JOURNAL OF WOMEN’S HEALTH

Volume 17, Number 1, 2008

© Mary Ann Liebert, Inc.
DOI: 10.1089/jwh.2007.0685

Conversation with the Experts

Toward Optimal Health: Advances in

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Contraceptive Options

JODI R. GODFREY, M.S., R.D., and PATRICIA J. SULAK, M.D.

Dr. Sulak is Professor of Obstetrics and Gynecology at Texas A&M Health Science
Center, College Station, Texas, and Director of the Division of Ambulatory Care and
of the Sex Education Program at the Scott & White Clinic Memorial Hospital in Tem-
ple, Texas. Ms. Godfrey is a contributing editor and freelance medical writer in Mont-
clair, New Jersey.
Journal of Women's Health 2008.17:11-14.

I N A 2004 HARRIS INTERNATIONAL STUDY commis-

sioned by the Association of Reproductive
Health Professionals, more than 25% of women
indicated dissatisfaction with their current form
of contraception. Among those who were satis-
fied with the method they were using, more than
one third (37%) were interested in discussing al-
ternative methods with their healthcare practi-
tioner.1 Fortunately, there is now a variety of new
options, many with benefits beyond birth control.
The combined oral contraceptive (COC) pill
represents one of the most researched medical
therapies available, having amassed more than 40
years of data to support its efficacy and safety for
most women. It remains the preferred reversible
method of contraception, favored by more than
80% of women in their reproductive years. The
pill is undergoing long overdue changes, includ-
ing delivery of low-dose estrogen and extended
and continuous regimens. However, contracep-
tive options go beyond the pill to include a vari-
ety of other delivery systems, such as the patch,
diaphragm, single-rod implant, intrauterine de-
vices, and the depot medroxyprogesterone injec-
tion. The form of delivery is primarily a personal
choice, as all contraceptives are effective in pre-
venting unwanted pregnancy.
Choosing a contraceptive method means ex-
amining a host of issues related to efficacy, side
effects, cost, and a woman’s risk profile for car-
diovascular disease (CVD), cancer, and potential
exposure to sexually transmitted diseases (STDs).
In addition, the pill offers many benefits beyond
avoiding conception.
This discussion with Patricia J. Sulak, M.D.,
moderated by Jodi R. Godfrey, M.S., R.D., con-
siders compliance as well as medical history and
current health status in reviewing the expanding
array of contraceptive options so that women’s
health practitioners are better positioned to en-
gage patients in a conversation that is compre-
hensive.
Given the growing list of benefits ascribed to
COCs for reasons other than avoidance of
unintended pregnancy, which contraceptive
method(s) offer the best benefit profile for
most women?
An estimated 2.5 million women needlessly
suffer debilitating symptoms every month in-
duced by a 7-day hormone-free interval that is
found in most standard OCs marketed today.2
Associated symptoms, including menorrhagia,

11
 12 CONVERSATION ABOUT ADVANCES IN CONTRACEPTIVE OPTIONS
menstrual migraines, dysmenorrhea, and breast
tenderness, cause two thirds of affected women
to contact a healthcare professional at least once
a year for ailment relief and one third to have an
average of 9.6 days of bed confinement and lost
work productivity annually. Heavy menstrual
bleeding alone contributes to an estimated $1692
in expected lost wages per affected woman and
a 6.9% reduction in total employment per year.3
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Menstrual hormone fluctuations and withdrawal
bleeding are associated with significant adverse
health measures, missed days from work as well
as compromised productivity, and negative eco-
nomic consequences. These nuisance side effects
often lead to problems with compliance, discon-
tinuation, and, ultimately, unintended preg-
nancy.
Although COCs are frequently prescribed for
anemia, pelvic pain, and dysmenorrhea, the cur-
rent regimens confer other welcome health ben-
Journal of Women's Health 2008.17:11-14.
efits, such as a reduced risk for ovarian and en-
dometrial cancers, treatment for endometriosis,
decrease in formation of ovarian cysts (particu-
larly from a continuous formula), and diminsihed
acne and hirsutism, among others. Cyclic mood
swings and symptoms related to the menstrual
cycle may be limited to mild discomfort or may
include premenstrual syndrome (PMS) or pre-
menstrual dysphoric disorder (PMDD), with sig-
nificant emotional and somatic impairment.4 Use
of a regimen with a shortened, 4-day, pill-free in-
terval has the potential to maintain a constant
level of ovarian suppression, inhibit follicle for-
mation, and decrease the incidence of hormone
withdrawal symptoms. On this basis, the appro-
priate OC can be selected, and the patient can be
monitored for satisfaction and adherence.
Despite the many advantages, compliance can
present an obstacle to use for some women. In or-
der for the pill to be effective—for all intended
benefits—it must be taken at the same time every
day, and with the extended and continuous use
regimens, there will be breakthrough bleeding, at
least initially.
The spectrum of COCs (estrogen/progestin)
which includes the 21/7, 24/4, and extended-cy-
cle pills allow the practitioner to prescribe a reg-
imen based on the patient’s medical history,
needs, and desires. The practitioner must also
consider previous success or failure with a COC
formulation, in addition to other medications and
conditions (e.g., endometriosis, menorrhagia,
seizure disorder) in exploring the best COC or al-
ternative contraceptive method. Certainly, for the
woman who asks for a reliable contraceptive that
does not require daily pill taking or forethought,
there are many good alternatives:
• An intrauterine device (IUD) with levonor-
gestrel (Mirena®, Bayer Healthcare Pharma-
ceuticals, Montvale, NJ) that is effective for up
to 5 years
• A copper IUD (ParaGard®, Duramed Pharma-
ceuticals, Pomona, NY) that can be left in place
for up to 10 years
• A single-rod implant (Implanon™, Organon
USA, Roseland, NJ) that contains etonogestrel,
which is effective for up to 3 years; however,
women may experience irregular vaginal
bleeding
• A transdermal weekly patch (Ortho Evra®, Or-
tho-McNeil Pharmaceutical, Raritan NJ) that
contains both estradiol and norelgestromin; the
patch is applied to the skin and repeated for a
total of 21 days, followed by a patch-free week
• A vaginal polymer ring (Nuvaring®, Organon
USA) containing estradiol and etonogestrel, re-
placed monthly, with 1 ring-free week
The shift away from the traditional 21/7
standard regimen and toward a COC that
essentially eliminates the menstrual cycle has
been controversial, in part because of a lack
of information. Are there sufficient data to
support this contraceptive approach as the
first choice among physicians and their
patients?
Until recently, modifications of COC regimens
have involved lowering the estrogen level and us-
ing new progestin components. The formula for
the original 21/7 cyclical regimen was created to
mimic the average menstrual cycle of 28 days—
a prescription of 21 hormone-containing pills fol-
lowed by a 7-day hormone-free interval (HFI)—
which unfortunately produces many common
menstrual complaints. Of note, nearly all adverse
complaints are significantly worse during the 7-
day HFI than during the 21 days of hormone-con-
taining pills. The avoidance of menstruation
through extended or COC administration has
gained legitimacy through its therapeutic uses.
However, a preference for amenorrhea has been
growing as well, given acknowledged advan-
tages, such as less interference with daily activi-
ties or special events, decreased expense for fem-
 CONVERSATION ABOUT ADVANCES IN CONTRACEPTIVE OPTIONS
inine hygiene products, and less menstruation-
related absenteeism from work or school.5–7 For
women who hesitate because of concerns about
menstrual buildup, producing an unnatural state,
or the possibility of pregnancy without regular
periods, reassurance about safety can allow most
women to opt to minimize or eliminate menstru-
ation until there is a desire to get pregnant.5 Thus,
the real question is not whether the 21/7-day reg-
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imen should be altered but how to alter it. Five
different formulations of COC pills have been ap-
proved recently by the Food and Drug Adminis-
tration (FDA):
• Seasonale (Duramed Pharmaceuticals), a 91-
day COC designed to allow four periods a year
• Seasonique (Duramed Pharmaceuticals), an 84-
day COC that adds low-dose estrogen to the 7
days that were previously hormone-free; a
newer version of Seasonale.
Journal of Women's Health 2008.17:11-14.
• Yaz (Bayer Healthcare Pharmaceuticals), a
24/7 COC that is also approved for acne and
PMDD
• Loestrin 24 (Warner Chilcott, Rockaway, NJ),
a 24/4 regimen with 1 mg norethindrone and
20 g ethinyl estradiol (EE), which promotes
shorter, lighter menstrual cycles
• Lybrel (Wyeth Pharmaceuticals, Collegeville,
PA), the newest approved pill, a continuous
combination regimen delivering hormones for
28 days, with no days off
Numerous studies have documented the need
for the 21/7 regimen to be modified.8 These
newer pills—either an extended or continuous
regimen—suggest the direction in which science
and practice are moving. With over 40 brands of
COC on the market, there are options to fit every
woman’s needs. It is not a one-pill-for-all situa-
tion.
When queried, health practitioners acknowl-
edge recommending extended regimens to wo-
men for reasons that go beyond contraception for
indications that include reduced frequency of
bleeding or decreased withdrawal side effects,
such as heavy bleeding, menstrual migraines,
pelvic pain (cramps), bloating, breast tenderness,
or PMS.4
As with any medical innovation, there is a nat-
ural transition that takes place as a sense of fa-
miliarity and a comfort level are established.
However, it likely will not be long before the ex-
tended or COCs become the norm.
13
Concerns about contraindications regarding
cardiovascular, cerebrovascular, and
thromboembolic diseases continue to arise
with the use of COCs. Do convincing safety
and efficacy data exist to assure their use for
the vast number of sexually active women
who are beyond having children but are not
yet at menopause?
The first COCs marketed in the United States
contained 150 g synthetic estrogen, mestranol,
which metabolizes to EE. By contrast, most cur-
rent COCs contain 35 g of EE. The dramatic
decrease in the estrogen dose has decreased COC-
related risk for myocardial infarcts, stroke, and
venous thromboembolism.9 Rather, the incidence
of cardiovascular events that occur among COC
users can be attributed to direct risk factors, such
as smoking, hypertension, diabetes, or elevated
lipids.
Does a similar risk reduction hold for breast
cancer among COC users?
Several recent studies have shown no increased
risk of breast cancer relative to COC use.10,11
There is no elevated risk for breast cancer among
women simply based on their COC use.12 Over-
all, OC use has neither a harmful nor a beneficial
effect on breast cancer mortality in the general
population; however, data on the low-dose EE
regimens will not be available for at least 10 years.
The effect of COC with regard to other cancers
is even more favorable. The risk of developing
ovarian cancer in women using COCs is at least
40% lower than among nonusers, and the level of
protection is directly proportional to the duration
of use. Similarly, scientific data convincingly
prove a lower risk of endometrial cancer for wo-
men who used COCs than for women who never
took them.11
Is there any validity to ongoing concerns
about adverse interactions between COCs and
common medications, such as antibiotics or
botanicals? Does prescribing thyroid
replacement hormone, thyroxine, require any
dosage adjustment or special consideration in
women taking both?
Any contraindications or lessening of effec-
tiveness from taking common medications, such
as antibiotics (i.e., amoxicillin, tetracycline), while
on the pill have been refuted. The only interac-
 14 CONVERSATION ABOUT ADVANCES IN CONTRACEPTIVE OPTIONS
tions of note with COCs involve seizure medica-
tions, antituberculosis therapy, and long-term use
of antifungals. Simply put, the likelihood of a
medication interaction is rare.
As for concerns about the need to adjust thy-
roxine levels, the amount of estrogen delivered in
second and third generation COCs is sufficiently
low that there is no likely effect on thyroxine. This
is supported by a small, randomized trial that
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showed low-dose COCs may increase T3, T4, and
cortisol as the result of an elevated binding to
serum globulins but with little to no change in
free thyroxine. Therefore, COCs elicit an in-
significant effect on thyroid function as well as
adrenal and blood pressure serum parameters.13
Historically, weight gain has presented an
obstacle to choosing COCs for some women.
Does this issue persist with the newer
formulations? Recent studies suggest that
Journal of Women's Health 2008.17:11-14.
obesity may reduce the biological
effectiveness of OCs. Are COCs
contraindicated for women who are obese?
The real problem is that most women tend to
gain weight over time and as they age. Taking a
hormone-based contraceptive provides a plausi-
ble scapegoat, but because the newer formula-
tions deliver low-dose estrogen, the issue of pos-
sible weight gain should no longer be considered
a valid side effect. The only exception to this may
be for women who opt for DepoProvera injec-
tions, which offer a good enough reason to leave
this contraceptive as the choice of last resort.
Data from a 2002 National Survey of Family
Growth found no association between obesity
and OC failure; however, large prospective stud-
ies are needed to confirm that obesity has no bio-
logically relevant impact on OC effectiveness.14 A
more relevant concern for women’s health practi-
tioners relates to obesity as a common symptom
of polycystic ovarian syndrome (PCOS), as are ir-
regular menstrual cycles and infertility and for
which COCs are listed as a treatment.15
REFERENCES
1. Association of Reproductive Health Professionals. In-
terest in alternate methods. Revisiting your regular wo-
men’s health care visit. Harris Interactive Poll, 2004.
2. Braunstein JB, Hausfeld J, Hausfeld J, London A. Eco-
nomics of reducing menstruation with trimonthly-cy-
cle oral contraceptive therapy: Comparison with stan-
dard-cycle regimens. Obstet Gynecol 2003;102:699.
3. Cote I, Jacobs P, Cumming D. Work loss associated
with increased menstrual loss in the United States.
Obstet Gynecol 2002;100:683.
4. Sulak PJ. Ovulation suppression of premenstrual
symptoms using oral contraceptives. Am J Manag
Care 2005;11:S492.
5. Glasier AF, Smith KB, van der Spuy ZM, et al. Amen-
orrhea associated with contraception—An interna-
tional study on acceptability. Contraception 2003;67:1.
6. Wiegratz I, Hommel HH, Zimmermann T, Kuhl H.
Attitude of German women and gynecologists to-
wards long-cycle treatment with oral contraceptives.
Contraception 2004;69:37.
7. Miller L, Hughes JP. Continuous combination oral
contraceptive pills to eliminate withdrawal bleeding:
A randomized trial. Obstet Gynecol 2003;101:653.
8. Sulak P. Continuous oral contraception: changing
times. Best Pract Res Clin Obstet Gynaecol 2007. Epub
ahead of print; accessed September 22, 2007.
9. Sidney S, Petitti DB, Soff GA, Cundiff DL, Tolan KK,
Quesenberry CP Jr. Venous thromboembolic disease
in users of low-estrogen combined estrogen-progestin
oral contraceptives. Contraception 2004;70:3.
10. Kahlenborn C, Modugno F, Potter DM, Severs WB.
Oral contraceptive use as a risk factor for premeno-
pausal breast cancer: A meta-analysis. Mayo Clin Proc
2006;81:1290.
11. Lech MM, Ostrowska L. Risk of cancer development
in relation to oral contraception. Eur J Contracept Re-
prod Health Care 2006;11:162.
12. Wingo PA, Austin H, Marchbanks PA, et al. Oral con-
traceptives and the risk of death from breast cancer.
Obstet Gynecol 2007;110:793.
13. Wiegratz I,Kutschera E, Lee JH, et al. Effect of four
oral contraceptives on thyroid hormones, adrenal and
blood pressure parameters. Contraception 2003;67:361.
14. Brunner Huber LR, Toth JL. Obesity and oral contra-
ceptive failure: Findings from the 2002 National Sur-
vey of Family Growth. Am J Epidemiol 2007;166:1306.
15. Dronavalli S, Ehrmann D. Pharmacologic therapy of
polycystic ovary syndrome. Clin Obstet Gynecol
2007;50:244.
Address correspondence to:
Jodi R. Godfrey, M.S., R.D.
Contributing Editor
Journal of Women’s Health
31 Macopin Avenue
Upper Montclair, NJ 07043
E-mail: jgodfrey31@gmail.com