Combination Hormonal Contraceptive Methods: Identification of Candidate for Initial Start

COMBINATION HORMONAL CONTRACEPTIVE METHODS: IDENTIFICATION OF CANDIDATE FOR INITIAL START,

RESTART, or CONTINUATION

DEFINITION

Combination hormonal contraception with estrogens and progestins are available as oral contraceptives, once-a-week transdermal patches and once-a-month vaginal rings. This protocol is intended to describe the process for identifying women who may be eligible to use these methods. The basis for these recommendations is the 2010 US Medical Eligibility Criteria (US MEC) from the CDC. If used correctly and consistently, combined hormonal contraceptives have a first year failure rates of less than 1%, but in typical use, the first year failure rate for oral contraceptives is 9%. No data are available on the efficacy of the other delivery systems of combined hormonal contraception. Counseling is critical to successful use. Shortened pill free intervals and more generous dispensing patterns are associated with high continuation rates and lower pregnancy rates.

SUBJECTIVE

Mustinclude:

1. LNMPandPMP (prior menstrual period)

2. Medical,sexual,andcontraceptivehistory(initialorupdate). Include Review of Systems

Mustexclude:

Contraindications (CDC 3--Risks outweigh advantages for method use; CDC 4—Unacceptable risk for method use)

1.History of, or current, deep vein thrombosis(DVT)/pulmonary embolism (PE)(CDC 3, 4)

2.Stroke (history of cerebrovascular accident) (CDC 4)

3.Known thrombogenic mutations (e.g. Factor V Leiden, Prothrombin mutation, Lupus Anticoagulant, Protein C, Protein S, and Antithrombin deficiencies) (CDC 4)

4.History of, or current, ischemic heart disease (CDC 4)

5.Multiple cardiovascular risk factors(older age, smoking, diabetes, hypertension) (CDC 3,4)

6.Smoking ≥35 years of age

a.<15 cigarettes/day (CDC 3)

b.≥15 cigarettes/day (CDC 4)

7.Known hyperlipidemia (CDC 2,3) (consult with medical director)

8.Diabetes mellitus with nephropathy, retinopathy, neuropathy (CDC 3,4)

9.Vascular disease or diabetes of >20 years duration (CDC 3,4)

10.Viral hepatitis (acute or flare) (CDC 3, 4)

11.Liver tumor (adenoma or hepatoma) (CDC 4)

12.Cirrhosis-severe (decompensated) (CDC 4)

13.Solid organ transplant (complicated) (CDC 4)

14.Breast cancer (current—CDC 4); or (past--CDC 4)

15.Major surgery with prolonged immobilization (CDC 4)

16.Valvular heart disease- complicated (pulmonary hypertension, history of sub-acute bacterial endocarditis, risk of atrial fibrillation) (CDC 4)

17.Peripartumcardiomiopathy (CDC 3,4)

18.Hypertension

a.Adequately controlled (CDC 3)

b.systolic ≥ 160 or diastolic ≥ 100 (CDC 4)

c.systolic ≥ 140-159 or diastolic of 90-99 (CDC 3)

19.Gallbladder disease –symptomatic (current or medically treated) (CDC 3)

20.History of Cholestasis -(past COC related) (CDC3)

21.Post-partum (non-breastfeeding or breastfeeding) <21 days (CDC 4)

22.Post-partum (non-breast feeding or breastfeeding) 21 – 42 days with other risk factors for VTE (age ≥35 y.o., previous VTE, thrombophilia, immobility, transfusion at delivery, BMI 30 or >, post-partum hemorrhage, post cesarean delivery, preeclampsia, or smoker)(CDC 3)

23.Post-partum (breastfeeding) 21-30 days without VTE risk factors (CDC 3)

24.Systemic Lupus Erythematous—with positive (or unknown) antiphospholipid antibodies (CDC 4)

25.Medically Diagnosed Migraine

a.Without aura <35 years of age (CDC 2 for initiation; CDC 3 for continuation)

b.Without aura ≥35 years of age (CDC 3 for initiation; CDC 4 for continuation)

c.With aura-any age (CDC 4)

26.Inflammatory bowel (ulcerative colitis, crohns) (CDC 2,3)

27.Bariatric surgery (history of)-malabsorption procedures (CDC 3 for COC only)

Medically

OBJECTIVE

Mustinclude:

1. NormalBP.EvaluateifBPs≥140orBPD≥90.

2. WeightandBMI.

3. Nophysicalexamisneededforroutineinitiationofcombinedhormonalmethods.Examsmaybe neededtoevaluateproblemsraisedby reviewofsystemsorcomplaintsraisedby thepatient.

LABORATORY

1. Noroutinescreeninglabsarerequiredforhealthywomen.

2. Laboratorytestsmaybeneededforwellwomancareortoevaluateproblemsraisedby patient’s historyorcurrentcomplaints,butunlesstheyrepresentasignificantUSMEC condition,they shouldnotdelaypillinitiation.

3.Pap screening and clinical breast exam (based on current recommendations for timing and testing components).

4. Annual CT (GC if positive CT) for clients <25 years old (and older clients at high risk).

ASSESSMENT

Candidateforcombinationhormonalmethods,initialstart,restart or continuation.

PLAN

1. Ifpatienthasnocontraindicationstocombinationhormonalcontraceptivemethoduse, providethedeliverysystemthatbestmeetspatient’sneedsforcontraceptionandmaximizesher non-contraceptivebenefits.

a.Iforalcontraceptivepillsareselected:

1) Provideatleastoneyearsupplyofpills,unlesssheisplanningpregnancysooner.Follow- upvisitsmaybescheduledearlier,buttheneedforfollow-upshouldnotinfluencethe numberofcyclesprovided.

2) Determineifpatientpreferscyclicorextendedcycleuseoforalcontraceptives.

a) Ifshedesiresmonthlyscheduledbleeding,selectaformulation,consideringpatient preference,cost,andnon-contraceptivebenefits.

(1)Ifusinglowdoseformulationsorthepatientsuffersestrogen-withdrawal symptoms,considershorteningtheplacebopillintervalto3-4days.

(2)Triphasicformulationshavenoadvantage,ingeneral,overmonophasic

formulations.

(3)Thereisnostrong,consistentevidencethatoneprogestinisassociatedwith clinicallysignificantlyhigherrisksofVTEthanotherprogestins.All estrogen-containingpillshavelowerVTErisksthanVTErisksofpregnancyandthe postpartumperiod.

b) Ifthepatientpreferstoavoidscheduledbleeding,offerextendedcyclecombinedOC use.Providesuppliesofactivepillsto meethercontraceptiveneedsfor12 months (unlesssheisplanningpregnancysooner).Herscheduleoffollow-upvisits should not affectdispensingprotocols.Thiscanbedoneinoneofthefollowingways:

(1)Selectabrandedextendedcyclepillproduct.

(2)Providesuppliesof monophasiccyclicpillssufficienttoprovideuninterrupted activepilluse.Adviseuseofoneofthefollowingapproaches:

(a) Establishfixedintervalsofpilluseto mimicbrandedproducts(e.g.,84active pillsfollowedby 4-7daysofplacebopills).

2) Discusspillinitiationoptions.

a) Quickstart(Samedaystart)ispreferredapproach.

(1)Ifthepatientiswithin5daysofthebeginningofherlastmenses,sheshouldtake thefirstpilltoday.Noback-upmethodisneeded.

(2)Ifthewomanislaterinhercycle,initiationdependsuponwhethershehashad anyunprotectedintercourse.

(a) Ifshehashadnounprotectedintercourseinlast5days,sheshouldtakeher firstpilltoday.Advisehertouseabstinenceorabackupmethodforthenext

7 days.

(b)Ifthepatienthashadanyunprotectedintercourseinlast5days,provide appropriatehormonalemergencycontraceptive(SeeEmergency Contraception(EC)protocol).HavehertakeECtodayandtakethefirstpill inherpillpacktonightortomorrow.Advisehertouseabstinenceorbackup methodforthefirst7daysofpilluse.

b) Firstdaystartisalsoanoption.

(1)ProvidepatientanothercontraceptivemethodandECforhertouseuntilthe beginning of her next period.

(2)Tellhertostartherfirstpackofbirthcontrolpillsonthefirstdayofhernext menses.Shewillneednoback-upmethodonceshestartsherpills.

c) Sundaystartistheleastpreferredmethodofpillinitiation.

(1)ProvidepatientanothermethodofcontraceptionandECtouseuntilhernext normalmensesstarts.

(2)TellhertostartherfirstbirthcontrolpillonthefirstSundayofhernextmenses.

Makesuresheunderstandsthatsheshouldcountfromthefirstdayofbleeding, notthelastday.

3) Recommendpregnancytestnoworinthefirstcycleofpilluseifpatienthassymptomsof pregnancyorifherscheduledbleedingisdelayedorabnormal.

4) Counselpatientaboutmissedpills(seePatientEducation).

5) Providea12-monthsupplyofpills.(Note:forextendedcycleusers,a12-monthsupply requires17packetsofcyclicpills).

6) Advise patient to return to the clinic if needed (side effects, method utilization, method change desired) OR if provider feels it is clinically indicated. No routine follow up visit is required. (U.S. SPR pg. 26, reference 30).

b. Ifvaginalcontraceptiveringpreferred,

1) Determineifpatientpreferscyclicorextendedcycleuseofvaginalcontraceptivering.

a) Ifshedesiresmonthlyscheduledbleeding,

(1)Advisehertoplacethevaginalringasdiscussedbelowandremoveitin21days. Duringthe7ring-freedays,shewillhaveascheduledbleed.

(2)Sheshouldplaceanewring7daysaftersheremovedthefirstring,regardlessof whetherornotshehasfinishedbleeding.

b) Ifshepreferslessfrequentbleedingepisodes,sheshoulduseoneringfor28-30days andimmediatelyreplaceitwithanewring.

2) Discussringinitiationoptions.

a) Quickstart(Samedaystart)ispreferredapproach.

(1)Ifthewomanhashadnounprotectedintercourseinprior5days,sheshouldplace thecontraceptiveringinhervaginatoday.Advisehertouseabstinenceoraback- up methodforthenext7days,

(2)Ifthewomanhashadanyunprotectedintercourseinlast5days,havehertake hormonalemergencycontraceptivenow,unlesssheiswithin5daysofherLMP. (SeeHormonalEmergencyContraception(EC)protocol).Haveherplacethefirst ringinhervaginatodayortomorrow.Advisehertouseabstinenceoraback-up methodfornext7 days.

(3)Recommendpregnancytestnoworinthefirstcycleofringuseifpatientis

symptomaticorifherwithdrawalbleedingisdelayedor abnormal.

b) Firstdaystartisalsoanoption.

(1)ProvidepatientanothercontraceptivemethodandECtouseuntilhernext

menses.

(2)Tellhertoplacethefirstcontraceptiveringinhervaginaonthefirstdayofher nextmenses.Tamponscanbeusedwiththering,butthepatientmustcheckto insurethattheringisnotlostwheneveratamponisremoved.Noback-upmethod isneeded.

c) Sundaystartisnotanoptionbecausethevaginalringmustbestartedonthefirstday orwithinthefirst5daysofthewoman’scycle.

3) Providethepatientwithinstructionsabouthowtoplacevaginalringinupperaspectof hervagina,flatagainstthevaginalwall.Blunttippedtamponapplicatorscanbeusedto placethecontraceptiveringeasilyinthevault.

4) Tellthepatienttoremovevaginalring21-30dayslater.Placeringintotheoriginalpouch itcameinanddisposeofitinroutinetrash.Donotflushringdowntoiletorpressthrough trash compactor.

5) Ifringisexpelledorisremovedformorethan3hoursinany24hourperiod,she should

a) Replacetheringimmediately.

b) Useback-upmethodfor7days

c) SuggestusingEC,ifshehashadrecentintercourse.(SeeEmergencyContraception(EC)protocol.)

6) Providea3to12-monthsupplyofrings.Note:Ifmorethana 3monthsupplyis provided, advisepatienttostoretheringsintherefrigerator.

7) Advise patient to return to the clinic if needed (side effects, method utilization, method change desired) OR if provider feels it is clinically indicated. No routine follow up visit is required. (U.S. SPR pg. 26, see ref. #30).

c.Iftransdermalpatchisreferred:

1) Discusspatchinitiationoptions.

a) Quickstart(Samedaystart)ispreferredapproach.

(1)Ifthepatientisnotonthefirstdayofhercycle,recommendationsdepend upon whethershehashadanyunprotectedintercoursesinceherLMP.

(a) Ifthewomanhashadnounprotectedintercourseinprior5days, patient shouldplaceherpatchtoday.Advisehertouseabstinenceora backup methodforthenext7days.

(b)Ifthewomanhashadanyunprotectedintercourseinlast5days,provide appropriatehormonalemergencycontraceptive(SeeEmergency Contraception(EC)protocol).Haveherplaceherfirstpatchtodayor tomorrow.Advisehertouseabstinenceorabackupmethodfornext7days.

(2)Recommendpregnancytestnoworinthefirstcycleofpatchuseifpatientissymptomaticorifherscheduledbleedingisdelayedorabnormal.

b) Firstdaystartisalsoanoption.

(1)ProvidepatientanothercontraceptivemethodandECtouseuntilthefirstdayof hernext period.

(2)Tellhertoplaceherfirstpatchonthefirstdayofhernextmenses.Nobackup methodisneeded.

c) Sundaystartisnotanoption,sincethemethodmustbestartedonfirstdayof menses.

2) Discusspatchplacementinstructions.Patchisplacedonlowerabdomen,buttocks,back, fronttorso(exceptbreasts)orupperarm.

3) Instructthepatienttoremovehercurrentpatchandplacenewpatchondifferentlocation onappropriatebodyareasevery7daysuntilshehasusedatotalof3patches.Aftershe has removedher3rdpatch,sheshoulddelayplacementofanotherpatchfor7days,during whichtimesheshouldexperienceascheduledbleed.Tellhertoplaceanewpatchatend of 7daypatchfreeperiod.

4) Routineextendedcycleuseofthecontraceptivepatchisnotrecommended,butoccasional useof morethan3consecutivepatchesispermittedforspecial

circumstances.Extended use ofthepatchhasonlybeenstudiedforonetimeuseupto84days.Inthatstudy,itwas seenthattheserumlevelsofthepatchusersincreasedwithincreaseduse.

5) Useabstinenceoraback-upmethodfor7days,andconsideruseofECifanyintercourse occursaroundthetimeofanyofthefollowingpatchproblemsoccurs:

a) Patchseparatedfromskinformorethan24hours,

b) Patchplacedlate,

c) Patchesusedlongerthan9days,especiallyforfirstpatchinthecycle.

6) Provide12months’supplyofpatches.Scheduleoffollow-upvisitsshouldnotinfluence dispensingprotocols.

PATIENT EDUCATION

1. Offer hormonal ECby advanceprescription,especiallyifsheisatriskforinconsistentuse.

2. Provideback-upandintervalmethod,ifnecessary.

3. Advisepatientthathormonalcontraceptionissaferforherthanpregnancywouldbe.

4. Discuss Method Effectiveness (see QFP pg. 9, ref. #31).

5. Counsel patient that most women do not experience any significant side effects when they use hormonal contraception but that she may experience unscheduled spotting or bleeding or may have other changes in her menstrual periods with hormonal contraceptives. Skin pigment changesarealsopossiblewithestrogen-containingcontraceptives.Thepatientshouldbeadvisedthatthere isachancethatshemayexperience(atleasttransiently)someothersymptomsthatmayor maynot beduetohercontraceptives,includingnausea,vomiting,breasttenderness,headache,mood changes,nervousness,hairloss,acne,hirsutismorchangeinappetite.Itisveryuncommonto havesignificantchangesinweightorinsexdrivethatareattributabletohormonalcontraceptives.

6. Reinforcedangersignsforrareseriouscomplicationswithcombinationbirthcontrolmethods, usingtheso-calledACHESmnemonic.Advisepatienttoseekimmediatemedicalcareifanyof thefollowingoccurstoher:

A-Abdominalpain.

•Bloodclotinthepelvisorliver.

•Benignlivertumororgallbladder disease.

C-Chestpain.

•Bloodclotinlungs.

•Heartattack.

•Angina(heartpain).

•Breastlump.

H–Headache.

•Stroke.

•Migraineheadachewithneurologicalproblems(blurredvision,spots,zigzaglines, weakness,difficultyspeaking).

•Otherheadachescausedby pills.

•Highbloodpressure.

E-Eyeproblems.

•Stroke.

•Blurredvision,doublevision,orlossofvision.

•Migraineheadachewithneurologicalproblems(blurredvision,spots,zigzaglines).

•Bloodclotsinthe eyes

•Changeinshapeofcornea(contactsdon’tfit).

S-Severelegpain.

•Inflammationandbloodclotsofaveinintheleg.

7. Remindpatientthathormonalcontraceptivesdonotprotectagainstsexually transmitted infections,includingHIV/AIDS.

8. Advisepatientthattherearesignificanthealthbenefitswithhormonalcontraception,including lessmenstrualbleeding,lessmenstrualcrampingandreductionintheriskofovarianand endometrialcancer.Tellwomenwhoareconcernedaboutsideeffectsofhormonalcontraception thatlongtermstudieshaveshownthatwomenwhohaveusedbirthcontrolpillslivelongerand havelesscancerthanwomenwhoneverusepills.

9. Encouragehealthylifestyles,includingsafersexpractices.

10. IfOCsgiven,reinforceeducationwithparticularemphasison:

a.Initiationinstructionsforpills.ThepreferredmethodisQuickStart(samedayasvisit)orfirst daystart(firstdayofnextmenses).Sundaystartisacceptable.OCinitiationinstructions:

1) IfstartingOCsondays1-5ofcycle,noabstinenceorbackupmethodneededforthat cycle.

2) IfOCsstartedlaterthan5daysafterLMP,usebackupmethodfor7days.Ifhistoryof unprotectedintercoursewithinthelast5days,adviseECnow.(SeeEmergency Contraception(EC)protocol). HavepatientstartOCstonightortomorrowanduse7 days of abstinence or a back-up method for 7 days following her first pill. Recommend pregnancy test if scheduled bleeding is absent, late or abnormal.

b.Pill use. Advise patient to take OC’s at the same time of day each day and tell her what to do if she is late taking her pills.

1)The new rules about missed pills have been greatly simplified but may still be too complicated to tell patients to follow on their own.

a) Ifthewomanremembershermissedpillwithin12hoursofthetimeshewasto take it,sheshouldtakeitimmediatelyandtakeeachoftherestofherpillsattheusual time.

(1)Noback-upmethodisneeded.

(2)NoECisneeded.

b) Ifawomanmissesonepillformorethan12hours,shouldtaketoday’spillnowand useabstinenceoraback-upmethodforthenext7days.NoECisneeded.

c) Ifawomanmissesmorethanonepill,sheshouldtaketoday’spillandthelast forgottenpilltoday(2tabletsinoneday).Therestoftheinstructionsdependupon whichpillsshemissed.

(1)Ifshehasatleast7activepillsleftinherpack,sheshouldtakeonepilladay,

takeECifshehadanyunprotectedintercourseinthelast5daysanduse abstinenceoraback-upmethodforthenext7days

(2)Ifshehas7orfeweractivepillsinpack,shehas2options:

(a) Taketherestoftheactivepills,skiptheplacebosandstartthenextpackof pillswithoutinterruption.Useabstinenceoraback-upmethodforthenext7 days.UseECifshehashadintercoursewithoutusingotherprotectioninthe prior5days.

(b)Completethepackofpills,includingtheplacebopills.Useabstinenceora back-upmethoduntilshehastaken7ofthepillsinthenextpack.UseECif anyunprotectedintercourseinthelast5days.

2) Whilethesenewmissedpillrulesareverycomplete,theyarealsocomplicated.The odds arethatifpatientmissedapilllateinthepack,sheprobablymissedapillortookitlate sometimeearlierinthepillpack.Forthisreason,ithasbeensuggestedthatifapatient missesanyactivepill,sheshouldbeinstructedto:

a) TakethemissingpillASAP.Ifshemissedmorethanonepill,sheshouldalsotakethe pillfortoday.

b)Sheshoulduseabstinenceorcondomsforthenext7daysifsheneededtotakemore thanonepill.

c)FinallysheshoulduseECifshehadanyunprotectedintercourseintheprevious5 days.

c.Advise patient to consult the Patient Information from manufacturer’s package insert.

11.If vaginal rings are selected:

a.Iffirstringplacedinvaginaduringfirst5daysof menses,nobackupmethodisneeded.

InstructpatientwhoneededECtoreturnforrepeatUCGifno mensesin3-4weeksorif symptomsofpregnancydevelop.

b. Reinforceeducationaboutcorrectringplacement,timingandremoval.Teachuseoftampon insertertoplacering,ifneeded.

c.AdvisepatienttoconsultNuvaRingPatientInformationfrommanufacturer’spackage insert.

d. Suggestthatpatientstoreunusedringsinrefrigerator,becauseringshavelongershelf lifeif theyarerefrigerated. Cautionpatientnottostoreringsinfreezer.

e.Reinforceneedtouseringscontinuouslyfor3weeksatatime.Ringdoesnotneedtobe removedduringintercourseorduringanytreatmentsforvaginalinfection.

f.Advisepatienttostoreringinitsfoilpouchifshedoesremoveittemporarily.

g. Ifringremovedfromvaginaformorethan3 hoursduringany24hourperiod,recommend abstinenceoruseofaback-upmethodfornext7days.ConsiderECifintercourseoccurred withringoutofthevaginamorethan3hours.

h. Womenshouldnotdouchewhileusingvaginalring,butvaginalmedicationsmaybe used.

i.Forwomenwhowanttohavemonthlybleeding,instructthemtoremovetheirringafter21 days of use.Theirscheduledbleedingshouldstartaftertheringisremoved.Anewring

shouldbeplaced7daysaftertheoldoneisremoved,regardlessofwhetherherscheduled bleeding is over or not.

j.Forwomenwhodonotwanttohavemonthlybleeding,advisethemtoremovethecurrent ringafter28-31daysofuseandtoreplaceitimmediatelywithanewring.Thisextended cycleusemaybecontinuedforatleast12 months.

k. Tellpatienttoplaceusedvaginalringsintofoilpouchorothersealablebag.Disposeofused ringsinsolidtrash,notintoiletortrashcompactor.

12.Ifthepatientselectsatransdermalcombinationcontraceptivepatch:

a.Reinforcewithpatientthecorrectapplicationprocess,correctpatchlocationandtimingof placementandremoval.

b. Remindpatientaboutpatchinitiationinstructions.Quickstartispreferredmethod.Firstday startisacceptable.Womenswitchingfrompillsshouldplacefirstpatchonduringthefirstday ofscheduledbleeding.

c.AdvisepatienttoconsultOrtho-EvraPatientInformationfrommanufacturer’spackageinsert. Tellpatientthatproductlabelingsuggeststhattheriskofvenousthromboembolismmaybe higherwiththepatchthanwithpilluse,butthattheriskofbloodclotswiththepatchisless thattheriskofbloodclotsifshegetspregnant.

d. Adviseaboutpossibleskinirritation.Tellhertostoppatchuseifshedevelopsirritationand returnpromptlytogetanothermethod.

e.Educatepatientaboutrecommendationsformanagementofpatchdetachment.

1)Ifpatchdetachesforlessthan24hours:

a) Reattach.Donotuseothertapesorbandages.

b) Ifunabletoreattach,discardthatpatch.Applynewpatch.Changethatnewpatchon usualday(samedaythatshewouldhavechangedoldpatch).

c) Noneedforbackup method.

2) Ifpatchdetachesfor24hoursor moreorifsheisnotsurehowlongpatchwasdetached, havepatientplacenewpatchanduseabstinenceoraback-upmethodfor7days. RecommendECifunprotectedintercourseduringlast5daysorduringfirst2daysof patchreplacement.

f.Advisepatientaboutwhattodoifshedoesnotchangeherpatchafter7days.

Recommendationsdependupontheweekofpatch use:

1) Iffirstpatchofcycle-applynewpatchanduseback-upmethodfor7days.

2) ifsecondorthirdpatchofcycleand:

a) Latelessthan48hours–applynewpatch.

b) Late48hoursor more–applynewpatchanduseback-upmethodfor7days.

g. Remindpatientstoavoidusinganycreamsorlotionsontheskinaroundthepatch,sincethis willcausepatchdetachment.

h. Ifthepatientnotesagreylintringonherskinafterremovalofthepatch,recommendshe applyhandorbodylotionorevencookingoiltoremoveit.

i.Tellpatienttofoldherusedpatchinhalfwithadhesivesidestogetherandplaceitinroutine trash.Donotflushthepatchdowntoiletorplaceitintrashcompactor.

REFER TO MD/ER

Anypatientwhodeclinespelvicexaminationbuthassymptomsorsignsindicatingneedfor evaluation.

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