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P R AC T I C E
BUL L E T I N
CLINICAL MANAGEMENT GUIDELINES FOR OBSTETRICIAN – GYNECOLOGISTS
NUMBER 110, JANUARY 2010 (Replaces Committee Opinion Number 337, June 2006)
Background
Box 1. Potential Noncontraceptive Benefits
Patients are often unaware of the noncontraceptive bene-
of Hormonal Contraception
fits of hormonal contraception, and this represents an
opportunity for counseling (2). A brief list of some com- • Menstrual cycle regularity
mon noncontraceptive benefits is provided in Box 1. • Treatment of menorrhagia
Most hormonal contraceptives combine a progestin
• Treatment of dysmenorrhea
for its contraceptive effects and an estrogen to stabilize
the endometrium and reduce unwanted spotting. Users • Inducing amenorrhea for lifestyle considerations
of progestin-only hormonal contraceptives avoid the side • Treatment of premenstrual syndrome
effects associated with the use of contraceptives con- • Prevention of menstrual migraines
taining estrogen. Progestin-only contraceptives often
can be used in women when estrogen is contraindicated; • Decrease in risk of endometrial cancer, ovarian
cancer, and colorectal cancer
however, unpredictable spotting may be problematic for
some patients. Over time, this unwanted bleeding gener- • Treatment of acne or hirsutism
ally subsides and progestin-only methods may provide • Improved bone mineral density
highly effective long-term contraception. • Treatment of bleeding due to leiomyomas
Since oral contraceptives containing 150 micrograms
of mestranol were introduced in 1960, the dose of estro- • Treatment of pelvic pain due to endometriosis
gen per pill has been reduced; currently, pills may con-
Committee on Practice Bulletins—Gynecology. This Practice Bulletin was developed by the Committee on Practice Bulletins—Gynecology with the
assistance of Robert L. Reid, MD. The information is designed to aid practitioners in making decisions about appropriate obstetric and gynecologic care.
These guidelines should not be construed as dictating an exclusive course of treatment or procedure. Variations in practice may be warranted based on the
needs of the individual patient, resources, and limitations unique to the institution or type of practice.
VOL. 115, NO. 1, JANUARY 2010 Practice Bulletin Uses of Hormonal Contraceptives 207
Most clinical trials have demonstrated that unsched- What is the evidence supporting hormonal
uled spotting or light bleeding is common in the first contraceptive use as an alternative to
3–6 months with all combined OCs. Women using hor- surgical therapy for menorrhagia?
monal contraception for menstrual regulation should be
counseled about this possible effect. Excessive menstrual bleeding (60–80 mL per cycle or
The progestin-only pill is thought to inhibit ovulation greater) if untreated can lead to iron deficiency anemia
in approximately 50% of women (39, 40). The remainder (48). It has been estimated to occur in approximately
of women using this method will continue to menstruate 10% of women of reproductive age, although as many
as 30% of women will seek treatment for this condi-
regularly. Other progestin-only methods (DMPA and levo-
tion (48–50). Combined hormonal contraceptives can
norgestrel intrauterine system) initially result in increased
reduce excessive menstrual bleeding in most affected
rates of unscheduled bleeding but lead to diminished
women and are considered a reasonable option for initial
blood loss over time as a substantial number of women
management of menorrhagia. This is particularly true in
using these methods become amenorrheic.
women who may desire future fertility because the con-
Evaluation of a continuous daily regimen of 90 traceptive effect is readily reversible.
micrograms of levonorgestrel per 20 micrograms of ethi- Menstrual blood loss is reduced by 40–50% in
nyl estradiol demonstrated that 79% reported absence of women who used cyclic combined OCs (51–53). The
bleeding by pack 13 with the incidence of breakthrough effectiveness of combined OCs may be enhanced by
bleeding decreasing progressively from initiation (41). extended cycle or continuous therapies that reduce the
Several pills also are available that extend the active number of total bleeding episodes (54, 55). Extended
pills to 24 days (1 mg of norethindrone acetate per 20 cycle and continuous combined OCs as well as many
micrograms of ethinyl estradiol followed by four pla- of the progestin-only contraceptive options (progestin-
cebo pills and 3 mg of drospirenone per 20 micrograms only pills, DMPA, progestin contraceptive implants, and
of ethinyl estradiol followed by four placebo pills). The levonorgestrel intrauterine system) reduce overall bleed-
drospirenone-containing pill has been shown in a ran- ing days and may achieve amenorrhea in many women
domized trial to reduce the symptoms of premenstrual (45, 56). Clinical trials with the single-rod progestin
syndrome (42), and it has been approved by the U.S. contraceptive implant have demonstrated that the irregu-
Food and Drug Administration for treatment of premen- lar bleeding typical of progestin-only methods occurs in
strual dysphoric disorder and acne. the first 3 months, with amenorrhea resulting in 30% and
Women on cyclic hormonal contraception may exper- 40% of women at 1 year (29, 57). Reductions in blood
ience premenstrual symptoms as well as distressing loss of up to 86% after 3 months and up to 97% after 12
symptoms (including pelvic pain, headaches, breast ten- months of use have been reported with the levonorgestrel
derness, and bloating) in the hormone-free interval (38, intrauterine system (58–61). At 12 months after insertion
43). Extending the usual 21-day cycle of contraceptive of the levonorgestrel intrauterine system, reported rates
pills (41, 44, 45) was shown to reduce pelvic pain and of amenorrhea vary between 20% and 80% (62–65).
headaches while improving overall mood (46). Extended A Cochrane review examined the effectiveness of the
levonorgestrel intrauterine system compared with oral
use of the contraceptive patch (10) and the contracep-
cyclical norethindrone for treatment of heavy menstrual
tive ring (47) affords similar benefits. Such regimens
bleeding (66). The report concluded that the levonor-
are one way to avoid menstrual-related symptoms or to
gestrel intrauterine system is a more effective treatment,
delay menstruation for women who anticipate inconve-
and that women with a levonorgestrel intrauterine system
nient menstrual bleeding during travel or important life are more satisfied and willing to continue with treatment.
events. However, these women do experience more side effects,
A progestin injection (DMPA) or progestin con- such as intermenstrual bleeding and breast tenderness.
traceptive implant would not be ideal for short-term A systematic review and meta-analysis found that both the
induction of amenorrhea because of the unpredictable levonorgestrel intrauterine system and endometrial abla-
bleeding associated with early use. A substantial number tion were associated with similar reductions in menstrual
of women using the levonorgestrel intrauterine system blood loss up to 24 months, and both treatments were
and DMPA will achieve amenorrhea. These methods generally associated with similar improvements in qual-
could be considered for long-term menstrual suppres- ity of life (67). Progestogenic side effects were greater in
sion if immediate amenorrhea is not desired, if there is women using the levonorgestrel intrauterine system, and
a contraindication to an estrogen containing contracep- serious side effects occurred more often in those receiving
tive, or if long-term contraception is desired. surgical intervention (66, 68).
VOL. 115, NO. 1, JANUARY 2010 Practice Bulletin Uses of Hormonal Contraceptives 209
What is the role of hormonal contraceptives Ovarian Cancer
in decreasing cancer risk? A collaborative reanalysis of worldwide data on com-
bined OCs and ovarian cancer involving 45 epide-
Endometrial Cancer miological studies with 23,000 ovarian cancer cases
Strong epidemiological evidence supports a 50% reduc- and 87,000 controls has demonstrated that every use of
tion in the risk of endometrial cancer among women combined OC decreases the risk of ovarian cancer by
who have used combined OCs compared with women 27% (110). The longer the duration of combined OC use,
who have never used combined OCs (86–91). The the greater the risk reduction, amounting to a decrease of
Cancer and Steroid Hormone Study confirmed that both approximately 20% for every 5 years of use. The protec-
short-term (less than 5 years) and long-term (equal to or tive effect has been shown to extend to low-dose pills
greater than 5 years) use of combined OCs resulted in (111). Some have suggested that combined OCs be used
similar reductions in risk (92). Longer durations of use as a form of chemoprotection against ovarian cancer by
were associated with greater decreases in risk to as low women with BRCA gene mutations (112).
as an odds ratio of 0.2 (93, 94). This effect lasts for up
to 20 years (95). Overall deaths from endometrial cancer Colorectal Cancer
were significantly reduced in past OC users (HR 0.2) A meta-analysis of 6 cohort and 14 case–control stud-
(96). Limited data suggest that risk reduction persists ies reported an 18% reduction in the risk of developing
with new formulations and lower dose combined OCs colorectal cancer among OC users. This reduction was
(90). Some studies have found a reduction in endome- greatest for recent use and showed no duration effect
trial cancer regardless of the progestin potency of the (113). The Royal College of General Practitioners’
combined OC (97) whereas others found a greater risk Oral Contraception Study also suggested that current or
reduction in those combined OCs with highest progestin recent, but not past, use of combined OCs conferred a
potency (88, 98). Depot medroxyprogesterone acetate lower risk of colorectal cancer, although none of the find-
shows a similar protective effect on subsequent develop- ings reached statistical significance (114).
ment of endometrial cancer (99, 100).
The levonorgestrel intrauterine system achieves Can hormonal contraceptives prevent or be
concentrations in the endometrium several hundred-fold used to treat ovarian cysts?
higher than achieved with traditional systemic therapy By preventing ovulation, hormonal contraception should
(101). The levonorgestrel intrauterine system is now reduce the findings of follicular and corpus luteal cysts
approved as the progestin component of postmenopausal on ultrasound examination as suggested by the results of
hormone therapy in some countries (102). Accordingly, small case series reports (115). Such cysts are rarely of
investigators have examined its use for medical treat- clinical significance although they may lead to unneces-
ment of endometrial hyperplasia (103–105). A systematic sary repeat ultrasound studies when discovered incident-
review found the levonorgestrel intrauterine system to ally. Not all follicular activity is suppressed with low-dose
be an effective treatment for hyperplasia without atypia OCs, and small ovarian cysts are common in users of
(regression in 96%) (106). However, accurate diagno- these formulations (7–9). Case–control studies have failed to
sis and ongoing surveillance are essential. For women demonstrate a difference in the rate of detection of func-
with hyperplasia with atypia, data on the effect of the tional ovarian cysts in women using either monophasic or
levonorgestrel intrauterine system are limited to small triphasic combined OCs (116).
case series. Therefore, it is unclear whether the levonor- The follicle-stimulating hormone-induced suppres-
gestrel intrauterine system is effective for treatment of sion of hormonal contraceptives would seem to be an
atypical hyperplasia. All investigators have emphasized ideal way to accelerate the spontaneous regression of
the importance of continuing endometrial surveillance larger functional ovarian cysts. However, available
to detect cases where atypical hyperplasia persists or research does not support this notion. In a series of RCTs
progresses. Reports of endometrial cancer developing in women of reproductive age, the use of combined
despite use of the levonorgestrel intrauterine system OCs did not hasten the resolution of functional ovarian
suggest the need for caution with this approach (107). cysts compared with expectant management (117–120).
Endometrial sampling can never ensure that the most Therefore combined OCs should not be used to treat
advanced disease is identified, and the risk of missed existing functional ovarian cysts.
endometrial adenocarcinoma is significant (108). The Older studies demonstrated that asymptomatic unrup-
levonorgestrel intrauterine system also has been shown tured follicular cysts may occur in 10–20% of cycles
to protect the endometrium in women taking tamoxifen in women using progestin-only pills (121). Users of
for adjuvant breast cancer therapy (109). progestin contraceptive implants, although anovulatory,
VOL. 115, NO. 1, JANUARY 2010 Practice Bulletin Uses of Hormonal Contraceptives 211
Combined OCs have been shown to regulate and 8. Young RL, Snabes MC, Frank ML, Reilly M. A ran-
domized, double-blind, placebo-controlled comparison
reduce menstrual bleeding, treat dysmenorrhea,
of the impact of low-dose and triphasic oral contracep-
reduce premenstrual dysphoric disorder symptoms, tives on follicular development. Am J Obstet Gynecol
and ameliorate acne. 1992;167:678–82. (Level I)
Continuous combined hormonal contraception, 9. Grimes DA, Godwin AJ, Rubin A, Smith JA, Lacarra M.
DMPA, and the levonorgestrel intrauterine system Ovulation and follicular development associated with
three low-dose oral contraceptives: a randomized con-
may be considered for long-term menstrual suppres-
trolled trial. Obstet Gynecol 1994;83:29–34. (Level I)
sion.
10. Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL,
Fisher AC, Friedman AJ. Extended use of transdermal
The following recommendations are based on lim- norelgestromin/ethinyl estradiol: a randomized trial.
ited or inconsistent scientific evidence (Level B): Obstet Gynecol 2005;105:1389–96. (Level I)
11. LaGuardia KD, Fisher AC, Bainbridge JD, LoCoco JM,
Based on the limited data available it appears over-
Friedman AJ. Suppression of estrogen-withdrawal head-
all that combined OCs do not increase the risk of ache with extended transdermal contraception. Fertil Steril
development of uterine leiomyomas. 2005;83:1875–7. (Level 1)
Hormonal contraception should be considered for 12. White T, Jain JK, Stanczyk FZ. Effect of oral versus
the treatment of menorrhagia in women who may transdermal steroidal contraceptives on androgenic mark-
ers. Am J Obstet Gynecol 2005;192:2055–9. (Level I)
desire further pregnancies.
13. Milsom I, Lete I, Bjertnaes A, Rokstad K, Lindh I,
Gruber CJ, et al. Effects on cycle control and bodyweight
of the combined contraceptive ring, NuvaRing, versus an
Proposed Performance oral contraceptive containing 30 microg ethinyl estradiol
Measure and 3 mg drospirenone. Hum Reprod 2006;21:2304–11.
(Level I)
Percentage of women using hormonal contraception for 14. Roumen FJ. The contraceptive vaginal ring compared with
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15. Meirik O, Fraser IS, d’Arcangues C. Implantable contra-
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VOL. 115, NO. 1, JANUARY 2010 Practice Bulletin Uses of Hormonal Contraceptives 217
Copyright January 2010 by the American College of Obstet-
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American College of Obstetricians and Gynecologists’ publication may be reproduced, stored in a retrieval system,
own internal resources and documents were used to con- posted on the Internet, or transmitted, in any form or by any
duct a literature search to locate relevant articles published means, electronic, mechanical, photocopying, recording, or
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sia and scientific conferences were not considered adequate
for inclusion in this document. Guidelines published by The American College of Obstetricians and Gynecologists
organizations or institutions such as the National Institutes 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920
of Health and the American College of Obstetricians and
Gynecologists were reviewed, and additional studies were Noncontraceptive uses of hormonal contraceptives. Practice Bulletin
located by reviewing bibliographies of identified articles. No. 110. American College of Obstetricians and Gynecologists. Obstet
Gynecol 2010;115:206–18.
When reliable research was not available, expert opinions
from obstetrician–gynecologists were used.
Studies were reviewed and evaluated for quality according
to the method outlined by the U.S. Preventive Services
Task Force:
I Evidence obtained from at least one properly
designed randomized controlled trial.
II-1 Evidence obtained from well-designed controlled
trials without randomization.
II-2 Evidence obtained from well-designed cohort or
case–control analytic studies, preferably from more
than one center or research group.
II-3 Evidence obtained from multiple time series with or
without the intervention. Dramatic results in uncon-
trolled experiments also could be regarded as this
type of evidence.
III Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert
committees.
Based on the highest level of evidence found in the data,
recommendations are provided and graded according to the
following categories:
Level A—Recommendations are based on good and con-
sistent scientific evidence.
Level B—Recommendations are based on limited or incon-
sistent scientific evidence.
Level C—Recommendations are based primarily on con-
sensus and expert opinion.