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Home , Estrogen patch, Norelgestromin, Yuzpe regimen

Contraception

Xandie Gold, MD Objectives

• Review Different Methods of Contraception • Review the advantages and disadvantages of each method • Choose appropriate contraception based on different clinical situations • Review how to prescribe contraceptives

Unintended

• 49% of pregnancies in US are unintended • Rates: 82% in teenagers and 38% in perimenopausal women • Half of unintended pregnancies end in terminations

Contraceptives

• Hormonal Contraceptives: – oral, , intravaginal, IM, implanted • Barrier Devices – Diaphragm – : male and female – Cervical Caps

Contraceptives • Surgical: – ,

• Intrauterine Devices: – IUDs: copper or releasing

Oral Contraceptives

• Introduced in early 1960s • Most widely used form of reversible • Have contraceptive and noncontraceptive benefits • + progestin combination or progestin alone

Combination Pills

• Synthetic – Ethinyl – • Synthetic progestins – Many different progestins available

Estrogen Component

• Ethinyl estradiol doses range from 20 -150 mcg – Doses > 50mcg no longer available in US – Low dose estrogen (35 mcg or less) recommended as initial treatment • Higher doses increase incidence of VTE • Lower doses may result in significant breakthrough bleeding or spotting • 20 mcg dose helpful in premenopausal women or those with significant estrogen side effects – 50mcg dose needed in women on certain anticonvulsants – Ex: Genora 1/50; Nelova 1/50, Ortho-Novum 1/50, Demulen 1/50

Progesterone Component

• Progestin doses range from 0.05mg – 1mg • Differ in their androgenic, estrogenic, and progestational activity

First Generation Progestins

• Norethindrone – ex: ortho-novum, necon • Norethindrone acetate – ex: junel, estrostep, loestrin • Ethynodiol diacetate – ex: zovia • Medium androgenic potency

2nd Generation Progestins

• High progestational and androgenic activity • • Most widely prescribed progestin – Ex: Levlen, Alesse, Tri-Leven, Triphasil • Approved for • Approved for extended cycle use –ex: seasonal • – Ex: cryselle, lo-ovral 3rd Generation Progestins

• ( ortho-cyclen or tri- cyclen) • FDA approved to treat • (desogen, ortho-cept) • – not available in US

3rd Generation Progestins

• Lower androgenic activity • Less acne, hirsutism, weight gain • Less effect on carbohydrate and lipid profile • Similar contraceptive effectiveness as older formulations • Higher rates of DVT

4th Generation Progestin

• Drosperinone – new progestin derived from 17-alpha – Progestogenic, antiandrogenic, and antimineralcorticoid activity – Ex: Yasmin: 30 mcg of ethinyl estradiol and 3 mg of – Yaz: – Useful in women with excess water retention, acne, hirsutism – Watch for hyperkalemia

Variety of Combination Pills:

• Monophasic • Multiphasic - 2 or 3 different progestin doses • 21 day regimen • 28 day regimen – 21 active pills + 7 inert pills – 24 active pills + 4 inert pills • Ex: YAZ and Lo-estrin Continuous OCP

• Extended cycle – Seasonale – 91 days total – 84 days active + 7 days inactive – Seasonique – 91 days total - 84 days active + 7 days 5mcg ethinyl.estradiol • Useful for , premenstrual dysphoric disorder, or lifestyle reasons • Efficacy unchanged • Breakthrough bleeding common • No risk of endometrial hyperplasia

Effectiveness

• If taken correctly: 99.9% • In reality: 92.4% • Return to fertility: – Average 2 month delay in conception after OCP’s stopped

Mechanism

• Suppress ovulation • Suppress follicular development • Alter cervical mucous making sperm penetration more difficult • Alters making implantation less likely

Noncontraceptive Benefits

• Definite • Decreases DUB by 81-87% and menstruation related anemia • Decreases • Decreased risk of ovarian cancer • Decreased risk of by 50% • Decreased risk of PID (50-80%) • Decreased risk of ectopic • Treatment of Acne Noncontraceptive Benefits

Possible: • Reduced risk of Colorectal Cancer • Reduction of Uterine Leiomyomas • Decrease in benign disease • Reduces Ovarian Cyst formation • clear benefit at 50mcg estrogen dose • Decreased fracture risk

Risks of Combination OCP

• DVT: risk 3-6 fold – Absolute risk is 3-4 per 10,000 – Risk increased in third generation progestins: • Compared to nonusers, risk of DVT increased 6-9 fold – Presence of hypercoagulable state increases risk even further

Risks Continued

• – Ischemic: increased risk by 2 ½ times • Increased risk with age, HTN, • : – 80% of cases of MI among OC users are in smokers – OC are contraindicated if age>=35 and smoke >15 cig/day • HTN

Risks Continued

• Hepatic vein thrombosis • Portal vein thrombosis • Splenic artery thrombosis • Mesenteric artery thrombosis • Mesenteric vein thrombosis

Risks Continued

• – results conflicting – large meta-analysis 1996: • Slightly increased risk of breast cancer during use and for first ten years after use – RR 1.24 • No increased risk of diagnosis after 10 years off OCP • Cancers usually less clinically advanced if diagnosed while on OCP or up to 20 years after OCP use – Epidemiologic studies have generally not demonstrated an association between OC use and the risk of breast cancer later in life

Contraindications

• Pregnant or breastfeeding • History of DVT, PE, MI, Stroke, Hypercoagulable state • disease • Smoker >15 cig/day age> 35 • Complicated Migraine Headaches or in women > age 35 • Estrogen dependent tumor –breast, endometrium • Uncontrolled HTN, unexplained

Choosing OCP’s

• No benefit of triphasics over monophasics • Estrogen content 35 mcg or less • Consider OCP w/ lower androgenic properties but weigh against increased risk of DVT • Common starting regimens: – 2nd gen: Levlen, Alesse, lo-ovral – 3rd gen: Ortho – cyclen, desogen • Higher estrogen doses needed initially in women with heavy flow and cramps – Ex: ovral (50 mcg), ogestrel Choosing OCP’s

• Become familiar with 1 or 2 brands with varying estrogen and progesterone levels in case need to adjust based upon profile Starting OCP’s • Sunday start – First Sunday of LMP – Use a backup method for 7 days for first month • Quick start – Start first pill at time of office visit – Increases compliance – Back up method for 7 days Monitoring on OCP’s

• No lab studies mandatory at starting or for monitoring • Can be started prior to breast or pelvic exam • BP check at f/u Missed Pill

– Miss one pill anytime in cycle • Take missed pill immediately and next pill at regular time – Miss two pills on First or Second Week of Pack • Take two pills daily for next two days then resume schedule – (Monday and Tuesday) remembers Wednesday – On Wednesday take Monday and Tuesdays pills – On Thursday take Wednesday and Thursday’s pills • Use backup for 7 days

Missed Pill

– Miss two in third week • Take two pills daily until all active pills completed • Restart cycle with one pill daily within 7 days • Use backup method until new pack restarted and for first 7 days of new pack – Miss 3 more during any week » Throw the pack away and start a new pack within 7 days » Use backup method of birth control for first 7 days of new pack

Combination Contraceptives

• Side effects: – Breakthrough bleeding – most common reason for discontinuation – – Weight gain – swings – Breast tenderness – Headaches – Acne, facial hair growth Breakthrough Bleeding

• Most common in low dose combination pills • Most frequent in the first three months as endometrium adjusts to lower levels • Increased rate if miss a pill • Increased rates in extended use cycles

Breakthrough Bleeding

• Treatment options – Increase estrogen dose • Bleeding early in cycle or no withdrawal bleeding • Ex: ortho tri cyclen lo (25 mcg) to orth-tri cyclen ( 35 mcg) – Increase progestin dose • Bleeding after day 14 in cycle – Change to more androgenic progestin • Decreases bleeding at any time during cycle • Ex: levlen ( LNG progesterone) – Switch from extended cycle to 28 day cycle regimen Nausea

• Related to estrogen dose • Usually most severe in first 1 – 3 cycles of OC use • Management: – Take with food or bedtime – Change to OC with lower estrogen dose Headaches

• Related to high estrogen content • Usually concentrated in pill-free days and first days of cycle • Ischemic stroke risk increased in patients with hx of migraines – Do not give to women with aura or focal symptoms – Do not give to women with migraine over age 35 – Do not give if frequent or severe migraine hx

Migraines and Stroke Risk

• Meta-analysis - relative risk of ischemic stroke among women with migraine taking oral contraceptives, from the pooled data of three studies, was 8.72 (95% CI 5.05-15.05)

Risk of ischaemic stroke in people with migraine: systematic review and meta-analysis of observational studies. AUEtminan M; Takkouche B; Isorna FC; Samii A SOBMJ 2005 Jan 8;330(7482):63. Epub 2004. Headaches Continued

• Treatment: – d/c in women with new migraine headaches or worsening of pre-existing headaches – Switch to OC with lower estrogenic activity – Switch to progestin only contraceptive – Try extended cycle OCP to decrease pill free intervals Libido Changes

• Decreased: – Direct action on brain from progestin – Increase in -binding induced by estrogen • Treatment: – OCP with less estrogenic or progestational properties – Higher androgenic properties • Progesteron component: levonorgestrel,dl-norgestrel, desogestrel • Ex: alesse, lo-ovral, levlen Thyroid

• The estrogen component of OC pills raises serum concentrations of thyroxine-binding globulin (TBG) – Increased levels of total thyroxine & total triiodothyronine – No change in levels of free thyroxine and free triiodothyronine – T3 resin uptake will be low Liver

• Hepatic adenoma • Correlates with dose and duration of OCP use • Incidence 30-40 / 1 million in OCP users – 1 / 1 million women in non users • Increased number, size, and risk of bleeding in OCP users • s/s: , incidental, rupture / abd bleeding Progesterone Only Pill

• Micronor / Nor-QD / Camila / Erin / Jolivette / Nora-B / Ovrette - • 0.35 mg norethindrone • Lower than doses in combination pills • Marketed in US • 28 days of active pills • Success rates: typical failure rate thought to be > 8%

Progesterone Only Pills

• Mechanism of action – Thickens cervical mucous, thins endometrium, inconsistent ovulation suppression • Start first pill on first day of LMP • Pills MUST be taken at the same time every day to ensure effectiveness – Missed pill defined as taken more than 3 hours later than usual – If taken later women should take immediately + next pill on time + added precautions x 2 days Progesterone Only Pills

• Side effects: – Irregular bleeding – Ovarian cysts – Breast tenderness • Clinical uses – Breastfeeding – Contraindication to estrogen containing pills – Estrogen related side effects on combination pill – Heavy smokers over age 35

Depo-Provera

• IM of 150 mg every 12 weeks • 99.7% success rate • : – Thickens cervical mucous-less penetrable to sperm – Suppresses ovulation

Depo-Provera

• First dose given within 5 days of LMP • If given >=7th day of LMP, another form of contraceptive should be used for 7 days • Efficacy is up to 14 weeks

Clinical Uses

• Can’t or won’t take daily OC • Migraine headaches • Breast feeding – Can start after 6 weeks • Efficacy: 99.7% ( theoretical and actual)

Depo-side effects

• Irregular bleeding – Persistent bleeding can be treated with 50 mcg of ethinly estradiol for 14 days • Other: weight gain, headaches, dizzy, injection site reactions • Takes about 6-9 months after last injection for return of fertility but may be as long as 18 months in Depoprovera

• Accelerated rate of bone loss – Increases with increasing duration – No data on fracture risk – Majority will be reversible within 1-2 years of discontinuation – Black box warning by FDA in 2006 limits use to 2 years except in those patients in which other forms of birth control methods are inadequate • September 8th 2008 ACOG opinion statement disagrees – Not recommended to have routine BMD – Ensure adequate exercise, vitamin D, and intake Contraindications to Progestin only regimens

• * Hx of or current thromboembolic disorders or Cerebral vascular disease • Severe hepatic dysfunction or disease • Carcinoma of the breast or genital organs • Undiagnosed vaginal bleeding • Pregnancy

Implantable Progestins

• Nexplanon/Implanon () – progesterone releasing approved for 3 years – Single plastic rod about length of toothpick – Implant day 1-5 of cycle – Pregnancy rates similar to IUD and • Norplant – No longer available due to limited supplies and problems with removal

Estrogen Patch

• Ortho Evra: – Releases 20 mcg ethinyl estradiol and 150 mcg of per day • Each patch worn for 1 week for cycle of 3 weeks then withdrawal bleed during week 4 • Caution for women with weights over 90kg as may be less clinically effective Estrogen Patch

• DVT risk: – Steady state levels of estrogen much higher with patch users then OCP users – One study showed 2.4 OR increased risk of VTE for patch users compared to OCP users

Side Effects

• Breast tenderness • • Application site irritation • Nausea • Breakthrough bleeding Efficacy

• < 1 pregnancy / 100 users • Higher compliance rates than OCP users and higher “perfect use” rates Contracetive : Nuvaring

• Delivers 15 mcg of ethinly estradiol and 120 mcg of etonogestrel per day • Intravaginal for three weeks • Insert on or before day 5 of LMP-use backup for 7 days Side Effects NuvaRing

• Vaginitis • Leukorrhea • Weight gain • Nausea • Headache • Breakthrough bleeding Efficacy

• Similar to OCP use • Slightly higher rates of discontinuation due to local side effects Emergency Contraception

• Administer within 72 or 120 hours of unprotected intercourse – most effective if taken within 12 hours • Mechanism of action – Inhibits ovulation, prevents implantation, or may cause regression of corpus luteum Regimens

• : – 100mcg of ethinyl estradiol and 0.5 mg of levonorgestrel. E.g. Ovral, Preven (50mcg/0.25mg) • Take 2 pills within 72 hours and 2 pills 12 hours later – Has a 75-80% efficacy rate – Usually requires antimetic

Regimens

• Levonorgestrel: Progesterone only, Plan B/NextChoice – 1.5 mg once – Prevents 85% – Less nausea and – Available over the counter for women above age 17, with rx for under age 17 Regimens

• ella () – Selective modulator – Single dose of 30mg – Requires rx

• Paragard – Effective if inserted up to 120 hours after Barrier Methods

• Male ; efficacy 14/100 • Diaphragm: 20/100 • : – Never pregnant: 20/100 – Ever Pregnant: 40/100 • Today Sponge: barrier plus . Effective for 24 hours. Estimated efficacy of 89-91% – No special fitting required IUD Options

• Levonorgestrel (Lng IUC) – Mirena = trademark – Progesterone secreting – Can be left in place for 5 years – First yr pregnancy rate 0.1-0.2% – Irregular bleeding common early followed by development of in 20% IUD Options

• Copper T (Tcu380A IUD) – Paragard = trademark – Copper releasing – Approved to remain in place for 10 years – First yr pregnancy rate 0.6-0.8% – Heavy menses and dysmenorrhea common IUD Advantages

• Highly effective • Convenient • High patient satisfaction • Inexpensive over time • No effect on fertility after removal • Decreases risk of ectopic pregnancy compared to no contraception • LNg IUD can decrease risk of PID from newly acquired STD’s once IUD in place • Progestin thickens cervical mucous which acts as barrier to ascending infection

IUD Concerns

• High initial cost • No protection against STD’s • Small increase risk of PID in first 20 days after placement – Related to contamination during insertion process and presence of pre-existent STD’s • If pregnancy occurs while IUD in place then more likely to be ectopic CI to IUD Placement

• Pregnancy or suspicion of pregnancy • Congenital or acquired uterine anomaly • Active pelvic infection or high risk of pelvic infection • Known or suspected uterine or cervical neoplasia, or unresolved abnormal Pap smear • Unexplained abnormal uterine bleeding • Increased susceptibility to infections with microorganisms • Genital actinomycosis • Known or suspected carcinoma of the breast - progestin based IUD’s • Wilson’s disease or copper allergy - copper based IUD’s

Other Methods

• Lactation: – Most useful in first three months – Effective if woman is breast feeding full time and is amenorrheic • Tubal Ligation • Vasectomy Summary

• Many different methods – Pills (combined and progesterone-only), patch, ring, injection, implant, IUD, tubal ligation

• The best contraceptive is the one the patient uses! THANK YOU!

Contact: [email protected], [email protected]