New Contraceptive Options in Primary Care

Kelly Kruse Nelles MS, RN-C, NPClinical Associate Professor

UW School of NursingUW Women’s Health Center

Learning Objectives:

1. Recognize the role of family planning as an important part of primary health care.

2. Identify 3 new methods of contra-ception and the correct use for each.

3. Select candidates that may benefit from new contraceptive methods.

Statement of Financial Disclosure:

This talk has not been sponsored by any organization.

Why Family Planning in Primary Care? A typical woman in the U.S. spends about

36 years – almost half of her lifespan at potential biological risk of pregnancy.

Nearly half of pregnancies in the US are still unintended – 3.2 million

Among industrialized countries, the US still has the highest rate of teenage pregnancies, unintended pregnancies, and abortions

Of women aged 15-44, 49% will experience unintended pregnancy

Impacts Preconception care Maternal and child morbidity Maternal and child mortality Resulting consequences for the

family and society

Dissatisfaction with Contraceptive Methods Plays a large role in unintended

pregnancy As many as 60% of women starting OCs

stop within the first 6 months resulting in >1 million unintended pregnancies

Most stop current contraception due to side effects

20% of women selecting sterilization at age 30 years or younger later express regret

Contraceptive Properties Desired by Women Highly effective Prolonged duration of action Rapidly reversible Privacy of use Protection against STI Easily accessible

Perfect vs Typical Use Typical Use – pregnancy rates during

typical use reflect how effective methods are for the average person who does not always use methods correctly or consistently.

Perfect Use – predicts the probability of method failure (pregnancy) during the first year of use when a method is used perfectly and consistently

Typical use reflects the user while perfect use reflects the method

Current Trends in Contraception Development of new delivery

systems Increased access to a full range of

options Emphasis on greater success Decreased side effects Wider use of emergency

contraception

Recognition of Health Benefits of Hormonal Contraception Menses related benefits

Cycle regulation Decreased blood loss with resulting

decreased iron deficiency anemia Improved dysmenorrhea

Benefits of inhibiting ovulation Decreased incidence of ovarian cysts Decreased incidence of ectopic

pregnancy

Other health benefits Decreased benign breast disease and

fibroadenomas Decreased incidence of acute PID Protection against Endometrial and Ovarian

cancers Maintains bone mass Possible decreased risk of Colorectal cancer Often improves Rheumatoid Arthritis

Candidate Selection for Hormonal Contraception

Art vs Science Helpful to assess the woman’s

body type when selecting hormonal contraceptive options

Determine if she can safely use estrogen

Determining if Estrogen Can Safely Used

Ask yourself: Is this person a good candidate for a

method with estrogen?

Absolute Contraindications to Estrogen Use Thrombophlebitis or thromboembolic disorder Family history of hereditary thrombophilia in a first

degree relative Cerebrovascular disease Coronary artery or ischemic heart disease Known or suspected breast cancer Known or suspected estrogen-dependent neoplasia Known or suspected pregnancy Benign or malignant liver tumor Current impaired liver function Undiagnosed vaginal bleeding

Relative Contraindications (exercise caution): Vascular or migraine headaches, especially if

they began or worsened with the use of combined hormones

Hypertension Acute mononucleosis or recent hepatitis Presence of factors predisposing to

thromboembolic disorder: illness or surgery requiring immobilization, long leg cast, trauma to lower leg

Relative Contraindications (exercise caution): Cardiac or renal dysfunction (or hx of) Diabetes mellitus Obesity (>20% ideal weight) Lactation Age over 50 Age over 35 for a smoker Psychic depression History of MI in an immediate family member

before age 50 – especially a mother or sister

Relative Contraindications (exercise caution): Hyperlipidemia Active gallbladder disease Sickle cell or Sickle cell C Disease Completion of a term pregnancy in the past

10-14 days Ulcerative colitis Asthma

If Yes, base your selection on: Body type – estrogenic vs androgenic Monophasic vs triphasic method Number of micrograms of ethinyl estradiol Availability of the method Ability to understand and use the method

correctly Cost Prior experience with other methods

Acronym of Contraceptive Counseling

BRAIDED: Benefits of the method Risks of the method Alternatives to the method Inquiries about the method are the patients right and

responsibility Decision to withdraw from the method without

penalty Explanation of the method that is understandable Documentation that the hcp has ensured

understanding of each of the proceeding points

Hormonal Side Effects

Estrogen Sensitivity Progesterone Sensitivity

The Contraceptive Patch Ortho Evra transdermal system Combination hormonal method

releasing 20 mcg ethinyl estradiol/150 mcg norelgestromin daily

20 cm square applied to abdomen, buttocks, upper outer arm or upper torso – not breast.

Use is based on a 28 day cycle On the first day of each of the first

three weeks, a new patch is applied and worn 7 days, then discarded

During the 4th week, no patch is worn and withdrawal bleeding occurs

Ideally, first patch should be applied on the first day of menses and is considered immediately protected

If patch is applied at any other time in the cycle, a back up method should be used for 7 days

The patch should be applied on the same day of each week (patch change day)

Apply to clean, dry, healthy skin free of creams or lotions

May bathe, shower, swim, exercise while wearing

Partial or complete detachment has been shown to occur in <5% of cases

If it does fall off, immediately apply a new patch and then replace it on her regular patch change day

When prescribing the patch, write for a single replacement patch as well.

If the patch is off for longer than 24 hours, a new cycle must be initiated with a new patch, and back up for the next 7 days.

Effectiveness: An analysis of pooled data from

studies involving >3,300 women showed that the overall probability of pregnancy in patch users was 0.8%

Comparable to OCs

Ideal for women who find it difficult to remember to take a pill at the same time daily

Among patch users, the mean proportion of cycles with perfect compliance is 88.2% as compared with 77.7% among OC users

97-98% women stay with the patch Easy and convenient

Break through bleeding less with the patch vs the pill

If worn on buttocks, BTB is even less as absorption is better

Adverse effects similar to OCs although breast tenderness is more prevalent (19% patch vs 6% pill) Resolves after 1-2 months

Application site reactions (1-2.4%) Women weighing 198 lbs or > may

experience a higher failure rate Inform that risk of pregnancy is higher Counsel on use of combined methods

No significant impact on LDL/HDL ratios Drug interactions reported with OCs are

assumed to pertain to patch Contraceptive effectiveness may be reduced

when coadministered with some antibiotics, anitfungals, anticonvulsants, and other drugs that increase metabolism of contraceptive steroids

Barbiturates, griseofulvin, rifampin, phenylbutazone, phenytion, carbamazepine, felbamate, oxcarbazepine, topiramate, and possibly ampicillin

Contraindications similar to OCs Valvular heart disease with complications Severe hypertension Diabetes with vascular involvement Headaches with focal neurological

symptoms Acute or chronic hepatocellular disease with

abnormal liver function Hypersensitivity to any component of the

product

The Vaginal Ring The NuvaRing is a flexible transparent

device made of ethylene vinyl that is inserted into the vagina

It is a combination contraceptive releasing 15 mcg ethinyl estradiol/120 mcg etonogestrel daily over 3 weeks of use

It is removed for week 4 during which time withdrawal bleeding occurs

A new ring is then inserted

Requires lower hormone doses than OCs as administration vaginally precludes hepatic or GI interference

Effectiveness similar to combined OCs, the ring offers more uniform plasma hormone concentrations

Women report: Easy to use Does not require fitting Convenient – needs to be

administered only once each month Can be left in place during swimming,

bathing and intercourse

Combined data from 1,950 North American and European women who use the ring for at least 3 months:

96% of those who completed 13 cycles of use were satisfied or very satisfied

85% of women and 71% of their sexual partners said they never or rarely felt the ring during intercourse

85% of women reported menses of the same or shorter durations

85% reported menstrual pain as unchanged or reduced

Of 821 women (35%) who did not complete the study: 52% gave reasons not related to the

device (ex: wishing to become pregnant)

43% referred to adverse effects (ex: tendency for the ring to fall out)

2.6% said they were pregnant 2.3% complained of irregular bleeding

Ring specific adverse effects include vaginal irritation, infections and discharge

Vaginal medications (such as antifungal creams) can be used while the ring is in place

Mirena Intrauterine System Like the copper T IUD, Mirena is

inserted by the clinician into the uterine cavity to prevent pregnancy

Also T shaped it is the size of a quarter and made of a soft flexible plastic containing 52 mg of levonorgestrel in a release controlling membrane with a monofilament string

Levonorgestrel is released at 20mcg/day Thickens cervical mucus Suppresses ovarian function Inhibits sperm movement Thins uterine lining making it an

unfavorable environment for implantation

Approved for 5 years of continuous use Is appropriate for women in whom

estrogen is contraindicated Can be an effective treatment for

women with dysmenorrhea, menorrhagia, and anemia

Low maintenance – only need to check strings after each menstrual period to ensure device is in place

For women who choose to become pregnant Device can be removed at any time No waiting period is required before

conception Mirena is not associated with decline

in fertility

Women need to be counseled that complete or temporary amenorrhea is likely to occur within 1 year of use (20-56%)

Bleeding irregularities rarely contributed to discontinuation of use

Combined Oral Contraceptives Popular method since introduction

in the 1960s Initial doses contained as much as

150 mcg of estrogen thus posing significant health threats (DVT, PE, CVA, MI)

Today 98% of all pills contain less than 35mcg of estrogen

Ethinyl Estradiol 20, 25, 30, 35 mcg (low dose) 50mcg (high dose)

Pills with low estrogen are considered safer for certain patients Perimenopausal women Those with a family history of heart disease Smokers younger than 35 (although risk of

MI and stroke due to OC-associated changes in coagulation factors remain)

Progestins have changed as well Today’s combined OCs contain

about 10% of amount found in OCs manufactured in the 1970s

Decreased progesterone related side effects: nausea, breast tenderness, bloating

Progestins Norethindrone Levonorgestrel Norgestrel Desogestrel Drospierone

Yasmin FDA approved in 2000 Contains drospirone (DRSP) with

antiandrogenic and anitmineralocorticosteriod properties

Associated with less water retention, less negative emotional affect, less appetite increase after 6 months of use

Women who took this pill did not experience statistically significant changes in weight or BP after 13 months of use

DRSP contains spironolactone and may benefit women with androgenic presentation (acne, hirsutism, obesity)

Should not be used by women with: History of hyperkalemia secondary to

renal insufficiency Hepatic dysfunction Adrenal insufficiency

Consider prescribing a different type of OC for women who take medications that affect serum potassium levels

Monitor potassium levels in the first cycle with these drugs Angiotensin-converting enzyme inhibitors Angiotensi II receptor antagonists Other potassium-sparing diruetics, heparin,

aldosterone antagonists, NSAIDs

25mcg Pills Triphasic with desogestrel (Cyclessa) Triphasic with norgestimate (Ortho

Tri-cyclen Lo) Monophasic with norgestimate (Ortho

Cyclen Lo)

Estrostep Only pill that steps estrogen instead

of progestin 20/30/35 mcg EE Helpful option for women

experiencing estrogen related pill side effects

New pill taking patterns to shorten or eliminate pill-free period First day start every cycle

Need to prescribe extra cycles Continuous use

Bicycling – 2 months continuous use = 6 periods/year

Tricycling – 3 months continuous use = 4 periods/year

Monophasic pill recommended

Seasonale Approved September 2003 30mcg EE and .15mg levonorgestrel Taken 84 days consecutively, followed by 7

days of placebo pills Tested in randomized clinical trials of 1,400

women ages 18-40, comparing it to traditional OCs.

Effectiveness and Safety profile very similar to traditional pill

Advantages to continuous cycling Option for women with

dysmenorrhea, PMS Convenient (military, travel, sports,

upcoming events) Decreased iron deficiency anemia

from menorrhagia Helpful for women with cognitive

impairment or physical disability

Concerns Presentation of menstrual suppression

as the more natural or healthier option (no studies to support)

May cause women who prefer a monthly cycle to worry about the health effects of their decision not to control their periods

May send a negative message to young girls about menstruation and their bodies

Drug-Drug Concerns Related to OCs Amoxicillin and tetracycline – circulation

levels still within normal range Rifampin, antinconvulsants, St. John’s

Wort, phenylbutazone decrease circulating hormone levels

Drugs causing increased uptake of hormones include atrovastatin, ascorbic acid, acetaminophen, cyclosporine, prednisolone, theophylline

OCs decrease levels of anticonvulsants, temazepam, ASA, morphine, clofibric acid

Carefully choose formulations for women with Lactose intolerance IBS with diarrhea Bulemia

Other Progestin Only Methods Mini-pill (Micronor)

Taken continuously May or may not get a withdrawal bleed Timing is important in maintaining efficacy Very helpful pill for post-partum women and women

who cannot tolerate estrogen Depo Provera

Injectable contraceptive that prevents pregnancy for 3 months at a time.

Also, a great alternative for women who cannot tolerate estrogen, who are breastfeeding, or have a history of seizure disorder

Emergency Contraception Plan B

Levonorgesterol only 0.75mg as soon as possible within 72 hours

or risked pregnancy and second dose 12 hours later

Preferred formulation – higher efficacy and fewer side effects

Side effects: nausea 20%, vomiting 6%, headache 15%, menstrual changes depend on when in cycle EC is used

Preven Combination 100mcg EE + 0.5 mg LNG as

soon as possible within 72 hours of risked pregnancy and second dose 12 hours later

40% women experience severe nausea and vomiting

Recommended that OTC antiemetics (Meclizine 25 mg, Dramamine II or Bonine 2 tablets PO) be offered 1 hour prior to first dose to halve GI complaints

Note: 30% women report drowsiness with use of antiemetics

Efficacy improved if taken early Failure rate if taken in first 12 hours: 0.5% Failure rate if taken after 60-72 hours: 4% Residual benefit with higher failure rate after

72-96 hours ACOG initiative: offer advance EC

prescription to all reproductive aged women at routine visits Better utilization if patient has EC in

possession

Future Methods Non-incisional Sterilization

Techniques Essure

Transcervical insertion of a spring-like mechanism into the opening of the fallopian tubes

Over several weeks scar tissue grows around the spring to occlude the tube

Office procedure Highly effective, well tolerated

For more information contact:Jim Robinson, MDOB-GYN Residents ClinicUW Women’s Health Center451 Junction RoadMadison(608) 263-0150www.Essure.com

Lunelle (hoping for a come back) Once a month combination

contraceptive injection Efficacy and contraindications same as

OCs Administered IM every 28 days +/- 5

days Recalled not because of the product

but rather the delivery system

Implants Implanon

Progestin only implant (etonogestrel) that is good for 1 year

Efficacy: 0 pregnancies for 13 trials with 70,000 cycles

Mechanism of action: Works by suppressing ovulation over time and thickening cervical mucus

Return to fertility: ENG levels not detectable 1 week after removal. 94% of women ovulated within 3 weeks after removal.

Side effects: changes in vaginal bleeding – similar to all progestin-only methods

Norplant II (Jadelle) Similar to previous Norplant only for 2 years

instead of 5 Improved insertion and removal

New Female Barriers Femcap Lea’s Shield Disposable diaphragms

Improved spermicidal/virucidal agents Today Sponge

New fertility monitors to improve success of natural family planning

New delivery systems for sex steriods (eg, bracelets)

GnRH agonists with estrogen/progestin add-back

Male hormonal methods Progestin and Testosterone (MENT)

Other compounds for Emergency Contraception Mifepristone 10mg Other levonorgestrel pills

Vaccines

In Summary:

Not only is every recommended method of birth control safer than pregnancy, but recent studies (Trussell) have now clearly shown that every method of birth control is more cost effective than pregnancy

Kelly Kruse Nelles MS, RN-C, WHNPUW School of NursingUW Women’s Health Center 451 Junction RoadMadison, WI 53715(608) 263-0150 (WHC)(608) 263-5337 (SON)kl.krusenelles@hosp.wisc.edu