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1 10/11/17 1 Contraception Update for the Modern Day Woman Patti Wheaton, APRN, CNP Disclosures No commercial affiliations Just a proud new grandmother Learning Objectives To become more aware of the history of contraception To be able to provide a brief contraceptive overview to patients Increase awareness of potential new male contraceptives

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Page 1: Disclosures - cdn.ymaws.com...Various forms -gels, suppositories, foams, sponge 71-85% effective (typical to perfect use) Must be inserted each time prior to intercourse ... First

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Contraception Update for the Modern Day Woman

Patti Wheaton, APRN, CNP

Disclosures●No commercial affiliations●Just a proud new grandmother

Learning ObjectivesTo become more aware of the history of contraceptionTo be able to provide a brief contraceptive overview to patientsIncrease awareness of potential new male contraceptives

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Objectives (Cont'd)To gain greater understanding of hormonal and non-hormonal contraceptivesMechanisms of actionPrescribing SpecificsPotential side effectsContraindicationsEffectivenessSuggested patient educationClinical Pearls

Contraceptive History

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Ancient Egyptian writings from 1850BC refer to techniques using vaginal suppositories consisting of crocodile dung and fermented dough as well as plugs of gum, honey and acacia

Writings of Soranus of Ephesus in early 2nd

century Rome referred to vaginal sponges of wool infused with acidic concoction of fruits and nuts

And so it goes......

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Why Should We Initiate the Conversation about Contraception?

How Are We Doing?

We Need to Present the Options

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Start the Conversation

When you review a patient's history initially or at follow up appointments, ask about contraceptionMany women don't consider their contraceptive method a medication and don't include it in their medication listIs there a question about contraception on your patient history forms?

Consider Your Patient's Needs

Are you considering a pregnancy? When ?How important to you is it to not get pregnant?What have you used in the past that worked well for you?Have you completed your child bearing?Consider their lifestyle and how that would affect their method choices

Contraception Hits Home

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Behavioral Methods

WithdrawalPeriodic AbstinenceLactation AmenorrheaContinuous Abstinence

Withdrawal73-96% Effective (typical to perfect use)Requires high level of trust and self controlMay fail if there is sperm in the pre-ejaculateNo cost and always availableNo protection against STDs and HIV

Periodic AbstinenceAKA – Rhythm and Fertility Awareness

75-88% effective (typical to perfect use)Involves tracking basal body temperature and checking consistency of cervical mucusMust track menstrual cyclesAbstain or use barrier method 5 days before ovulation and 2 days afterMust have regular and predictable cyclesUsing more than 1 method increases effectivenessNo protection against STD's, HIV but no side effects

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Lactational Amenorrhea95-98 % effective (typical to perfect use)Breastfeed exclusively a minimum of every 4 hrs during the day and every 6 hrs at nightMust discontinue if any one of the following occur6 months postpartum1st period comesLess frequent feedingsNo periodsNo protection again STD's or HIV

Continuous Abstinence

Completely refraining from intercourse100% effectiveNo side effectsNo costPrevents STDs and HIV

Only works if you use it!

Barrier Methods

Male CondomFemale CondomDiaphragmCervical CapSpermicide

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Male Condom85 to 95% effectiveness (typical to perfect use)ConsLoss of sensationInconvenience and interruption of sexual intercourseSlippage or breakageProsHelp protect against STDs and HIVPEARLUse water based lubricants only

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Female Condom75-95% effective (Typical to perfect use)Lubricated polyurethane pouch inserted into vaginaProsHelps prevent HIV and STDsConsLoss of sensationInconvenience and disruption of intercourseHigher rate of slippage and breakage than male condomsFriction and noise during intercourse

Diaphragm and Cervical Cap84-94% effective (typical to perfect use)Must be fitted and prescribed by trained clinicianMust be coated with spermicide and inserted prior to

intercourseSubsequent episodes of intercourse within 6 hrs require

insertion of more spermicide with device still in placeMust be willing and able to locate cervix successfullyConsPossible skin irritationIncreased risk of UTI with diaphragmPossible increased risk of HIVDoesn't protect against STDs and HIV

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Spermicide

Various forms - gels, suppositories, foams, sponge71-85% effective (typical to perfect use)Must be inserted each time prior to intercourseAttacks the flagella and body of sperm, reducing mobility

and fructolytic activity, inhibiting nourishmentNo longer thought to protect against STDs and HIVProsAvailable over the counterConsPossible skin irritationMay actually increase risk of HIV transmission

Permanent Methods

MaleVasectomyFemale Bilateral Tubal LigationFallopian Tube Implants (Essure)

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Vasectomy99% EffectiveOutpatient or office procedure with local anesthesiaIncision or puncture into scrotal sacTransection of Vas DeferensOcclusion of both ends with suture ligation or cauteryMust use backup method until a “0” sperm count,

usually rechecked at 12 weeks postopRisks – hematoma, bleeding, swelling, infection, pain,

bruising, sperm granuloma (1-2% risk)No protection against STDs or HIVConsider post procedure regret, especially in younger men

Bilateral Tubal LigationBilateral fallopian tubes blocked with clips, bands,

segmental destruction with cautery or suture ligation and/or partial salpingectomy10 yr failure rate varies by methodClip 3.7%Bipolar coagulation 2.5%Interval partial salpingectomy 2%Silicone rubber bands 2%Postpartum Salpingectomy 0.8%ProsNo hormonesNo change in libidoNo effect on breastfeedingUsually outpatient

Bilateral Tubal Ligation (cont'd)ConsGeneral or regional anesthesiaUsual surgical risksPost procedure regret can be greater in younger womenNo protection against STDs or HIVOccasionally becomes more involved procedure from

laparoscopic to mini-lap with small incisionTimingPost C/S through the same incisionPost delivery with mini laparotomyInterval -doesn't coincide with recent pregnancy

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Fallopian Tube Implants (Essure)Microinserts via hysteroscope into each fallopian tube as

an office procedure, using local to general anesthesiaCreates scar tissue, blocking tubes after about 3 monthsMust use backup method until confirmation of occlusion

via hysteroscopy at 3 months post procedureFailure rate at 5 yrs is < 1:1000ProsNo hormonal influenceNo impact on libido, breastfeeding or periodsConsIncorrect placement can cause pain, bleeding and may

require surgical removalNo protection against STDs or HIVPost procedural regret for younger women

September of 2015, FDA investigated patient claims of harm secondary to the Essure

No evidence of wrongdoingSuggested the company evaluate their long-term outcomes

and provide additional training to cliniciansNew labeling now includes recommendations for patient

selection process with a checklist

Http://www.fda.gov/Medical/Devices/ResourcesforYou/Industry/UCM529254.htm

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Emergency Contraception

Use of drug or device to prevent pregnancy after unprotected intercourse

Candidates

Reproductive aged women having unprotected sex less than 120 hours previously

Independent of menstrual cycleNo absolute contraindications due to the short lived

hormone exposure2 methods available in US

Copper T380 IUDEmergency contraception pills

Copper T380 IUDCan be inserted up to 5-7 days after unprotected sexReduces risk of pregnancy by more than 99%Nearly 100% effective if inserted within 5 days of

unprotected sexConsSlight but transient risk of infectionHeavier, more painful periodsNo protection from STDs or HIVDiscomfort at the time of insertion, shortly afterCan have limited availabilityProsAlso provides excellent long acting contraceptionNo change in effectiveness with obese patients

Emergency Contraception Pills

Progestin OnlyProgesterone Agonist/AntagonistCombined Hormone

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Progestin Only – Plan BDelays ovulation up until the point of LH surge by

inhibition of follicular development and maturationIf taken within 72 hours of unprotected sex, the risk of

pregnancy is reduced by 89%ProsNo prescription requiredConsLess effective over 72 hoursLess effective if patient is > 165lbsGeneral Side Effects – all Plan B

Nausea/Vomiting HeadachesChanges in Menses DizzinessBreast Tenderness Abdominal Pain

Plan B One StepApproved by FDA in June 2013 as nonprescription

productNo age restrictionsConsists of enteric coated 1.5mg tablet of levonorgestrelGeneric available February 2014My WayTake ActionNext Choice One-Dose

Original Plan B1 dose of 750mcg Levonogrestrel as soon as possible after

unprotected sexRepeat no later than 72-120 hrs after unprotected sex Most effective at 72 hrs

Progestin Agonist/Antagonist Ulipristal Acetate - Ella

Effects agonist and antagonist receptors of progesteronePossible mechanism of action includes delaying or

preventing ovulation and changes of endometriumReduces risk of pregnancy by 90% if taken within 5 days

of unprotected sexLess reduction of effectiveness over time than other

emergency contraception pillsMay be less effective for obese womenIf vomiting occurs within 3 hours of administration,

repeat doseSide Effects: Headache, dizziness or abdominal Pain1 30mg tablet within 120hrs of unprotected sex

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Combined Emergency Contraception Pills

Yuzpe Regimen one of the 1st methods but less common nowTaking additional doses of oral contraceptives, usually

from existing prescriptionVarious methods available – www.bedsider.orgIf taken within 72hrs of unprotected sex, pregnancy risk

is decreased by 75%May be contraindicated in women with cardiovascular

risk factorsSide Effects – nausea, vomiting, head/ache, changes in

cycle, breast tenderness

Emergency Contraception FYIWon't disrupt an existing pregnancyNot intended to be used as an ongoing contraceptive

methodEffectiveness can be influenced byTiming of LMP and day of exposureRegular verses irregular periods and the effects on

ovulation timingExisting pregnanciesIf greater than 1 episode of unprotected sexPEARL – taking anti-emetic 1 hr before helps prevent

nausea and vomiting

Long Acting Reversible ContraceptionLARC

Intrauterine DevicesHormonalNon-hormonalImplants

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IUDsTiming of insertionImmediately postpartum or post AB up to 6wksCan be inserted at anytime in cycle that pregnancy can

be reasonable excludedCopper IUD can be used as emergency contraception5% risk for expulsion in 1st year if inserted immediately

postpartum or post ABCommon Side EffectsIrregular bleeding up to 6 months post insertionCramping, backache at time of insertionRisks of uterine perforation at insertion is 1%

Contraindications to IUDs

Copper IUD – Wilson's DiseaseUndiagnosed uterine bleedingKnown or suspected pregnancyActive cervical or endometrial infectionsAbnormal or distorted uterine cavityCons

Must be inserted or removed by trained clinicianNo protection against STDs or HIVPros

Rapid return to fertilityProtection immediately and can be removed at any timeAlways protected, nothing to remember

Nonhormonal IUDs

Copper T380 – ParagardIntroduced in 1988Offers 10 yrs of protection against pregnancyCreates a toxic intrauterine milieu,, preventing

fertilizationNo effects on breastfeedingCan be used in women with contraindications to

hormonal contraception99% effective in preventing pregnancy

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Hormonal IUDsT shaped IUD with levonorgestril

Mechanism of ActionChanges cervical mucus, altering sperm migrationUterotubal fluid and motility changes inhibit sperm

migrationEndometrial suppressionFirst – Was Progestasert, good for 1 yr, no longer availableCurrently availableMirena –52mg providing 20mcg per day x 5yrsLiletta –52mg providing 19.5mcg per day x 4yrsKyleena –19.5mg providing 17.5mcg per day x 5yrsSkyla – 13.5mg providing 14mcg per day x 3yrsMirena has FDA approval for menorrhagia

0.1% Failure rateNo adverse systemic effectsDecreased risks of endometrial and ovarian cancersDecreases menstrual flow and cramps.Approximately 20% experience amenorrhea 6 to 12

months after insertionRisks of PID decrease after first few months of use

compared to noncontracepting women

IUD PearlsTeach patient to check her strings after periods as the

greatest risk of expulsion is with bleedingLeave the strings longer – about 4cms – they will curl

around the cervix and not irritate her partner's penisScreening for GC, chlamydia and pap smears can be

done at the time of insertion. If GC or chlamydia (+), treat with the IUD in place

If pregnancy occurs with IUD in place, it is more likely to be ectopic but still lower rate than noncontracepting women

If pregnancy occurs, removal of the IUD decreases the risk of spontaneous AB from 50% to 25%

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ImplantsNexplanon Ethylene vinyl acetate copolymer rod, 40mm long, 2mm

in diameterContains 68mg etonogestrel, releasing a steady daily doseEffective for 3 yrsFailure rate of 0.2% the first year to 0.5% by the thirdSuppresses LH surge, suppressing ovulation, changing

cervical mucus and endometriumMust be inserted and removed by certified clinician

Pros

Quick, easy insertion in office, usually well toleratedDiscreet for patientFertility returns shortly after removal

Cons

Requires insertion and removalNo protection against STDs and HIVSide effectsHeadaches Weight gain

Acne Mood changesFacial hair Irregular bleeding

Also FDA approved is Norplant II, good for 5 yrs, but not marketed in US yet, available in other countries as Jadelle

Hormonal Contraceptives

Progestin OnlyPillsInjections

Estrogen and ProgestinPillsRingPatch

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Progestin Only PillsPOPs or Mini Pill

Monophasic pills with NO inactive pills75Mcg norgestrel or 350mcg norethindrone92-99% effective (typical to perfect use)Mechanism of Action

Changes the cervical mucus, causes atrophy of endometrium, affects motility in fallopian tubes

May suppress ovulation by decreasing LH and FSH peaksPros

Rapid return to fertilityDecreases flow, PMS s/s and cramps

Cons

Should be taken at the same time every dayIf more than 3 hours late, abstain or back up method for

7 daysCommon Side Effects

Spotting Decreased libido DepressionHeadaches Hair or skin changes

Pearls

Usually 2 bleeding patternsIf amenorrhea or irregular bleeding, ovulation is being

suppressedIf regular cycles, ovulation is occurring and patient may

want to abstain or use back up method mid cycle

InjectionsDepo Provera or DMPA

Synthetic depomedroxyprogesterone acetateFailure rate of less than 0.3% in 1st year of useEffective within 24 hrsMechanism of Action – suppresses ovulation by

suppression of LH and FSH and eliminates LH surge150mg IM or SubQ Provera is 104mg SQ every 3 monthsPros

Decreases risk for endometrial and ovarian cancerSafe with breastfeedingSafe for women who have contraindications to estrogenDecreases cramps

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Cons

Irregular bleeding for first 6 months50% will continue and 50% will have amenorrheaDelayed return to fertility – 70% by 12 months, 90% by

24 monthsWeight gain – if present at 6 months, there is a greater

risk for continued weight gainSide Effects

Weight gain Depression Irregular bleedingCan persist up to 1 year after use

PEARL

If prone to weight gain, most likely they will gain on DMPA

Black Box Warning

Significant bone mineral density loss possibleGreater loss with duration of useMay not be completely reversibleUnknown if use during adolescent or early adulthood

will affect future osteoporotic fracture risksOnly use longer than 2 years if other birth control

methods are inadequate

Counsel regarding diet and exercise to help maintain bone health

No bone density monitoring required

Combined Estrogen/Progestin Methods

3 Available forms: Pills, vaginal ring, transdermal patchPrimary mechanism of actionInhibition of ovulation by inhibiting LH and FSH.Alters tubal transport and the endometrial liningEffectiveness: 0.1 to 5% failure rate (typical to perfect use)

Common side effectsNausea Headache Amenorrhea

Breast tenderness Irregular bleeding Mood changesChanges in libido

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Drug Interactions

May need to be on a higher dose if on anticonvulsants, rifampin, Nuvigil, Provigil, griseofulvin. Check for a more extensive list – app discussed later

ProsDeceased cramps, flow, PMSReduced functional ovarian cystsPrevents functional ovarian cystsReduced benign breast diseaseReduced PIDAllows manipulation of timing of periodsDecreased epitheal ovarian cancer and endometrial

cancer

Cons

No protection against STDs and HIVMay take about 12 weeks to resume fertilityMust be used consistently – daily, weekly or monthlyPossible skin irritation with transdermal patchRing – must be comfortable with insertion and removalAbsolute Contraindications

CVA CHFPE

Smoker >35 >15 cigs/dIschemic heart disease Poorly controlled hypertensionBreast Ca – dx'd < 5yrs Undiagnosed vaginal bleedingMigraines with aura Known or suspected pregnancyMajor surgery with prolonged immobilization (stop 4-6 weeks prior to surgery)

Relative Contraindications

Migraines without aura, if over 35 or smokersSmokers over the age of 35, less than 15 cigs/dayPostpartum up to 3 weeks or 4 weeks breastfeedingBreast cancer diagnosed over 5 years previously

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Oral ContraceptivesCombination of ethinyl estradiol with progestin

Norethindrone levonogestrelnorgestril

negestimatedrospirenone desogestrilnorithindrone acetate ethynodial diacetate

Various combinations with estrogen in 35mcg or lessMonophasic, Biphasic, triphasicCan have 0 to 7 inactive pills at the end of the packPearl

Magic number with pills is 7Effective after 7 daysMiss or late with a pill, anything that interferes with absorption – abstain or b/u 7 days + duration

Vaginal Ring - Nuvaring92-95% effective (typical to perfect use)Nonbiodegradable, colorless flexible ring of a polymer of

ethyline vinyl acetate and Mg+ stearateOuter diameter 54mm, cross section 4mmEtonogestrel 11.7mg, ethinyl estradiol 2.7mg – released

120mcg/2.7mcg respectively, per day, absorbed vaginallyCan be use continuously, just change same day per monthQuick return to fertilityInsert in vagina, remove after 21 days, insert new ring in

7 daysPearlsLess n/v than oc's and no concerns about GI issuesIncreased vaginal secretions – perimenopause s/s7 day rule – if out of vagina > 3hrs, initially

Transdermal Patch – Ortho EvraTransdermal patch that gives 1 week supply of

norelgestromin and ethinyl estradial, changed weekly for 3 weeks with 1 week patch free intervalMay cause skin irritationMay be less effective in women over 198 pounds92-99% effective (typical to perfect use)FDA Warning 2005Patch released estrogen greater than expected and

increased risk of nonfatal thromboembolic events for patch is similar to 35mcg ethinyl estradiol and norgestimate combined ocsPearlConflicting data and with less contraversial options now

available, I just don't use it much anymore

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Noncontraceptive Benefits of Hormonal Contraceptives

MenorrhagiaPMSMenstrual MigrainesIron deficient anemiaHirsutismAcne (combined only)

DysmenorrheaEndometriosisIrregular mensesMenstrual flares of RAPCOSPerimenopause

Decreased Risks with Combined Hormonal ContraceptivesOvarian CancerOsteoporosisColorectal CancerEndometrial Cancer

HOPEIs not a method

Prescribing Resources

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The Future – Male Contraception

Vasalgel

Considered reversibleGel injected into the vas deferens, then flushed out with

another injection when reversal is desiredUndergoing clinical trials in India

Injectable 2008 to 20121000Mg synthetic testosterone with 200mg norethisterone

enanthate, a progestin, given every 8 wksStudy was shut down early due to adverse events

Penetrating the Inpenetrable

University of Wolverhampton in UK, December of 2016Announced they developed a peptide that deactivates the

protein responsible for the ability of sperm to use its flagella to swim

Temporary effectiveness with rapid effectsSecured funding to start live animal testing in the next 2

to 3 yearsLooking at making it into a pill or nasal spray

Bimek SLV – the Switch

“Roughly the size of a gummy bear”

Developed by a carpenter named Clemens Bimek, patented in 2000Bimek had it inserted in

himself in 200930 minute office procedure

with local, implanting device under the skin near the vas deferensClinical trials were

expected to start Aug 2017

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References“Birth Control Types”. (2016, August 26). Retrieved

from http://www.emedicinehealth.com/birth_control_overview/article_em.htm

Burn, Janet (2017, February 9). “Male Birth Control Could Finally Take Shape as a Gel”. Retrieved from

http://www.forbes.com/sites/janetwburns/2017/02/09/male-birth-control-could-take-shape-as-a-gel/#6cc2cc7201c2a

Casey, F.E. (2017, September 11). “Contraception Overview”. Retrieved from

http://emedicine.medscape.com/article/258507-overview

“Contraception”. (2016, July 18). Retrieved fromhttps://online.epocrates.com/u/2911418/Contraception

“Scientists talk about penetrating the impenetrable at festive lecture”. (2016, December 06). Retrieved from

https://www.wlv.ac.uk/about-us/news-and-events/latest-news/2016/december-2016/scientiests-talk-about-penetrating-the-npenetrable-at-festive-lecture.php

Scutti, Susan (2016, November 1). “Male Birth Control Shot Found Effective, but Side Effects Cut Study Short”. Retrieved from

www.cnn.com/2016/10/30/health/male-birth-control/index.html