Hatcher RA. Managing Contraception. Tiger, GA: Bridging the Gap Communications; 2012: Figure 23.1.)
Several studies have focused on the effect of COCs on serum lipoprotein
concentrations because of the association between lipoproteins and atherosclerotic
13–15 High levels of total cholesterol (TC), triglycerides (TG),
low-density lipoprotein (LDL) cholesterol, and very low density lipoprotein (VLDL)
cholesterol serum concentrations are associated with the risk of developing
atherosclerotic circulatory diseases, whereas high-density lipoprotein (HDL)
cholesterol has an inverse relationship. Apolipoprotein levels also affect
atherosclerotic risk (e.g., elevations in apolipoprotein increase risk).
Patients taking COCs may be more likely to experience a myocardial infarction
16 The risk is higher with higher doses of estrogen and especially
if the patient is a smoker or has hypertension. It is not clear whether certain types of
progestin are more likely to cause MI than others.
10,17 Combined oral contraceptive
users may also be at a slightly higher risk of stroke, but some data are conflicting.
Those at highest risk of stroke are smokers, patients with hypertension, and patients
S.F. and her fiance should understand that the risk of adverse cardiovascular
effects may be increased with CHC use, but the absolute risk is still very low no
matter which product is used. S.F.’s cigarette smoking, however, is a much more
significant risk factor for MI in combination with a CHC product.
Ischemic stroke is more likely to occur in CHC users with a history of migraines and
is thought to be caused by the estrogen component. The risk is further elevated in
women who have migraines with aura or among those who smoke.
experiencing migraines without aura should use CHCs with caution or avoid use if
they smoke and are at least 35 years of age.
7,19 Clinical experience indicates that
women who have increasing migraine attacks with CHCs are not likely to improve
when the product is changed to one with a different hormone balance. Headaches or
migraines may start with initiation of CHCs (see Case 47-2, Question 6); however, if
a patient experiences a migraine with aura while taking CHCs, she should
discontinue the product and switch to a nonestrogen method.
show an increased stroke risk with progestin-only contraceptives, and these agents
may be used in women with risk factors for stroke.
S.F. does have a history of occasional headaches but does not have a history of
migraines with aura. Therefore, she is still a candidate for CHCs but should be
informed of the increased risk of stroke from cigarette smoking.
Combined hormonal contraceptives contribute to thromboembolic events by several
mechanisms. Estrogens increase coagulability and thereby increase the possibility of
clot formation. Although they have been shown to significantly increase some clotting
factors, other studies have shown no changes or decreases in prothrombotic
13,15 Long-term COC use is associated with an increased platelet count and
increased platelet aggregation similar to that seen late in pregnancy; this is generally
thought to be caused by the estrogen component. More recent data showing increased
thrombosis rates in users of third-generation progestins (desogestrel and gestodene
[not available in the United States]) suggest that progestin may also have a role in
The baseline risk of venous thromboembolism (VTE) in women is low, at 1
case/10,000 person-years, but increases from 3 to 4 cases with COC use.
studies looking at thromboembolism in COC users found that most users have a
twofold-to-sixfold increased risk of having superficial or deep venous thrombosis or
20 Patients requiring emergency major surgery while taking
COCs are more prone to VTE than nonusers. The risk of venous thrombosis does not
seem to be associated with duration of COC use or past COC use. A greater risk is
associated with ethinyl estradiol (EE) doses greater than 35 mcg.
Women with a mutation in clotting factor V (also called factor V Leiden) or a
deficiency in protein C, protein S, or antithrombin are more likely to experience a
VTE with COCs than women without a hereditary prothrombotic defect.
with factor V Leiden using COCs have a 30-fold increase in VTE compared with
The minimal risk of thrombosis associated with CHCs in the general population
does not justify the cost of routine screening for deficiencies and mutations in the
coagulation system; however, if a patient has a family history of thrombosis, then
measurement of antithrombin III, protein C, activated protein C resistance ratio,
protein S, anticardiolipin antibodies, prothrombin G mutation, factor V Leiden, and
homocysteine levels should be considered.
Whether third-generation progestins (desogestrel, gestodene) are associated with a
higher risk of VTE relative to other progestins is controversial.
the risk of thrombosis with third-generation progestins would be lower than that with
other progestins because they have more beneficial effects on HDL. However, most
studies that compared the risk of thrombosis with third-generation progestins to
second-generation progestins found that desogestrel and gestodene are associated
with a greater VTE risk. A concern regarding fourth-generation progestin has
emerged as well with drospirenone. Studies show that among new users products
with drospirenone increase VTE risk compared with other products; adjusted hazard
ratio 95% CI is 1.77 (1.33–2.35). An increase in VTE was also found when
compared with levonorgestrel-containing products; adjusted hazard ratio 95% CI:
1.57 (1.13–2.18). Among all users, the risk of VTE was also increased with
drospirenone use; adjusted hazard ratio 95% CI is 1.74 (1.42–2.14), and adjusted
hazard ratio 95% CI is 1.45 (1.15–1.83) when compared with levonorgestrel.
December 2011, FDA voted that the benefits outweigh the risks of using
drospirenone products and recommended labeling changes to highlight VTE risks.
In April 2012, the FDA also published a safety communication regarding a possible
increased risk of thrombosis with drospirenone-containing products.
risk may be increased, the overall rate of thrombosis is still low. All patients using
CHCs should be counseled about the VTE warning signs (Table 47-2).
S.F. does not have a history of clotting disorders or previous clots. Therefore, she
is still a candidate for CHCs. Her smoking status, however, puts her at higher risk for
VTE. If she experiences a VTE while taking CHCs, a progestin-only method or
nonhormonal contraceptive method should be recommended and the CHC
Combined hormonal contraceptives appear to increase blood pressure. Small studies
have found systolic blood pressure to increase by 7 to 8 mm Hg and diastolic blood
pressure to increase by 6 mm Hg in normotensive or mildly hypertensive women, and
these women may have poorer blood pressure control.
26,27 Other studies have shown
differing results on whether women with hypertension who use COCs are more likely
to suffer an MI than nonusers.
6,28 A small study of adolescent women showed similar
systolic and diastolic blood pressures in users versus nonusers.
The underlying mechanisms for CHC-induced hypertension may be sodium and
water retention and increased renin activity.
30,31 Hypertension secondary to COCs
may develop slowly during 3 to 36 months and may not decline for 3 to 6 months
32 Women with controlled hypertension may attempt a trial
of CHCs with blood pressure monitoring; however, progestin-only contraceptives
have not been shown to increase blood pressure and may be preferable for women
with uncontrolled hypertension.
Pill Early Danger Signs (ACHES)
Abdominal pain (severe) Gallbladder disease, hepatic adenoma, blood clot,
Chest pain (severe), shortness of breath, or coughing
Blood clot in lungs or myocardial infarction
Headaches (severe) Stroke, hypertension, or migraine headache
Eye problems: blurred vision, flashing lights, or
Stroke, hypertension, or temporary vascular problem
Severe leg pain (calf or thigh) Blood clot in legs
S.F.’s blood pressure is not elevated at 122/72 mm Hg. Therefore, she is still a
candidate for CHCs. If her blood pressure were greater than 140/90 mm Hg, a
nonhormonal method or a progestin-only contraceptive would be a preferred form of
Combined oral contraceptives have been associated with benign liver tumors,
hepatic adenomas, and liver cancer.
3,33 The risk of liver cancer is low, and COCs are
thought to cause only a modest increase in risk.
33,34 A European study found a small,
statistically significant increase in the risk of liver cancer in women without cirrhosis
and without hepatitis B or C, which are the types of women that usually use COCs. In
this study, COC use in these women increased the risk of liver cancer by 1 case/1.5
34 S.F. should be reassured that it is very unlikely for her to
develop benign or malignant liver tumors associated with COC use.
Generally, low-dose COCs do not alter glucose tolerance.
of gestational diabetes like S.F’s sister and those with a strong family history of
diabetes in parents or siblings are at greater risk for COC-induced glucose
26 Combined oral contraceptives have complex effects on carbohydrate
metabolism. Progestins decrease and estrogens increase the number of insulin
receptors on the cell membrane. Progestins also may alter insulin receptor affinity.
The different progestins in CHCs have different propensities to induce glucose
intolerance. Desogestrel seems to have the best glucose values compared with other
progestins, but insulin results are not consistent.
Results of one controlled, randomized, prospective study showed no adverse
effect on carbohydrate or lipid metabolism in women with a history of gestational
diabetes after 6 to 13 months of low-dose CHC use.
36 Both the users and nonusers
showed a significant and similar deterioration in glucose tolerance with an overall
prevalence of 14% impaired glucose tolerance and 17% diabetes mellitus. The
authors concluded that low-dose COCs could be prescribed safely and that serum
lipids and glucose tolerance should be monitored closely, regardless of
For women with diabetes, the World Health Organization recommends avoiding
COCs if they have been diabetic for more than 20 years or they have end-organ
damage such as retinopathy, neuropathy, or nephropathy.
diabetes, CHC use may protect against developing diabetes. One large prospective,
observational study found that women who used COCs had lower fasting glucose
levels and lower odds of developing diabetes.
S.F.’s sister having a history of gestational diabetes does not preclude S.F. from
using a CHC at this time. Preferably, S.F. should start on a low-dose CHC.
The incidence of gallstones has been reported to increase with COC use; however,
conflicting data exist. Estrogens and progestins may contribute to bile stasis and
gallstones by reducing cholesterol clearance and altering bile acid composition.
The incidence of gallbladder disease has been reported to increase during the first
year of use but then to decline steadily to a rate lower than that of control women.
Conversely, in another large study, long-term COC users experienced slightly lower
rates of gallbladder disease than nonusers.
In addition, another study found that
women who had ever used COCs were not more likely to have symptomatic
gallstones, but current and long-term users were. An analysis of 482 women with
benign gallbladder disease from the Oxford/Family Planning Association
contraception study concluded that it is unlikely that COCs cause gallbladder
The newer COCs with lower progestin and estrogen concentrations should have
little effect, if any, on gallstone formation in normal patients. Women who are obese,
young, or long-term users of COCs may be the most likely to develop gallstones. At
this time, this is not a concern of S.F. in starting COCs.
CASE 47-1, QUESTION 3: S.F. has decided to quit smoking. Based on her past medical history, she is a
candidate for CHCs and indicates she wants to start a COC. Which COC should be selected for her?
Selecting a COC for S.F. can be confusing because of the multitude of products
available, the lack of studies directly comparing products, and health insurance
medication formulary restrictions. The failure rate of COCs ranges from 0.3% with
perfect use to 9% with typical use (Table 47-1).
The COCs are available in varying strengths of estrogens and progestins. Table
lists the brand name and generic COCs in the United States. Almost all
COCs available in the United States contain the synthetic estrogen, EE. Doses of EE
generally range from 10 to 50 mcg with 10- to 25-mcg formulations considered very
low dose, 30- to 35-mcg formulations, low dose, and 50-mcg formulations, high
dose. Mestranol, another estrogen available in the United States and used
internationally, is an inactive prodrug that is hepatically metabolized to EE.
Mestranol 50 mcg has approximately the same activity as EE 35 mcg.
valerate is a third estrogen available in one oral formulation. The formulation of
estradiol valerate 2 to 3 mg with 2 to 3 mg of dienogest was compared against EE 20
mcg with levonorgestrel 100 mcg in clinical trials.
The COCs also contain one of the following progestins: ethynodiol diacetate,
desogestrel, dienogest, drospirenone, levonorgestrel, norethindrone, norethindrone
acetate, norgestimate, and norgestrel (a mixture of dextronorgestrel and
levonorgestrel; dextronorgestrel appears to be progestationally inert compared with
3 Progestins differ significantly in their progestational potency and in
the extent of their metabolism to estrogenic substances. Progestins have both
estrogenic and antiestrogenic effects. Because the progestins have a chemical
structure similar to that of testosterone, they also have varying degrees of androgenic
53 Minor structural changes in all of the progestins may lead to
significant changes in their progestational, estrogenic, antiestrogenic, and androgenic
activities, which may affect patients differently (Table 47-4).
unique progestin because it has antiandrogenic and antimineralocorticoid properties.
Drospirenone is chemically similar to the potassium-sparing diuretic spironolactone,
and therefore, may increase potassium levels. Drospirenone should be used with
[ACE] inhibitors, heparin, potassium-sparing diuretics, aldosterone antagonists, and
Because no COC has been shown to be superior to the others, any COC with less
than 50 mcg of EE can be used for patients who are COC candidates.
information in Figure 47-1 may be used to select an initial COC for most patients and
to change formulations when side effects necessitate an alternative choice.
body weight (>70.5 kg) has been associated with increased COC failure.
were heavier, a COC with a higher dose of EE (e.g., 35 mcg) would be a better
option. Any pill containing less than 50 mcg EE can be used for S.F. because she is a
healthy woman without medical complications or active medications.
Oral Contraceptives and Relative Progestin, Estrogen, and Androgen
Low Low Low Amethia Lo, Camrese
Amethyst Low Low Low Amethyst is a 1-year
Estarylla, MonoLinyah, MonoNessa,
Intermediate Low Intermediate Introvale, Jolessa, and
Cryselle, Elinest, LowOgestrel
Intermediate Intermediate Intermediate
Intermediate High Intermediate
High Low Intermediate “Fe” or “FE” contains
Norethindrone Gildess 1.5/30, Gildess High Low High “Fe” contains 75 mg
High Low Low Only 2 days of placebos,
Zovia 1/50E High Intermediate Low
No data No data No data “Fe” contains 75 mg
No data No data No data Lo Loestrin Fe and Lo
supplementation, FDAapproved use for
properties, FDAapproved use for
Safyral No data Intermediate None
Necon 10/11 Intermediate High Low
Ortho Tri-Cyclen Lo Low Low Low
Ortho Tri-Cyclen, TriEstarylla, Tri-Linyah,
TriNessa, TriPrevifem, Tri-Sprintec
Low Intermediate Low FDA-approved use for
High Low Intermediate Estrophasic (estrogen
content changes), FDAapproved use for
Natazia No data Low No data Has 2 placebo pills, 2
Quartette Intermediate Low Intermediate Has 91 pills, 42 contain
Low None Low No placebos, 28 days of
EE, ethinyl estradiol; FDA, US Food and Drug Administration; PMDD, premenstrual dysphoric disorder.
Source: Facts and Comparisons eAnswers. http://online.factsandcomparisons.com/index.aspx. Dickey RP.
Estrogenic, Progestogenic, and Combined Effects of Oral Contraceptive Pills
Achieving Proper Hormonal Balance in an Oral Contraceptive
Excess Deficiency Excess Deficiency
aResult of androgenic activity of progestins.
Source: Facts and Comparisons eAnswers. http://online.factsandcomparisons.com/index.aspx.
LENGTH OF ACTIVE HORMONE: 21-, 24-, OR 28 DAY
The COCs are available in a variety of cycle lengths. The most common is the 28-day
pack that contains 21 days of active pills (pills that contain estrogen and progestin)
followed by 7 days of placebo pills. Some newer products contain 24 days of active
pills followed by 4 days of placebo. Combined hormonal contraceptives with 4 days
of placebo may shorten menses and minimize the hormonal withdrawal side effects
(e.g., headaches, mood changes) that some women experience during the placebo
It is also possible that efficacy is improved; however, this has not been proven in
The 21-day pill packs contain only the active pills. Most patients are instructed to
take one pill daily for 21 days and then take nothing for 1 week. Many clinicians
prefer the use of 28-day pill packs to minimize confusion; the patient takes one pill
daily regardless of whether it is an active or placebo pill. After taking the last pill of
a 28-day pack, the patient should begin a new pack the next day. However, when
continuous ovarian suppression is indicated to treat estrogen-dependent disorders
such as endometriosis, the 21-day cycle products are preferred to facilitate taking
active pills continuously. Alternatively, the placebo pills could be removed from 28-
day cycle packs. S.F. will not be taking COCs continuously, so a 24- or 28-day pack
MULTIPHASIC ORAL CONTRACEPTIVES
CASE 47-1, QUESTION 4: Should S.F. start a monophasic or multiphasic COC? What are the advantages
and disadvantages of the monophasic versus multiphasic COC?
COCs have varying amounts of hormones in the active pills, which can be divided
in phases that include monophasic, biphasic, triphasic, or quadriphasic (Table 47-3).
Monophasic COCs contain the same dose of estrogen and progestin in each active
pill throughout the pill pack, whereas multiphasic COCs have varying amounts of
hormones. Because of metabolic and physiologic effects related to the progestin
component of COCs, multiphasic products were initially formulated to contain less
progestin overall. Some products, however, are now marketed with varying amounts
of estrogen to reduce the overall exposure to estrogen or to minimize estrogen
withdrawal side effects (e.g., norethindrone/EE [Tri-Legest 21 and Tri-Legest Fe
A biphasic formulation usually contains a certain amount of progestin and estrogen
for the first half of the cycle, then a different amount for the second half, and then a
week of placebos. Triphasic formulations have a different amount of hormones for
each of the 3 weeks of active pills. No studies, however, show a superiority of one
triphasic over another or compared with monophasics. The reduced progestin content
is desirable for women with complaints of progestin-associated side effects (e.g.,
increased appetite, acne, weight gain) or women with cardiovascular disease or
3 Women with side effects related to progestin deficiency
(e.g., late-cycle bleeding) or conditions necessitating progestin dominance (e.g.,
benign breast disease) may do better with monophasics. Recently, a quadriphasic
COC (Natazia) became available, and it contains four different amounts of hormones
47 Advantages of the product remain to be seen, but it may
help decrease hormone withdrawal side effects and intermenstrual bleeding.
One drawback associated with triphasic and quadriphasic COC use is the
confusion caused by the different-colored pills in each of the three different phases,
making the missed-dose instructions more complicated. Monophasics are preferred
for women who will be taking COCs continuously (i.e., skipping the placebo pills)
because of the same weekly hormone content.
Other unique formulations include Mircette (see Table 47-3 for generic names),
which is classified more appropriately as monophasic because the hormone content
is consistent throughout the 21-day cycle like other monophasic formulations, but
sometimes referred to as biphasic because it does not contain 7 days of placebos. It
provides a unique regimen containing 21 days of 0.15 mg of desogestrel plus 20 mcg
of EE, then only 2 days of placebo, followed by 5 days of 10 mcg of EE alone.
patient does not need to take missed 10-mcg EE doses or use a backup method when
those specific pills are missed. Adding low-dose estrogen for 5 days during the
typical placebo week helps minimize breakthrough bleeding with this product and
may be useful for patients who have estrogen-deficiency symptoms such as headaches
during the hormone-free week. Because S.F. has not been on a CHC before and does
not have a history of side effects associated with COCs, she may be started on any of
menses each year. She is interested in this approach. Is this a reasonable option for S.F.?
Continuous- or extended-cycle COC regimens (i.e., skipping the placebo pills and
taking no break between pill packs, thus having no menses) are often prescribed in
women with underlying conditions including anemia, dysmenorrhea (less cramps
with fewer menstrual cycles), menorrhagia (heavy menstrual bleeding), and
endometriosis (to decrease hormone fluctuations that affect endometrial tissues).
addition, for convenience and lifestyle reasons, many women prefer to take COCs
continuously to minimize the number of menstrual periods. Regardless of the reason,
any woman who is a candidate for CHCs can use them continuously.
Any CHC (e.g., pill, patch, vaginal ring) may be used continuously; however, from
the COCs, monophasic pills are recommended because of the consistent hormone
content throughout the cycle. Any duration of continuous pill use is acceptable, but
many providers recommend that patients take the active pills for 3 to 4 months (3–4
pill packs) and then stop COCs for 2 to 7 days. Alternatively, providers may
prescribe COCs that are specifically packaged for continuous use (e.g., Amethyst,
Camrese Lo). Patients should be informed that continuous COC use usually results in
more breakthrough bleeding or spotting than traditional COC dosing regimens, with
up to 41% of women experiencing some form of irregular bleeding in the first few
months of the one-year regimen.
Concerns raised with extended-use regimens include harmful effects on the
endometrium; however, one study showed no harmful changes to the endometrium
57 Long-term side effects of the extended regimens are still
being studied. If breakthrough bleeding continues beyond 6 months of continuous
COC use, a pelvic examination may be considered. If S.F. is willing to tolerate more
irregular bleeding during the first 6 months of continuous COC use, then the
extended-cycle regimen may work for her.
CASE 47-1, QUESTION 6: What instructions should be given to S.F. about her COC?
WHEN TO START ORAL CONTRACEPTIVES
S.F. should start the first cycle of COCs according to the manufacturer’s package
instructions or according to one of the following recommendations:
Quick start: Take the first COC tablet as soon as possible regardless of cycle day.
Day 1 start: Take the first tablet in the COC pack on the first day of menses.
Sunday start: Take the first tablet in the COC pack on the first Sunday after the
beginning of menstruation. If menses begins on Sunday, start that day.
The quick start method is not described in COC package inserts; however, this
method is used by family planning providers.
58,59 The quick start method can
minimize the confusion that many patients have about when to start their first pack
and can increase adherence. Also, the quick start method provides contraceptive
protection sooner and would, therefore, likely lower the risk of unintended
pregnancy. More research on and awareness about this method are needed for it to be
used routinely by all healthcare providers.
WHEN TO USE A BACKUP METHOD OF CONTRACEPTION
Some clinicians recommend that a woman use an alternative method of contraception
for the entire first COC cycle. Others believe that alternative methods of
contraception are unnecessary if the COC is started on or before the fifth day of the
menstrual cycle. Most COC package inserts with the exception of Natazia (estradiol
valerate/dienogest) state that a backup method of contraception (e.g., male or female
condoms, spermicides, diaphragms) is not necessary if patients use the day 1 start
If patients use the Sunday or quick start methods, backup contraception
should be used for the first week of the COC cycle. A backup method is also
recommended when doses are missed, as described in the following section. S.F. has
decided to use the quick start method, so she will need to use another method of
contraception for her first week of COC use.
COC ADMINISTRATION AND MISSED DOSE INSTRUCTIONS
S.F. should take her COC at the same time each day. Nausea may be prevented or
alleviated by taking the dose at bedtime or with food. The best time to take COCs
depends on the patient. The optimal time for S.F. is the time when she will have the
fewest problems remembering to take her pill each day.
If a woman forgets to take one pill, she must take it as soon as she remembers and
refer to the patient instructions in the package insert for further information.
unique formulations such as estradiol valerate/dienogest (Natazia) have more
specific recommendations based on the cycle day missed. If she is taking Natazia, she
should be referred to the package insert for information (see
http://www.natazia.com), as the advice varies from that listed below.
For the majority of COCs, most manufacturers recommend that if she forgets to
take one pill, she should take two pills on the day she remembers (e.g., if she forgets
her pill on Monday, she should take two pills on Tuesday). Then she should take the
remaining pills as usual. A backup method of contraception is not necessary. If she
misses two pills in a row in week 1 or 2 of her pack, she must take two pills on the
day she remembers and two pills the next day. She should use an alternative method
of contraception for 7 days after missing the pills and may consider emergency
If a woman misses two pills in a row during the third week (for day 1 starters), she
must discard the rest of the pack, start a new pack on that same day, and use an
alternative contraceptive method for 7 days. For Sunday starters, she should keep
taking one pill every day until Sunday, then start a new pack on Sunday. She must use
an alternative method of contraception for 7 days after missing the pills and may
consider emergency contraception. She may miss her menstrual period this month.
If a woman misses three or more pills in a row during the first 3 weeks (for day 1
starters), she must discard the rest of her pack, start a new pack that same day, and
use an alternative method of contraception for 7 days; Sunday starters should keep
taking one pill every day until Sunday, start a new pack on Sunday, and use an
alternative method of contraception for 7 days after missing the pills, and they may
consider emergency contraception. Women may not have a menstrual period this
month. If two pills are missed from a low-dose COC (less than EE 30 mcg), some
references suggest following the instructions as if three pills were missed.
references and organizations may cite different recommendations. The
recommendations described here are recommended by manufacturers.
CASE 47-1, QUESTION 7: S.F. returns to the clinic 3 months later and is very concerned about getting
possible dose. What do you tell her?
The contraceptive patch has an estimated failure rate of 0.3% with perfect use and
9% with typical use (Table 47-1). The contraceptive patch (Ortho Evra, Xulane)
contains 6 mg of norelgestromin and 750 mcg of EE. It was originally formulated to
transdermally deliver 150 mcg of norelgestromin and 20 mcg of EE daily into the
systemic circulation; however, higher doses of ethinyl estradiol are now thought to be
60 The patch is a 1.75-inch square with rounded corners and is
beige and thin. One patch is applied each week for three consecutive weeks for a
total of three patches used, followed by 1 week with no patch. The day of the week
the patch is applied is called the patch change day. Then this cycle is repeated.
Menses should begin during the patch-free week. If a woman wants to avoid menses,
the patch-free week may be skipped by applying a new patch on week 4 for an
The contraceptive patch may be worn on the buttock, abdomen, upper torso, or
60 The patch should not be applied to the breasts to prevent direct
administration of estradiol to the breast tissue. To minimize irritation from the
adhesive, S.F. should rotate the patch application sites and not apply the patch to the
same location within each month. When applying the patch, S.F. should select the
application site and be sure it is clean and dry. She should press firmly on the patch
for 10 seconds and trace her finger around the edge of the patch to be sure it adheres
securely to the skin. The patch should stay attached during usual activities, including
exercising, swimming, and bathing. If the patch falls off and is off less than 24 hours,
she should reapply it or apply a new one as soon as possible, and her patch change
day will stay the same. No backup contraception is needed. If the patch is off for
more than 24 hours, she should start a new cycle of patches, and she will have a new
patch change day. She should use backup contraception for 1 week.
The patch may be started using the quick, Sunday, or day 1 start method, and the
recommendations for backup contraception are the same as described earlier with
If S.F. forgets to start the first patch of a new cycle, she should apply it as
soon as she remembers. This day will become her new patch change day, and she
should use backup contraception for 1 week. If she forgets to change the patch for 1
or 2 days during week 2 or 3, she should apply a new patch as soon as she
remembers. This becomes her new patch change day. No backup contraception is
needed. If she forgets to wear the patch for more than 2 days, she should start a new
cycle as soon as she remembers. She will need to use backup contraception for 1
week and will have a new patch change day.
The effectiveness of the patch is reduced in patients weighing more than 90 kg and
should not be used alone for prevention of pregnancy in these women.
weigh more than 90 kg, which does not preclude her from using this method.
The most common side effects reported with the patch are breast tenderness,
headache, application site reaction, and nausea. Most risks and benefits with the
contraceptive patch are thought to be similar to COCs. One notable difference is the
rate of VTE. A small pharmacokinetic trial found that overall monthly serum levels
of EE are significantly higher in patch users compared with ring or COC users.
With the patch, the peak levels of estrogen are lower, but the steady-state
concentrations are higher. It has been noted that the patch provides 60% more ethinyl
estradiol than an oral 35-mcg tablet.
60 This raised concern that the patch may have a
higher incidence of VTE than the other methods; however, it is controversial. One
study found no difference in the rate of nonfatal VTE in patch versus COC users,
whereas another study found a doubling of VTE risk in patch users compared with
62–65 The package insert for the transdermal patch was modified to include
63 Future studies may find that there are other differences in
certain risks or benefits between the patch and pill. Given the higher amounts of EE
and controversy surrounding VTE with the transdermal patch, this may not be the
most appropriate method for S.F. based on her concerns of VTE associated with
The failure rate for the contraceptive ring is also 0.3% with perfect use and 9% with
3 The contraceptive ring (NuvaRing) delivers 120 mcg of
etonogestrel and 15 mcg of EE daily through the vaginal mucosa.
flexible, transparent, and has a diameter of just over 2 inches. The ring is inserted
vaginally and kept in place for 3 weeks in a row. After 3 weeks, the ring is removed
for 1 week, and then a new ring is inserted (see
http://www.spfiles.com/pinuvaring.pdf). For extended use, the ring-free week may
be skipped by inserting a new ring on week 4.
The ring may be placed anywhere in the vagina, so S.F. does not need to worry
66 To insert the ring, she should compress it so the opposite
sides of the ring are touching, and gently insert it into the vagina.
If she feels discomfort with the ring, it has probably not been inserted into the
vagina far enough. Most women do not feel the ring once it is in place. To remove the
ring, S.F. should grasp the ring between two fingers or hook one finger inside the ring
and pull it out. Menses will usually begin within 3 days of removing the ring. If the
ring slips out, it should be rinsed with lukewarm water and reinserted. If the ring is
out for less than 3 hours, backup contraception is not needed. If the ring is out for
more than 3 hours, backup contraception should be used for 1 week. According to the
manufacturer, if the ring has been left in the vagina for longer than 3 weeks but no
more than 4 weeks, S.F. should remove it, wait 1 week, then reinsert a new ring. The
ring is formulated to contain approximately 35 days of medication but should not be
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