from 20-50 mcg

• Progestin–First and second generation: levonorgestel and

norethindrone

–Third Generation: norgestimate, desogestrel

–Spironolactone analogue: drospirenone


• Levonorgestel and norethindrone

• More androgenic than newer progestins

• Androgenic side effects :– Increased LDL and/or decreased HDL

– Acne

– Mood changes

– Weight gain

First and second generation progestins:


• Norgestimate and desogestrel– Less androgenic effect

» good choice for patients with dyslipidemia, acne or other possible androgenic SE’s

–Higher thromboembolic potential » 2-3 X higher than first or second generation

progestins

Third generation progestins:


Drospirenone–A spironolactone analogue

–Both mineralocorticoid & lower androgenic effects

–Potential benefits:

Improves weight stability/water retention

Improves other possible androgenic SE’s

–May increase serum potassium

Therefore contraindicated in certain patients

Combined Estrogen / ProgesteroneOral: “The Pill

• Monophasic– Same fixed dose for three weeks, then placebo week

• Biphasic and Triphasic– Varying doses through first three weeks then placebo week– Similar SE profile to monophasics

• Extended cycle (Seasonale / Lybrel)– Seasonale: 84 days fixed dose hormones then placebo week – Lybrel: Fixed dose of estrogen/progestin 365 days/yr– Breakthrough bleeding more common, but decreases over time– ? Whether increased amount of hormone exposure over time

will lead to greater long term side effects


How to prescribe “The Right” pill–Start with low to moderate dose estrogen with

most appropriate progestin considering co-morbid conditions

–Allow at least 2-3 cycles to assess

–Adjust based on side effects

– Follow-up based on side effects and co-morbid conditions


• Patient instructions on how to take pills:– First day of menses vs. Sunday start

–Same time of day every day

–Missed pills- what to do?

• Follow up:–Blood pressure check

–Side effects and overall tolerance of pills


Common side effects and what to adjust:–Breakthrough bleeding

In first 10 days - increase estrogenAfter 10 days - increase progestin

–No withdrawal bleedDo pregnancy testContinue pillsIf patient wants menses to return, can increase estrogen

– Typical “hormone related side effects”Adjust appropriate hormone component

Combined Estrogen / ProgesteroneVaginal Ring

• NuvaRing – 15 mcg ethinyl estradiol and 120 mcg of etonogestrel daily

• Worn intravaginally for three weeks, then out for one

• When to start• Instructions for if it falls out:

– If out <3 hours rinse and replace– If out >3 hours replace and use backup contraception– If in place between 3-4 weeks, give week off then replace– If in place more than 4 weeks, give one week off and use back

up contraception for at least a week once replaced

Combined Estrogen / ProgesteroneVaginal Ring

Comparison to Oral OCP’s:–Comparable efficacy– Lower doses of hormones–Rapid return to ovulation–Ease and convenience–Similar SE’s, contraindications–Plastic NOT latex–Cost is about twice that of OCP’s

Combined Estrogen / ProgesteroneTransdermal Patch

• Ortho Evra- 20 mcg of ethinyl estradiol and 150 mcg of norelgestromin daily

• Change once a week for 3 weeks then one week patch free

• How to start

• Apply to buttock, abdomen, upper arm or torso (not breast)

• Instructions if patch comes off

Combined Estrogen / ProgesteroneTransdermal Patch

Comparison to OCP’s–Similar efficacy overall

–Greater failure rate in women >90 kg.

–Better compliance

–More breakthrough bleeding, breast discomfort, dysmenorrhea, site reactions

– FDA warning that women are exposed to more estrogen with patch than with most OCP’s- ?clinical implications long term

Hormonal Methods• Combined estrogen / progesterone

PillRingTransdermal patch

• Progesterone onlyInjectionPillIUDImplantable

Progesterone OnlyMechanism

Primary mechanism is inhibition of ovulation. The progestin effect also causes changes in the endometrium and cervical mucous, resulting in decreased sperm transport and implantation.

Progesterone OnlyFormulations

• Oral (minipill)

• Injectable

• Implant

• IUD

Progesterone OnlyIndications

• Patients who want effective contraception but want or need to avoid estrogen:–Medical contraidications to combination

contraception

–Side effects to combo options that are prohibitory to using

–Nursing

• Prefer prescribing schedule

Progesterone OnlyIssues to consider

• Irregular bleeding

• Other SE’s from androgenicity

• Duration of effect and return to fertility

• Chance of breakthrough ovulation if “pill missed ” with oral formulation

• Effects on bone health

Progesterone OnlyNon-contraceptive benefits

• Eventual reduction of menstrual flow• NO increased risk of stroke, MI or

thromboembolic event• Reduced risk of endometrial

cancer and PID – With medroxyprogesterone acetate/Depo-

Provera

Progesterone OnlyOral Formulations- Minipill

Patient instructions:– First day menses vs. Sunday start

– Take daily, like combo pill at same time every day

–No withdrawal bleed week

– **Timing critical (within 3 hours) or backup contraception needed**

–Higher failure rate

Progesterone OnlyInjectable

• Medroxyprogesterone acetate (Depo-Provera)

• IM every 3 months

• Start within 5 days of first menstrual day

• Concern with bone health– Evidence for bone resorption and reduction in BMD

presumably due to induced estrogen deficiency

– Will normalize in healthy subjects once off DMPA

– Current labeling recommends limiting use to 2 yrs.

– If long term use necessary, BMD needs to be evaluated and followed

– Calcium and weight bearing exercise recommended

Progesterone OnlyImplants

• Rods implanted subcutaneously under skin- remove once no longer effective

• Norplant– Withdrawn

• Jadelle (levonorgestrel- 80-25 mcg per day)– Two rod system – effective for 5 yrs

• Implanon (etonogestrel – 40 mcg per day)– One rod system – effective for 3 yrs– FDA approved

Male Hormonal ContraceptionFuture developments

• In development phases

• Use testosterone + or – GnRH analogues or progestins to suppress spermatogenesis

• STAY TUNED


• Natural methods

• Barrier methods



• IUD’s

• Sterilization

Emergency ContraceptionDefinition

The Prevention of pregnancy within 72 hours of unprotected intercourse or failure of a contraceptive method (i.e., a broken condom)

Emergency ContraceptionMechanism For Hormonal Options

• Depending on timing within menstrual cycle, can inhibit ovulation or prevent fertilization

• Greater possibility of a post-fertilization effect–Endometrial changes inhospitable to a

fertilized ovum

Emergency ContraceptionFormulation options

• Plan B

• Using combo pill packs

• Other options not commonly used in US–Mifepristone

–Copper IUD placement

Emergency ContraceptionFormulations

Plan B– Progestin only

– Only one marketed and approved for emergency contraception use

– Gained OTC approval in 2006 (if age 18 or older)

– Less nausea and vomiting

– One tablet within 72 hours of unprotected intercourse, repeat with second tablet 12 hours later

Emergency ContraceptionFormulations

Using Combo pill packs (estrogen + progestin)–Depending on estrogen/progestin dose, taking 2

or 4 pills initially within 72 hours of unprotected intercourse, and repeating dose in 12 hours.

–May cause nausea therefore pre-medicate if necessary

Emergency ContraceptionIssues to consider

• Can reduce risk of pregnancy by 75-89%• Politically controversial• State/pharmacy variability

in availability


• Natural methods

• Barrier methods



• IUD’s

• Sterilization

Note: flower not included

IUD’s

• Copper IUD (ParaGard)– Mechanism: Pre-fertilization effect; induces foreign body

reaction in endometrium, with resulting inflammatory response preventing viable sperm from reaching fallopian tubes

– Effective for 10 years

• Slow release progesterone (Mirena-levonorgestrel)– Mechanism: Inhibits ovulation; Also inhibits sperm

survival and implantation– Non-contraceptive benefits: decreases menstrual blood

loss and relieves dysmenorrhea – Effective for 5 years

IUDIdeal Patient

• Parous

• Stable, monogamous relationship

• No hx PID, ectopic pregnancy, or condition predisposing to ectopic

• Williing to check for threads

IUDPatient Profile

Contraindications– Pregnancy– Hx ectopic pregnancy– Congenital or acquired uterine cavity malformation– Acute STD, cervicitis, or vaginitis– Current or prior hx PID– Postpartum endometritis or infected abortion within 3

months– Less than 8 wks postpartum– Known or suspected uterine or cervical neoplasia– Unresolved abnormal pap smear– Genital bleeding of unknown cause

IUD’sPatient Profile

Contraindications continued:– Multiple current sexual partners or a partner that is not

monogamous

– Acute liver disease

– Immunodeficiency states

– Hx previously inserted IUD that has not been removed

– Allergy to copper (for ParaGard)

– Known or suspected breast carcinoma

– Artificial heart valves

– Wilson’s disease (for ParaGard)

– Contraindications or sensitivity to levonorgestrel (for Mirena)

IUD’sHow to Insert


• Natural methods

• Barrier methods



• IUD’s

• Sterilization

Sterilization

• Should be considered permanent–Appropriate counseling and selection

–Reversible procedures do exist but come with limited success and many issues

• Two types:– Tubal ligation

–Vasectomy

SterilizationTubal ligation

• Definition:– Any procedure that prevents pregnancy by occluding or

disrupting tubal patency in the female

• Multiple techniques– Most require general or regional anesthesia

– Laparoscopic or hysteroscopic procedure

– Ligation and section removal, clips, rings, coils, plugs, cauterization

– Can do during Cesarean section or postpartum

– Essure or Hysteroscopic tubal ligation is newer techique

SterilizationTubal ligation

Other issues:–Main adverse effects are surgery related

– If pregnancy does occur, higher risk for ectopic (33%)

–Post tubal ligation patients at decreased risk for ovarian cancer

SterilizationVasectomy

• Definition:–Procedure that results in ligation of the vas

deferens

• How performed– In physician office under local anesthesia

–Safe, effective

–Multiple different variations of technique

SterilizationVasectomy

• Adverse effects–Mostly procedure related

• Post procedure follow up–MUST have semen analysis to assure no

motile sperm**

–Approx 20 ejaculations or 3 months following

–Need to use other form of contraception until cleared

• Risk / benefit ratio weighs in favor of vasectomy over tubal

ContraceptionEthical Issues to Consider

CASE #1

• 39 yo G2P2

• Postpartum visit

• Nursing

• Otherwise healthy

• Only meds are prenatal vitamins

• Doesn’t know if she wants third child

• Contraception options?

CASE #2

• 17 yo in for sports PE

• Sexually active– 2 previous partners

– Current boyfriend for 4 months

• Uses condoms “when they remember”

• Generally healthy– Irregualar menses

– Mild depression in past- not on meds


CASE #3

• 25 yo medical student

• Long term relationship

• One previous sexual partner, no history STD’s

• Hx migraine headaches otherwise generally healthy

• Wants to get through boards before talking marriage / future


CASE #4

• 44 yo G3P3003

• Married

• Hx of fertility problems; now “they’re careful”; “done” having children

• Overweight (5’4”, 185#)

• No hx STD’s

• Mild hypertension well controlled on low dose Ace inhibitor

• Hypercholesterolemia- on a Statin


CASE #5

• 37 yo G4P4

• On third marriage

• Hx PID at age 23

• Smokes 1 ½ packs per day

• Depression- on SSRI

• Currently using condoms


Options For Contraceptive Management Jennifer Pearson, M.D. U of M Medical School – Duluth Campus.

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