Clinicians frequently provide
contraceptive counseling to
women who have medical
conditions that may be exacerbated
by pregnancy or who
have medical comorbidities that necessitate
the use of potentially teratogenic
medications.1 Effective counseling requires
up-to-date knowledge about hormonal
contraceptive methods that differ
in hormone dosage, cycle length, and
hormone-free intervals and are delivered
by oral, transdermal, transvaginal,
injectable, or implantable routes. Effective
counseling also requires an understanding
of a woman's preferences and
medical history, as well as the risks,
benefits, side effects, and contraindications
of each contraceptive method.
Part 1 of this review focuses on combined
hormonal contraceptives (CHCs)
only, with special consideration to the
use of contraception in women with
medical comorbidities.
back to top
CASE EXAMPLE:
A Twenty-Something Migraneur
A 29-year-old woman with a history of
migraines without aura asks her physician
whether she should begin oral
contraceptives (OCs), stating that she is
willing to take a daily pill. She reports
dysmenorrhea and bloating for the 3
days leading up to her menses, which
she describes as "heavy" and lasting for
6 days. This patient smokes 3 cigarettes a
day, and her mother was diagnosed with
breast cancer at age 65 years.
Does this patient have any contraindications
to taking OCs? What side effects
should you discuss with her prior
to prescribing OCs?
A complete medical history is important
in deciding whether OCs would offer this
patient benefi t or substantial risk. Indeed,
most contraindications to hormonal contraception
can be ruled out during the
history-taking. Although a pelvic examination
is not necessary before prescribing
hormonal contraception, a focused
physical examination, including blood
pressure (BP) measurement, may guide
your decision.2
CHCs can be used safely in women
who have a range of medical conditions.
These conditions include patients who
have well-controlled hypertension; uncomplicated
diabetes; various connective
tissue disorders such as rheumatoid
arthritis and systemic lupus erythematosus
without antiphospholipid antibodies;
and uncomplicated liver disease.3,4
Current guidelines suggest that women
who have migraines without aura, such
as the patient presented here, can safely
take OCs if they are younger than age 35
years and have no contraindications to
use.3,4 This patient smokes 3 cigarettes a
day, however, and she should be counseled
to stop smoking.
A family history of breast cancer, as in
the case of this patient, is not a contraindication
to prescribing OCs.5 According
to the American College of Obstetricions
and Gynecologists (ACOG) Practice Bulletin
No. 73, a family history of BRCA1
or BRCA2 mutations should not preclude
OC use.3
Most contraindications to OCs are due
to the estrogen component. Whereas the
estrogen schedule may differ depending
on the CHC delivery method (oral,
transdermal, intravaginal), the risks
and benefi ts are generally believed to be
similar to that of OCs and are grouped
together in the World Health Organization's
(WHO) updated Medical Eligibility
Criteria for Contraceptive Use.4
Clearly, there are women for whom
OCs should not be prescribed.3,4 These
include women who have a history
of migraines with aura due to the increased
risk of stroke.6,7 Women with
uncontrolled hypertension or who are
smokers older than age 35 years also
should not be prescribed OCs because of
the increased cardiovascular risk.6,8,9
OCs are contraindicated in several
other groups of women. These include
diabetic patients with end-organ damage;
a personal history of breast cancer or
estrogen-dependent tumor; unexplained
vaginal bleeding; active liver disease; a
history of a thromboembolic disorder; or
prior venous thromboembolism (VTE).3,4
OCs are also contraindicated in women
who are breast-feeding within 6 weeks
of delivery.3,4
OCs may be prescribed to certain other
groups of women, but they must be prescribed
with caution. For example, CHCs
have been shown to elevate systolic and
diastolic BP by about 8 and 6 mm Hg,
respectively10; therefore, caution should
be used when initiating OCs in women
who already have elevated BP, especially
women older than age 35 years. Guidelines
from both WHO and ACOG suggest
that the risks of OCs outweigh the benefi
ts if BP is uncontrolled.3,4
ACOG recommends that the use of
OCs in women with diabetes be limited
to nonsmoking women younger than
age 35 years, who are otherwise healthy
and show no evidence of hypertension,
nephropathy, retinopathy, or other vascular
disease.3 Women with mild hyperlipidemia
who do not have other cardiovascular
risk factors can be prescribed
OCs if their low-density lipoprotein cholesterol
is less than 160 mg/dL.3
The side effects of OCs should be discussed
with patients considering OC use.
The most common side effects include
nausea, headaches, breast tenderness,
and breakthrough bleeding. A more serious,
but less common, side effect of OC
use includes a 4-fold increase in the relative
risk of VTE compared to women who
do not use OCs; this risk may be higher
in obese women.8 Certain third-generation
progestins (eg, desogestrel) and the
fourth generation progestin drospirenone
may further increase VTE risk compared
to other progestins.11-15 This increase is
lower, however, than the risk of VTE associated
with pregnancy, and the absolute
risk of VTE among OC users remains
small. It is also important to counsel patients
that OCs do not offer protection
against sexually transmitted infections.
What are the noncontraceptive benefi ts of
OCs from which this patient may benefit?
Patients may experience several benefits
from OC use in addition to pregnancy
prevention.16 In the case of this
patient, OCs may reduce dysmenorrhea
and menorrhagia, and offer improved
cycle control and regularity. OCs are often
first-line treatment for women with
dysfunctional uterine bleeding. Diminished
intensity and duration of menses
also reduces iron-defi ciency anemia.
Women with polycystic ovary syndrome
(PCOS) may receive particular
benefits from OCs, such as improvement
in acne and hirsutism, as well as
regulation of menses. These effects are
secondary to the elevation in sex hormone-
binding globulin, which reduces
circulating free testosterone and ameliorates
many androgenic effects.
OCs containing the progestin drospirenone
have antiandrogen and antimineralocorticoid
activity that may result
in less weight gain and less water retention,
and may also offer even greater
reduction in acne and hirsutism.17 OCs
also have demonstrated signifi cant risk
reduction for endometriosis, ovulatory
pain, ovarian cysts, benign breast disease,
premenstrual syndrome, premenstrual
dysphoric disorder (PMDD),16,17
and ovarian and endometrial cancers.18,19
back to top
Based on this patient's symptoms
and contraceptive needs, would you
choose an extended-cycle or conventional
OC? What are the options and
how do they differ?
It is important to discuss a patient's
preferences for menstrual frequency,
as well as her tolerance for scheduled
and unscheduled bleeding. A patient's
response to these issues will help to decide
which OC will best
fit her needs.
Traditional OC regimens
include 21 days of
hormones, followed by a
7-day, hormone-free interval
(HFI), which can result
in hormone withdrawal
symptoms in women who
are sensitive to fluctuating
hormone levels. With
extended-cycle regimens,
the HFI is shortened
or eliminated to manage
common menstrual
symptoms (eg, headaches,
tiredness, bloating, excessive
bleeding, menstrual
pain) more effectively, as
well as improve OC compliance.
17,20-32
Women with hormone
withdrawal symptoms or
severe dysmenorrhea may benefit from
fewer periods a year and shorter HFIs.
Examples of extended-cycle OCs that
offer relief from both withdrawal symptoms
and dysmenorrhea include Seasonique
® (150 mcg levonorgestrel [LNG]/30
mcg ethinyl estradiol [EE] and 10 mcg EE;
no HFI) (Teva Women's Health, Inc) and
Lybrel® (90 mcg LNG/20 mcg EE; no HFI)
(Pfi zer, Inc).* Lybrel is the fi rst FDA-approved
OC in which active pills are taken
365 days a year. Because there are no
placebo pills or HFI, Lybrel is an option
for women who do not want scheduled
monthly periods. The safety and effi cacy
of Lybrel are similar to that of other OCs,
and women can expect rapid return to
fertility after its discontinuation.33,34
It remains unknown whether the additional
weeks of hormone exposure increase
the risk of VTE in extended-cycle
users. However, a systematic review of
extended-cycle versus traditional 28-day
cycle OCs found similar efficacy and
safety, and no difference in patient adherence.
35 Health care providers should educate
patients on the benefi ts and potential
risks of extended-cycle contraception and
inquire as to preference for monthly menses.
If the patient in this case example
seeks fewer periods per year, we would
prescribe an extended-cycle OC.
When prescribing an OC, another
thing to consider is its progestin component
and how it may help combat specific menstrual or premenstrual symptoms.
OCs containing drospirenone, a
synthetic progestin chemically related
to spironolactone, may cause less weight
gain and reduced water retention, and
may also offer greater decrease in acne,
hirsutism, and PMDD compared to traditional
OCs.17,27,29,34
What if the patient is interested in
receiving the benefits of a combined hormonal
method but is unwilling to take a
daily pill?
If a patient has difficulty remembering
to take a daily OC, 2 other delivery
options are available: the OrthoEvra®
transdermal contraceptive system
(6,000 mcg norelgestromin [NRGM]/750
mcg EE, releasing 150 mcg NRGM/20
mcg EE per 24 hours) (Janssen Ortho,
LLC) and the NuvaRing® vaginal ring
(11,700 mcg etonogestrel [ETG]/2,700
mcg EE, releasing 120 mcg ETG/15 mcg
EE per 24 hours (Organon, a subsidiary
of Merck & Co, Inc).
Although the patch is an effective contraceptive
method, studies have shown
decreased effectiveness in obese women
(>90 kg).35 The side effects, cardiovascular
risks, and contraindications of the
patch are similar to other CHCs,3,4 except
for the risk of VTE. Whereas retrospective
studies to assess the risk of contraceptive
patch-associated VTE provided
confl icting data, at least 2 studies showed
an approximate 2-fold increase in risk
compared to women taking OCs.36-38
These studies warranted the FDA-mandated
update to the Ortho Evra label to
refl ect the higher risk of VTE.39 Of note,
VTE risk with the Ortho Evra patch is
lower than VTE risk during pregnancy.40
NuvaRing is a soft, plastic ring that is inserted
vaginally for 3 weeks. The HFI is a
ring-free week. The vaginal ring contains
enough hormones to be effective for 4 to 5
weeks. Therefore, some women may chose
to use a ring for 4 weeks before having an
HFI. Each ring releases about half the level
of hormones as the average OC without affecting
efficacy. This may be particularly
benefi cial for women who are intolerant of
the side effects of traditional OCs.
Unlike the contraceptive patch,
weight does not affect the efficacy of
the vaginal ring. Nearly all women fi nd
the ring easy to insert and remove and
found tolerability to be comparable to
that of OCs.41,42 The large majority of
partners of vaginal ring users rarely felt
the ring during intercourse.42 The vaginal
ring has similar side effects, cardiovascular
risks, and contraindications as
other CHCs,4 with the only unique side
effect being a possible increase in leukorrhea.
41,42 If the ring falls out (2.5%
of women experience 1 event/year), patients
can be counseled to rinse and replace
it, without change in efficacy.41
back to top
CONCLUSION
A comprehensive, up-to-date knowledge
of currently available CHC options is essential
for all health care providers caring
for reproductive-aged women. Careful
consideration and history-taking is
especially important in women with
medical comorbidities to determine if
any contraindications to CHC use exist
and which method and mode of delivery
is appropriate for the individual patient.
Traditional OCs have a long track record
of safety, acceptability, and efficacy,
with well-described contraceptive and
noncontraceptive benefits. Extendedcycle
CHCs offer similar safety and efficacy,
and may also reduce unwanted
symptoms (eg, headaches, bloating, mood
changes) by preventing endogenous estradiol
production with shorter HFIs.
Discussing a patient's preferences
for menstrual frequency, as well as her
tolerance for scheduled and unscheduled
bleeding, is important in deciding
whether a traditional or extended-cycle
OC will best fit her needs. The contraceptive
patch and vaginal ring are CHC
options if a woman cannot take a daily
pill but seeks the benefi ts of a CHC. A
brief summary of CHCs is provided in
the Table.
This is part 1 of a 2-part article. In the
November 2011 issue, part 2 will focus
on available progestin-only contraceptive
options in women with medical comorbidities.
The authors report no actual or potential
conflict of interest in relation to this
article.
back to top