The European Journal of Contraception and Reproductive Health Care, February 2010;15:416

Efficacy of contraceptive methods:

A review of the literature
Diana Mansour*, Pirjo Inki{ and Kristina Gemzell-Danielsson{
*Newcastle Sexual Health Services, New Croft Centre, Newcastle upon Tyne, UK, {Bayer Schering Pharma AG,
Berlin, Germany, and {Department of Woman and Child Health, Division of Obstetrics and Gynaecology, Karolinska
Eur J Contracept Reprod Health Care Downloaded from informahealthcare.com by Universitat de Girona on 12/16/14

Institutet (WHO Centre), Stockholm, Sweden

...........................................................................................................................................................................................................

ABSTRACT Objectives To provide a comprehensive and objective summary of contraceptive failure

rates for a variety of methods based on a systematic review of the literature.
Methods Medline and Embase were searched using the Ovid interface from January 1990
to February 2008, as well as the reference lists of published articles, to identify studies
reporting contraceptive efficacy as a Pearl Index or life-table estimate. Reports that recruited
less than 400 subjects per study group and those covering less than six cycles/six months were
excluded. In addition, unlicensed products or those not internationally available, emergency
contraception, and vasectomy studies were excluded.
Results Information was identified and extracted from 139 studies. One-year Pearl Indices
For personal use only.

reported for short-acting user-dependent hormonal methods were generally less than 2.5.
Gross life-table rates for long-acting hormonal methods (implants and the levonorgestrel
releasing-intrauterine system [LNG-IUS]) generally ranged between 00.6 per 100 at one
year, but wider ranges (0.11.5 per 100) were observed for the copper intrauterine devices
(0.11.4 per 100 for Cu-IUDs with surface area 300 mm2 and 0.61.5 per 100 for those
with surface area 5300 mm2). Barrier and natural methods were the least effective.
Conclusions Our review broadly confirms the hierarchy of contraceptive effectiveness in
descending order as: (1) female sterilisation, long-acting hormonal contraceptives (LNG-IUS
and implants); (2) Cu-IUDs with 300 mm2 surface area; (3) Cu-IUDs with 5300 mm2
surface area and short-acting hormonal contraceptives (injectables, oral contraceptives, the
patch and vaginal ring), and (4) barrier methods and natural methods.

KEYWORDS Contraception; Efficacy; Pearl Index; Life-table

...........................................................................................................................................................................................................

INTRODUCTION

Womens contraceptive choices are often based on contraception in a manner that is comprehensible is
advice from healthcare providers, family, partners and/ crucial for informed choice3. Women need to know
or friends1. Effectiveness is usually mentioned as the which factors affect contraceptive effectiveness (e.g.,
single most important reason for choosing a contra- compliance), and those that may limit the usefulness of
ceptive2. Therefore, communicating effectiveness of the method (e.g., use during special circumstances like
the various methods to the lay person who needs breast-feeding).

Correspondence: Dr Diana Mansour, Newcastle Sexual Health Services, New Croft Centre, New Croft House, Market Street (East), Newcastle upon
Tyne NE1 6ND, UK. Tel: 44 (0)191 229 2862. Fax: 44 (0)191 229 2976. E-mail: Diana.Mansour@newcastle-pct.nhs.uk

2010 European Society of Contraception and Reproductive Health

DOI: 10.3109/13625180903427675
 A review of contraceptive failure rates
Surprisingly few studies have been performed
regarding the different strategies of communicating
this information2. In general, communication of
contraceptive effectiveness in categories (more effec-
tive, effective, less effective) rather than absolute
numbers was found to be more helpful in the correct
interpretation of the available data by lay people3.
However, without absolute numbers, many women
grossly overestimate the absolute risk of pregnancy
during the use of contraceptives. Therefore, both
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categories, and a general efficacy range of risk, may
lead to more precise understanding of contraceptive
effectiveness2.
The aim of this paper is to provide a compre-
hensive and objective summary of contraceptive
failure rates for a variety of methods, based on a
systematic review of the literature for commonly
used fertility control methods over the entire
duration of follow-up reported. In addition, data
obtained from controlled clinical trials and post-
marketing (observational) studies will be presented,
providing the readers with both perfect use and
For personal use only.
typical use efficacy rates. This review is intended
to complement the widely cited summary of
contraceptive efficacy for various methods published
by Trussell, which is largely based on US-specific
data and describes failure rates for the first year of
use only4. We excluded retrospective database
studies and national survey data from our review,
and focused only on studies from 1990 onwards so
as to increase data homogeneity and to ensure that
the evidence is based on clinical studies governed by
good clinical practice guidance.
METHODS
Online databases, Medline and Embase, were searched
using the Ovid interface from January 1990 to
February 2008 for publications reporting contracep-
tive failure rates. A combination of MeSH and free
text terms relevant to contraception were used as
follows: contraceptive agents, female OR oral contraceptive
agent OR oral contraception OR contraceptives, oral OR
contraceptives, oral, combined OR pregnancy OR intrau-
terine devices, copper OR Pearl Index OR life table AND
contracep*. The search was limited to English language
articles and excluded reviews (including pooled or
meta-analyses) or studies where the contraceptive
product/method could not be fully differentiated.
The European Journal of Contraception and Reproductive Health Care
Mansour et al.
The reference lists of known primary and review
articles were also examined to identify cited studies
not captured by the electronic search. Publications
with less than 400 subjects and those shorter than six
cycles/six months were excluded so as to be consistent
with the recommendations of international guidelines
for studies on contraceptive effectiveness5. In addition,
unlicensed products or those not internationally
available, emergency contraception, vasectomy stu-
dies, and fertility studies were excluded.
The Pearl Index and life-table techniques provide
two methods of measuring contraceptive failure, and
form the basis of the main outcomes reported in this
review. Studies were selected in a two-stage process.
First, the titles and abstracts from the electronic
searches were scrutinised for articles that reported or
were likely to report contraceptive failure rates either
as a Pearl Index or life-table estimate. Full manuscripts
of all citations that were likely to meet the predefined
selection criteria were obtained and scrutinised for
inclusion in this review. All articles identified as
reporting Pearl Indices or life-table estimates that met
the inclusion criteria were selected and data extracted.
The Pearl Indices were classified as either perfect use
or typical use and the life-table rates were classified as
gross, net or unclear (i.e., not clearly defined in the
original paper). No statistical analyses were performed
on the data collated our aim was to summarise the
ranges of reported efficacy rates by contraceptive
method.
RESULTS
We identified and extracted information from 139
publications (publications assessing more than one
method are only counted once); a detailed description
of each publication is provided in Appendix 1 which
can be accessed from www.informahealthcare.com/
doi/pdf/10.3109/13625180903427675. Of these pub-
lications, 47 assessed combined oral contraceptives
(COCs)652, one assessed progestogen-only pills
(POPs)53, three assessed the patch13,16,54, three assessed
the vaginal ring9,12,55, 15 assessed implants5670, 16
assessed injectables7186, 31 assessed copper intrauterine
devices (Cu-IUDs)33,69,87115, nine assessed the levo-
norgestrel-releasing intrauterine system (LNG-
IUS)97,103,110,112,113,116119, three assessed the male
condom120122 four assessed other barrier meth-
ods123126, 11 assessed natural methods127137, and
5
 A review of contraceptive failure rates
four assessed female sterilisation69,138140. Overall,
there were 64 publications of randomised controlled
studies included in this review.
There was heterogeneity in the reporting of the
womens baseline demographics between studies.
However, mean age ranges for those studies that
reported this parameter were: 2336 years for COC
studies (there was one COC study in adolescents
which reported a mean age of 16 years); 2829 years
for the contraceptive patch; 2728 years for the
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vaginal ring; 2530 years for implants; 2329 years for
injectables; 2535 years for Cu-IUDs; 2735 years for
the LNG-IUS; 2629 years for barrier methods; 27
30 years for natural methods; and 3031 years for
sterilisation. In general, studies recruited mainly
Caucasian women and there was a higher incidence
of nulliparous women recruited to the COC studies in
contrast to those recruited to studies with Cu-IUDs or
the LNG-IUS.
The contraceptive failure rates reported as either
Pearl Indices or life-table rates are summarised in Table
1. In general, Pearl Indices were nearly always reported
For personal use only.
for short-acting user-dependent hormonal methods
(COCs, POPs, the patch and vaginal ring) while life-
table rates were preferred for long-acting contraceptive
methods. There was little difference in the Pearl
Indices reported for all the user-dependent hormonal
methods (first-year Pearl Indices less than 2.5 for both
typical and perfect use). Interestingly, first-year Pearl
Indices reported for oral contraceptives in studies
performed in the USA/North America (range: perfect
0.231.26; typical 0.462.18) were slightly higher than
those obtained elsewhere (range: perfect 00.55;
typical 01.34). In a reanalysis of data from a study
already included in this review, Archer et al. reported
much higher failure rates for an oral contraceptive and
the contraceptive patch (Pearl Indices were 7.58 and
4.46 over the first year, respectively) for imperfect use,
where women did not follow dosing instructions
correctly141. There were too few studies performed in
the USA/North America with long-acting hormonal
methods for a meaningful comparison of failure rates
with studies done elsewhere.
Gross life-table rates for long-acting hormonal
methods (implants and the LNG-IUS) generally
ranged between 00.6 per 100 at one year, but wider
ranges were observed for the Cu-IUDs (0.11.5 per
100). In addition, differences in failure rates were
observed between Cu-IUDs depending on their
6 The European Journal of Contraception and Reproductive Health Care
Mansour et al.
surface area. The one-year gross life-table rates for
Cu-IUD with 300 mm2 surface area (range 0.11.4
per 100) were generally lower than those with a
surface area 5300 mm2 (range 0.61.5 per 100).
Interestingly, the long-acting reversible hormonal
contraceptives (implants and the LNG-IUS) appear to
be at least as effective as female sterilisation over the
first year (Table 1).
Lactational amenorrhoea seems to a have reasonable
efficacy up to six months (failure rate 0.4 to 2.0 per
100 depending on how lactational amenorrhoea was
defined)135137, but failure rates, as expected, are much
higher at 12 months (4.4 to 8.8 per 100). It should be
noted that the continued use of the lactational
amenorrhoea method for contraceptive purposes
beyond six months is not recommended. In general
barrier- and natural contraceptive methods were the
least effective of all the methods reported (Table 1). In
another reanalysis of data from a study already
included in this review Trussell and Grummer-Strawn
reported first-year failure rates for correct and
consistent use for the ovulation method of 3.2% and
85.0% for imperfect use which is similar to the
proportion of women (about 89%) who conceive in
the first year of trying to get pregnant suggesting that
the method was extremely unforgiving with improper
practice142.
DISCUSSION
Our systematic review of the available data support the
hierarchy in descending order of contraceptive effec-
tiveness as: (1) female sterilisation, long-acting hor-
monal contraceptives (LNG-IUS and implants); (2)
Cu-IUDs with 300 mm2 surface area; (3) Cu-IUDs
with 5300 mm2 surface area and short-acting hor-
monal contraceptives (injectables, oral contraceptives,
the patch and vaginal ring); and (4) barrier methods/
natural methods. It is broadly consistent with the data
summarised by Trussell in the US setting4. There are,
however, some notable similarities and differences.
We present both the first-year Pearl Indices and life-
table rates, as well as the longest duration from studies
where data are available. The one-year estimates
summarised in our study enable us to make direct
comparisons with the data presented by Trussell, while
the unrestricted overall summary of failure rates from
eligible studies perhaps better reflects real-life where
women use their chosen methods for many years.
 Eur J Contracept Reprod Health Care Downloaded from informahealthcare.com by Universitat de Girona on 12/16/14
For personal use only.

Table 1 Summary of contraceptive efficacy with various contraceptive methods

1-year Pearl 1-year life-table

Pearl Index (range) Index (range) Life-table (range) (range)
Study Study
duration Gross Net Unclear duration Gross Net Unclear
(months, (per (per (per (months, (per (per (per
A review of contraceptive failure rates

Method Perfect Typical range) Perfect Typical 100) 100) 100) range) 100) 100) 100)

Combined oral 01.26 02.18 636 01.26 02.18 0.22.3 0.11.5 02.6 628 0.22.3* 0.11.33 0.22.6
contraceptive652
20 mg EEx 01.26 01.82 636 01.26 01.6 NA NA 02.6 628 NA NA 02.6
30 mg EEx 00.62 01.19 624 00.55 01.19 NA NA 0.031.385 612 NA NA 0.431.07
Progestogen-only pills53 0.14 0.41 12 0.14 0.41 NA NA NA NA
Patch13,16,54 0.590.99 0.711.24 612 0.590.99 0.711.24 NA NA 0.41.3 612 NA NA 0.41.3
Vaginal ring9,12,55 0.310.96 0.251.23 12 0.310.96 0.251.23 NA NA 0.711.2 12 NA NA 0.711.2
Implants5670 0 00.3 2484 NA 00.08 01.3 00.8 02.32 2484 00.2 0 0

The European Journal of Contraception and Reproductive Health Care

Injectables7186 0 0 12 0 0 0 01.1 0.030.62 1236 0 01.1 0.060.62
Copper IUDs33,69,87115
300mm2 surface NA 0.161.26 4884 0.15.9 06.5 0.42.9# 12144 0.11.4 02.0 0.41.2
5300mm2 surface NA NA 0.68.5 0.57.6 1.74.9 12144 0.61.5 0.50.8
LNG-IUS 7,103,110,112,113,116118 NA 0.090.11 60 0.1 01.1 00.3 00.5 3684 00.6 00.1 00.1
Male condom120122 NA 2.55.9 6 NA NA 1.010.8 6 NA NA
Other barrier method 123126 NA NA 9.8 NA 7.417.7 612 9.8 NA 16.717.7
Natural methods127137 0.73.1 3.820.4 36 3.1 20.4 24 7.027.68 0.438.4 660 24 7.02 2.538.4
Lactational NA NA NA NA 0.48.8 612 NA NA 4.48.8
amenorrhoea135137
Female sterilisation69,138140 NA NA 0.080.69 NA 0.551.85 12120 0.110.69 NA 0.55

*Data shown for 11 months. EE: ethinylestradiol; IUD: intrauterine device; LNG-IUS: levonorgestrel-releasing intrauterine system; NA: not available or not applicable.
x
Monophasic preparations.
#
One study115 reported much higher failure rates at 3 and 5 years for the Nova T (6.6% and 12.3%, respectively) and was discontinued (these data are not included
in the summary ranges presented).

7
Mansour et al.
 A review of contraceptive failure rates
Although the Pearl Index is a simple, convenient
and well-accepted measure of contraceptive failure in
clinical trials, it is seriously limited in that contra-
ceptive failure estimates usually decline with contin-
ued duration of use the reasons for this apparent
decline have been discussed in detail elsewhere143.
Briefly, this is probably due, in part, to the fact that less
effective users are filtered out, and that use generally
improves with practice. The inherent limitation
associated with the Pearl Index is eliminated with
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life-table estimates, resulting in gross and net cumu-
lative failure rates depending whether single or
multiple decrement tables are constructed. Although
gross failure rates are more useful than net rates in that
they allow direct comparisons between studies with
different dropout rates for reasons other than preg-
nancy at a given time point, many of the studies in our
review either reported only net failure rates or did not
specify which rates they reported.
The one-year typical use failure rates reported by
Trussell for user-independent long-acting methods
(i.e., Cu-IUDs, the LNG-IUS, implants) and includ-
For personal use only.
ing female sterilisation, fall within the one-year
cumulative gross ranges reported in Table 14. How-
ever, the typical use failure rate for COCs reported by
Trussell is at least three-fold higher than the upper
range of the one-year cumulative gross rate we report.
This observation is perhaps not surprising since higher
failure rates are generally observed in practice than in
clinical studies: the data for oral contraceptives
(inclusive of POPs) reported by Trussell were based
on the 1995 National Survey of Family Growth while
we reported data from only clinical trials. We
excluded national survey data from our review, and
focused only on studies from 1990 onwards so as to
increase data homogeneity and to ensure that the
evidence is based on clinical studies governed by good
clinical practice guidance. Interestingly, the upper
one-year cumulative gross range for natural methods is
consistent with that reported by Trussell.
We also noted that the one-year failure rates for
Cu-IUD with 300 mm2 surface area were generally
lower than for those with a surface area 5300 mm2.
There were limited or no appropriate data of contra-
ceptive failure rates reported at one year with the
other methods in our review for meaningful compar-
isons with equivalent data reported by Trussell4.
Interestingly, the range of Pearl Index rates at one
year reported for studies with COCs performed in the
8 The European Journal of Contraception and Reproductive Health Care
Mansour et al.
USA/North America was slightly higher than those
reported elsewhere. In addition, higher failure rates
were observed in a US-based study of the vaginal ring
compared with an identical study performed in
Europe the European study55 reported a first-year
Pearl Index of 0.65 but a subsequent analysis which
combined data from both studies (pooled studies were
specifically excluded from our review) reported a first-
year Pearl Index of 1.18,144 implying a much higher
failure rate in the US study. This phenomenon is
generally well recognised, and may, in part, be due to
differences in compliance rates in studies performed in
the USA/North America compared with those
performed elsewhere19,145. Indeed a low overall Pearl
Index of 0.51 (95% CI: 0.470.56) has recently been
reported in a prospective, post-marketing, non-
intervention cohort study of new users of oral
contraceptives under routine conditions of medical
practice in seven European countries, with body mass
index and absolute weight having only minor
influence on contraceptive reliability146. There were
limited data from studies of other contraceptive
methods performed in USA/North America for
meaningful comparisons with those from other
regions, though compliance is unlikely to differ
between regions for long-acting methods as their
consistent and proper use is user-independent.
The range of Pearl Indices reported at one year for
COCs containing 20 mg ethinylestradiol (first-year
Pearl Index; 01.6) were slightly higher than those
reported with 30 mg ethinylestradiol-containing
COCs (first-year Pearl Index; 01.19). However,
there was substantial overlap in the reported Pearl
Indices between the two groups, which suggests that
there would be little difference in effectiveness in
routine clinical practice. It should be noted also that
these studies mainly assessed 28-day cycle (mainly 21/
7) regimens, and it is not clear whether the same
pattern would be observed with extended regimens.
The limited available data with extended COC
regimens in our review, however, do not suggest that
they are more efficacious than the 28-day cycle
regimens. In addition, the data summarised in our
review suggest that there is little difference in efficacy
between COCs and other combined hormonal
formulations such as the patch and vaginal ring.
Only one study with POPs was included in our
review53; this study with a 75 mg desogestrel pill
reported a contraceptive efficacy which was similar to
 A review of contraceptive failure rates
that of COCs. This similarity in contraceptive efficacy
may, in part, like COCs, be attributed to the more
consistent inhibition of ovulation with the 75 mg
desogestrel pill147. Most POPs do not consistently
inhibit ovulation and rely on other contraceptive
effects to prevent pregnancy, and typically have first-
year Pearl Indices higher than those for COCs. In
addition, the 12-hour window of opportunity from
scheduled pill intake with the desogestrel-only pill
without loss of efficacy is more forgiving than the 3
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hours for other POPs148. As such, the desogestrel-only
pill may have greater effectiveness in clinical practice
compared with other POPs.
In the studies assessed, there was a preference for
reporting Pearl Indices for short-acting hormonal
methods (e.g., COCs, POPs, the patch and vaginal
ring) and life-table estimates for long-acting methods
(e.g., Cu-IUDs, the LNG-IUS, implants/injectables
and female sterilisation). This discrepancy in reporting
may be, in part, because the primary efficacy
assessment for supporting approval of new contra-
ceptive products in the USA, specifically oral,
For personal use only.
transdermal and vaginal contraceptive products, is
based on the Pearl Index, although life-table preg-
nancy rates are also reviewed149. The European
Medicines Agency requires that pregnancy rates be
reported using both Pearl Index and life-table analyses
for all pregnancies during treatment with steroid
contraceptives5. However, statistical reasoning would
suggest that one-year contraceptive failure rates
reported using life-table methods may be prefer-
able150. Nonetheless, as failure rates with steroid
contraceptives are usually very low the differences in
calculated failure rates by both methods would be
minimal.
This review of contraceptive efficacy may not
reflect real life. Higher failure rates are generally
observed in practice than in clinical studies. For
example, our data may suggest that the injectable
contraceptives have a first-year failure rate of 1%,
while in practice, the first-year probability of failure of
7% is almost as high as that observed for oral
contraceptives (9%)151. This may, in part, be attributed
to publication bias in favour of studies with low failure
rates, thereby resulting in lower and narrower overall
ranges in our summary of failure rates than would
be expected in practice. In addition, clinical
studies, tend to recruit adults (18 years) while in
practice, contraceptive use and sexual activity start in
The European Journal of Contraception and Reproductive Health Care
Mansour et al.
adolescence. This discrepancy between clinical studies
and practice would in general mainly affect those
methods that require a degree of user compliance. For
example, as younger women tended to opt for COCs
as their method of choice1,152, this would contribute
to higher failure rates in practice than clinical studies
for a variety of reasons including lack of compliance
and higher fecundity153. However, age may be less of
an issue when comparing the failure rates across the
studies summarised in our review because there was
substantial overlap in the mean ages of the women
recruited across the studies assessing the various
methods.
Ethnicity and socioeconomic factors have been
associated with differential risks of failure in practice
for reversible methods that require a degree of user
compliance151. Kost et al. showed that Black women
faced an elevated risk of failure relative to non-
Hispanic Caucasian women, and even more so for
those who lived in poverty and relied on a partner-
dependent method (such as the condom or with-
drawal). Differential failure risk with ethnicity and
socioeconomic factors suggest that differential com-
pliance may be more of an issue, and there would be a
real need for improved counselling or education
provisions with regard to contraception in those
recognised at increased risk of contraceptive failure.
Moreover, financial incentives may be an effective
way to increase compliance with treatment in at-risk
populations and promote attendance of workshops
aimed at health promotion and/or risk reduc-
tion154,155. Nonetheless, the majority of studies
included in our review recruited mainly Caucasians.
The main difference observed was that there was a
higher incidence of nulliparous women recruited
to the COC studies, in general, in contrast to
those recruited to studies with Cu-IUDs or the
LNG-IUS.
Our summary of failure rates associated with various
contraceptive methods should serve as a useful guide
to family planning providers when counselling women
about the likelihood of pregnancy with a given
method in relation to other available options.
Although no contraceptive method is 100% effective,
the long-acting hormonal methods (implants and the
LNG-IUS) provide contraceptive protection over the
first year that is at least comparable with that achieved
by sterilisation. This high reliability is consistent across
both formal clinical studies and in practice. In contrast,
9
 A review of contraceptive failure rates
natural methods have the highest failure rates and
should not be recommended where the resultant
unplanned pregnancy would have a detrimental
impact. Moreover, both highly effective and less
reliable methods can be combined with condom use
Double Dutch to prevent sexually transmitted
infections, and in the case of natural methods, provide
additional protection during the time of highest
pregnancy risk.
In conclusion, our review broadly confirms the
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hierarchy of contraceptive effectiveness in descending
order as: (1) female sterilisation, long-acting hormonal
contraceptives (LNG-IUS and implants); (2) Cu-IUDs
with 300 mm2 surface area; (3) Cu-IUDs with
5300 mm2 surface area and short-acting hormonal
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Declaration of interest: Dr Mansour has received
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