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inside
The oral
contraceptive pill
Recent
developments in
delivery systems
Case studies

The author

DR PATRICIA MOORE,
head, family planning unit,
Austin Health, Heidelberg; and
gynaecologist at the centre for
adolescent health, Royal
Childrens Hospital, Parkville,
Victoria.

Recent developments
in CONTRACEPTION
Background
IT is timely to review the recent
developments in contraceptive
options available in Australia. Several new products have become available. These have focused either on
the development of new delivery systems, for example, the vaginal ring,
or altering the pill-free interval in the
case of some of the newer combined
oral contraceptive pills (COCPs).
Alternative delivery systems offer the

possibility of lower oestrogen doses.

This is achieved by better systemic
absorption. Decreasing the pill-free
interval has implications for dose levels
and compliance issues as well as possible non-contraceptive benefits.
Further, a general shift in extending
the indications for options such as
the levonorgestrel-releasing intrauterine system to, for example, nulliparous women, and extending the
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prescription of low-dose COCPs

toward menopause has had a significant impact.
Compliance challenges, such as
correct pill start if delayed from the
time of medical consultation, and
decreased efficacy of typical pill use
compared with optimal use, can be
addressed by introducing the quickstart technique. Decreasing the pillcontd next page
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HOW TO TREAT Recent developments in contraception

from previous page

free interval has similar advantages.

This can be done either with new
brand packaging or by manipulating existing systems to decrease the
placebo interval.
All moves to increase the
patients options and allow tailoring for the individual provide benefits to both patients and practitioners. Getting it right for the
individual is one of the most
important factors in long-term
method use.
GPs are often in a very good
position to counsel appropriately
when they have knowledge of the
patients medical history and social

situation. However, many issues

are very complex and particularly
an initial first contraceptive request
ideally requires longer than the
allotted consultation time. Efficacy
and discontinuation rates are
improved if consult and method
start are concurrent and if early
follow-up is available.
This article aims to provide GPs
with easily accessible resources
with which to optimise contraceptive counselling and answer patient
enquiries. Awareness of, and
screening for, contraindications to
certain methods has been made
easier by recent web-based databases. These resources will enable

evidence-based recommendations
to inform patient choice.

Table 1: WHO ranking of risks of serious side effects occurring

with different contraceptive methods*

World Health Organization

guidelines

WHO 1: A condition for which there is no restriction for the use of the
contraceptive method (eg, asthma and a COCP)

Since 1996 the WHO has published

Medical Eligibility Criteria for Contraceptive Use. This document summarises the recommendations of an
expert working party who analysed
available evidence. It is reviewed
regularly and represents a highly
accessible up-to-date evidence-based
review. New methods are rapidly
reviewed. The document ranks the
risks of serious side effects occurring with each method as shown in
table 1.

WHO 2: A condition in which the advantages of using the method outweigh

disadvantages/risks (eg, a smoker aged <35 using a COCP)
WHO 3: A condition in which the theoretical or proven risk generally
outweighs advantages of the method (eg, previous DVT and a COCP)
WHO 4: A condition that represents an unacceptable risk if the method is
used (eg, COCP and focal migraine)
*WHO Medical Eligibility Criteria for Contraceptive Use: www.who.int/
reproductive-health/publications/mec; WHO Selected Practice Guidelines for
Contraceptive Use: www.who.int/reproductive-health/publications/spr/

The oral contraceptive pill

THROUGHOUT the 1970s
and 1980s, most research
and development was
geared towards reducing the
oestrogen component of the
pill. The emphasis then
shifted towards decreasing
the androgenic effects of the
progestogen component.
The 1990s saw the development of third-generation
progestogens. Structural
modifications to the subunits reduced androgenic
activity
further
and
improved blood lipid profiles. Some research indicated some third-generation
agents increased the thromobembolic phenomena.
Most recently a nonsteroidal
progestogen,
drospirenone, has been made
available, initially with a 30g
oestrogen
component
(Yasmin) and now with a
20g 24-active-day/four-dayplacebo pack (Yaz). The nonsteroidal
progestogens
appear to have a better
weight-gain profile due to
their antimineralocorticoid
action and a favourable lipid
profile.
Yaz has an anti-androgenic action and is therefore
indicated for acne. This
COCP has also been listed
for use for premenstrual dysphoric disorder. It is not PBS
subsidised. Break-through
bleeding rates are comparable to those with 30g
oestrogen regimens.
The last 5-8 years have
seen more development
towards reducing the overall oestrogenic component
while making the pill more
user-friendly. In Australia the
combined oestrogen and
progesterone pill is the most
commonly used reversible
method of contraception,
but is also very poorly
adhered to. A study by
Rosenberg et al. reported
19% of pill users consistently missed one or more
1
pills per cycle. A substantial
proportion of women with
unplanned pregnancies
report current pill usage (3040%).

Altering placebo interval

A recent change that has
occurred has been to decrease the pill-free interval.

26

| Australian Doctor | 3 April 2009

The quick-start technique

Described by Westoff, this refers to starting the COCP on the day of the consultation, either late
in the menstrual cycle or immediately after emergency contraception rather than recommending
2
the patient wait till the next menses
This is unlicensed use but often entirely appropriate for selected patient use
Suggests greater possibility of future compliance
First
Ascertain low pregnancy risk, ie, apply WHO practice guidelines one or more of the following
to apply:
no intercourse since last normal menstrual period
correct use of other method
within seven days of onset of menses
within seven days of miscarriage or termination of pregnancy
fully or nearly fully breastfeeding less than six months postpartum
after emergency contraception
Second
Obtain negative urine pregnancy test
Third
Begin in active section of packet in the office
Seven days added condom use mandatory
Early follow-up for all with repeat pregnancy test
Written and verbal information on the method supplied

Seven days of placebo pills

was always an arbitrary
figure based on marketing
research from the 1960s
and 1970s. Seven days represents the average number
of days before spontaneous
ovulation would occur.
However, occasional spontaneous ovulation will
occur, as witnessed by the
small but significant
number of women who
report COCP method failure with ideal use.
By reducing the pill-free

interval, the theoretical

number of spontaneous ovulations can be expected to
decrease and thus the impact
of non-ideal, or typical, pill
use. Various preparations
have been marketed in
Europe and the US in which
active tablets are taken for
84 days followed by a sevenday pill-free interval. Thus
there are four scheduled
bleeds a year.
These preparations are
costly and really just replicate
the already established off-

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licence use of skipping

placebo pills that many practitioners have shown their
patients. These brands have
maintained a 30g oestrogen
dose and are associated with
significant episodes of
unscheduled or break-through
bleeding.
Running packets of a
monophasic COCP together
without placebo can usually
be maintained for around 23 months without breakthrough bleeding by most
women. Not only does the
impact of missed pills lessen
but the technique confers
some non-contraceptive
benefits such as decreased
menstrual loss and dysmenorrhoea. There is mounting
evidence of a suppressive
effect on surgically excised
endometriosis.
Many
women report a lessening of
premenstrual syndrome and
premenstrual dysphoria but
there is no confirmatory
research for this as yet.
As previously mentioned,
the COCP Yaz decreases the
oestrogen dose further to
20g by extending the active
tablets to 24 per cycle, with
four placebo tablets. By
decreasing the pill-free interval the daily dose of oestrogen can be lowered without
increasing spontaneous ovulation rates.
Positive implications for
decreasing the pill-free interval include:
Decreasing the oestrogen
dose while maintaining
anovulation.
Decreasing the impact of
missed pills.
Decreasing symptoms experienced by many women in
the pill-free interval, eg,
headache, premenstrual syndrome, premenstrual dysphoria.
Extension of COCP use
beyond previously established age limits towards
menopause in the otherwisewell low-risk patient.
Alleviating some perimenopausal symptoms in
the pill-free interval such as
poor sleep and hot flushes.
Regular, light scheduled
bleeds and less unscheduled
bleeding than with tricycling of previously available products.

Improving method uptake

and adherence
The quick-start technique

It has been shown that if

women need to wait until
the next menstrual period
before starting the COCP
they are less likely to start,
more likely to express dissatisfaction with the method
and more likely to have
method errors.
Family planning authorities are now advocating wide
consideration of starting a
method at the time of the
consultation as a way of
increasing adherence and
understanding of the
method, as the patient does
not have to retain information they are not practising.
Westoff described the
method in 2002 (see box,
left) and showed that
women who swallowed the
first tablet from a contraceptive prescription during the
consultation were three
times more likely to continue
the prescription beyond the
2
first month. They were also
less likely to report dissatisfaction with the method.
Further, the self-reported
unplanned pregnancy rates
were lower at six months.
The quick-start technique
can be extended to use with
other methods such as the
vaginal ring or patch. Note
that the use of the quickstart technique is off-licence
use.

Contraception and the

older woman
General recommendations
for perimenopausal contraceptive use are continued use
for two years after menopause if the woman is under
50, and one year if over 50.
Previous wisdom had indicated that women should
stop the COCP in their early
40s. This left many women
with fewer easily available
methods requiring little
effort at the time of intercourse. While fecundity may
decline in the late 30s and
40s, a womans career and
family commitments do not,
making ease of method a
major consideration for
many.
Smokers or women with
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other cardiovascular risk factors should always discontinue COCP use by age 35
(WHO 4, table 1). At age 50
the risks of COCP use are
deemed greater than the
advantages (WHO 3).

Healthy, migraine-free,
non-obese women in their
40s
It is now felt that the contraceptive and non-contraceptive
benefits outweigh the small,
though increased, cardiovascular or breast cancer risks.
For example, the protective
effects of the COCP against
ovarian and endometrial
cancer are enhanced with
length of pill use.
However, other choices may
be more appropriate, such as
the levonorgestrel-releasing
intrauterine system (Mirena) or
partner vasectomy. Consider
using the lower-dose 20g
oestrogen preparations, particularly a 24/4 regimen, for those
experiencing adverse or perimenopausal symptoms in the
pill-free interval. HRT requires
backup contraception in the
perimenopause, and the combined action of the COCP may
be the most acceptable solution
up to a womans 50th year.

Contraception and the

adolescent patient
Compliance and ease of
method are crucial here.
Discontinuation rates for
the COCP are higher in
under-25-year-olds. The
skin patch as an alternative
(requiring only once-weekly
application) has not been
shown to increase compliance and is more often
reported as unacceptable in
younger women. The threeyearly etonogestrel implant
(Implanon) offers instant
adherence but again is more
often reported as unacceptable in young women. The
main reasons cited are menstrual irregularity and mood
disturbance.
As is the case with older
women, there is a considerable minority of young
women with medical or psychological contraindications

Contraceptive advice and prescription in minors

Definition of a minor in Australia
In all states and territories a person below the age of 18 is considered to be a minor.
In NSW specific legislation protects medical practitioners from being sued for assault and battery
for providing medical treatment to a young person aged 14 and over if the young person has
consented to treatment.
In SA specific legislation allows for those aged 16 and over to provide consent. Those aged
under 16 can consent to treatment if and when two medical practitioners believe and state in
writing the treatment is in the best interest of the child and the child is capable of understanding
the nature, consequences and risks involved.
Victoria, Queensland, Tasmania, WA, ACT and NT do not have specific legislation covering a
young persons capacity to give consent.
Note: Common law allows for the mature minor assessment regardless of state or territory.
In essence this means that for oral, injectable or implantable hormones it is legal in all Australian
states and territories for contraceptive advice and prescription to be given to a minor without
parental consent or notification, if the young person is deemed competent by their doctor, and the
young person does not want their parent informed.
Test of competency (also known as the Gillick test)
Established by the English House of Lords in the Gillick ruling and approved by the High Court of
Australia in Marions case
The case established that:
The authority of parents with respect to a young person of less than 18 years is limited,
controlled and varying. It is limited to what is in the interests of the welfare of the young person,
and
A minor has capacity to give consent where they possess sufficient intellectual capacity and
emotional maturity to understand the nature and consequences of the procedure or treatment
proposed.
Note there is no lower age limit.
The assessing doctor must consider within the consultation:
Age
Level of independence
Schooling obtained
Maturity
Ability to articulate wishes and request
Potential for abuse (age of partner and consensual nature of relationship)
Mandatory reporting requirements
You will need to satisfy yourself by enquiry that:
The young person understands the method, mode, efficacy and side effects
They understand the consequences for them of treatment and non-treatment, ie, potential
unwanted pregnancy
They understand the consequences of discovery of treatment by parents/guardian
They intend to be sexually active anyway
You regard the advice to be in the patients best interest
Often open-ended questions about the young persons perception of parental response to
contraception, sexual activity and pregnancy are helpful in establishing their level of maturity and
competence.
If you remain unsure whether a young person is competent, seek the opinion of a colleague.
Documentation
Note the competency assessment in the history, and your conclusion. As stated, there is no lower
age limit; however, the younger patient will require perhaps more specific documentation regarding
independence and maturity.

to the COCP or other methods. Young women with

bleeding disorders or who
require anticoagulation and
those who are nulliparous
may derive greater benefit
from the levonorgestrelreleasing intrauterine system
without long-term adverse
fertility outcomes.

Women with disabilities

For women with intellectual
and physical disabilities who
may require both menstrual
management and contraception, greater options are
now afforded them and their
carers. Reversible long-term
methods of contraception
such as Implanon or Mirena

Quick counselling guide for the oral contraceptive

pill and cancer
Reduced cancer risk
The risk of some cancers is reduced by COCP use:
Ovarian cancer risk reduced by 50%
Colorectal cancer risk reduced by 18-40%
Endometrial cancer risk reduced by 50%
Increased cancer risk
The risk of cervical cancer is slightly increased by COCP use
(most longitudinal studies estimate 30-125 new cases per
100,000 women after eight years use)
Breast cancer and COCP use
Studies are imperfectly powered and literature has been
conflicting
Best meta-analysis indicates:
current users of COCP: relative risk 1.24
risk declines after use to approach that of never-users by 10
3
years
Counselling: eg, if 10 women per 1000 are expected to have
a diagnosis of breast cancer by age 45, use of the COCP can
4
be attributed to add one more case per 1000
The relative risk is not associated with duration of use or the
dose of oestrogenic or progestogenic elements
No synergism with other risk factors, eg, family history
WHO recommendations in specific conditions:
benign breast disease or family history of breast cancer in
a first-degree relative under 45 (WHO 1)
previous breast biopsy with epithelial atypia (WHO 4)
breast cancer diagnosed less than five years ago (WHO 4)
women developing breast cancer while using the COCP
(WHO 4)
known inherited breast cancer gene mutation (WHO 3)

provide highly effective contraception. Sterilisation and

hysterectomy are special
procedures
requiring
guardianship board ruling.
Mirena efficacy is not
reduced by simultaneous use
of liver enzyme-inducing
medications.
The potential decrease in

first-pass metabolic effects

of the vaginal ring or hormonal patch has not been
conclusively researched as
yet and these methods are
less appropriate in intellectually or physically impaired
patients who might pull off
a patch or be unable to perform vaginal insertion.

Recent developments in delivery systems

The vaginal ring

The NuvaRing is a
54mm ethylene vinyl
acetate ring that
secretes a combination
of ethinyloestradiol and
etonogestrel.

NUVARING was introduced onto

the Australian market in the last two
years but has been available in the
US and Europe for longer than this.
It is in the form of a 54mm ethylene
vinyl acetate ring that secretes a
combination of ethinyloestradiol and
etonogestrel. The mechanism of contraceptive action is threefold. Ovulation is inhibited, cervical mucus
forms a thickened plug, and implantation is prevented by the alteration
in the endometrium. Efficacy with
perfect use is 99%, and 92% with
typical use, as per the COCP.
This represents another option
for easily reversible contraception
for women that does not require
daily dosing. The ring is highly mal-

28

| Australian Doctor | 3 April 2009

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leable and easily inserted inside the

vagina. Unlike the diaphragm it
does not require exact positioning
and is generally not uncomfortable
for either partner during intercourse.
The ring is inserted on day one of
the cycle and retained for three
weeks before removal. One week
later the next ring is inserted. Efficacy is maintained if the ring is
removed, for example, for intercourse (however removal for intercourse is unnecessary and not recommended by the manufacturers)
for up to a maximum of three
hours. Some women prefer not to
insert the ring during menses.
Delayed insertion (ie, if the ringfree interval has been greater than
one week), with one weeks contin-

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uing use of barrier methods

to overlap, is possible. Similarly, the quick-start technique can be employed if the
low-risk conception criteria
are checked and met, as for
the COCP. One study
showed immediate initiation
was associated with higher
acceptance of method rates
5
at follow-up.
The vaginal route, with
the benefit of greater absorption than oral administration, has afforded an opportunity to further lower the
dose of oestrogen to 15g
daily while still causing
anovulation. Advantages are
therefore incurred for
women with oestrogen side
effects and older women
wishing to continue their
contraceptive cover at the
lowest possible exposure
level. The possible benefits
of avoiding first-pass metabolism, such as lessening
interactions with enzymeinducing drugs, has not been
proven in research trials as
yet.
The WHO working group
on Contraceptives and Medical Eligibility Criteria have
stated that until further
research becomes available
the vaginal ring should be
regarded as the same as the
oral contraceptive pill with
regard to suitability for use
in women with other medical conditions.
The most common specific
side effects in vaginal ring
users include vaginosis and
irritation, increase in vaginal
discharge, headache, weight
gain and nausea. Sinusitis
and URTI are also listed in
the product information.
The rate of breakthrough
bleeding appears to be similar to that of the 30g
oestrogen-containing COCP.
Expulsion of the device
can occur, for example, with
intercourse or tampon
removal, with a three-hour
window for return. The
device need only be rinsed
before reinsertion. Expulsion
rates are likely to be higher
in chronic constipation, obesity and a degree of
uterovaginal prolapse.
The ring is not covered by
PBS funding, resulting in
costs between 60 cents and
one dollar per day.
NuvaRing is an example
of the interaction of new
technologies. The company
offers to text message
women a reminder to
change rings. A how to
insert video is easily accessible on YouTube.

The contraceptive patch

Again this is a product that is
widely used in Europe and
the US. However, the device
is not yet available in Australia and the cost here is
expected to be high. This is a
transdermal delivery system
for ethinyloestradiol and
progesterone. Once-a-week
application may prove to be
an advantage for women
who find daily compliance a

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series in young and nulliparous women.

Implanon overall has a
lesser incidence of hypooestrogenism than depot
injection of medroxyprogesterone acetate (Depo-Provera)
and is less likely to affect
bone density long term. This
has resulted in increased use
in patients when osteopenia
is a potential risk.

Lasting five years, the Mirena

intrauterine system provides
reversible contraception with
99% efficacy.

Implanon

Recent changes and their evidence base

Level of evidence
Intrauterine systems
Intrauterine systems are safe in appropriately
selected nulliparous and young women

Level III

COCP
Increasing the active pill/placebo ratio:
Increases efficacy
Increases compliance
Can enable lower oestrogen doses

Level I
Level II-2
Level I

Safe to extend COCP towards menopause

Level I

After 50 years, method risk > pregnancy risk

Level II-2/ Level III

Current pill use results in increased risk of breast cancer

(relative risk 1.24) this declines to zero 10 years after stopping use

Level I

Quick-start technique
Safe
May improve compliance

Level I
Level I

New delivery systems

Vaginal ring, patch, 24/4 COCP preparations:
Allow for decreased oestrogen dose without compromising
efficacy
Desirous for women with oestrogenic side effects
and in older women
Increasing indications for safe use of
progesterone implant:
Perimenopausal contraception
Endometrial protection in hyperplasia risk
Menstrual management in intellectually or
physically disabled patients

Level I
Level II-1

Level II-2
Level II-2
Level III

Hysteroscopic sterilisation:
Safe, less invasive
Possible outpatient procedure
Efficacy profile appears to exceed that of
laparoscopic techniques

Level III
Level III
Level III

problem. A new patch is

applied each week for three
weeks, followed by a patchfree week. The start method
is the same as for the COCP,
with the ability to use the
quick-start technique if eligibility criteria are met.
The mechanism of contraception is as for the COCP
and vaginal ring, that is, inhibition of ovulation, thickening
of cervical mucus and prevention of implantation. Again the
oestradiol dose is lower, conferring advantage. First-pass
metabolism is avoided but, as
stated previously, the implications of this are not as yet fully
researched.
Efficacy is quoted as equivalent to that of the COCP.
However, later studies regarding pregnancy rates and discontinuation rates suggest as
low as 90% efficacy for typical
use. Efficacy may be less in

women weighing >90kg.

The patch may adhere
incorrectly on some skin types
and, as with HRT transdermal
preparations, local reactions
are relatively common. Visibility of the method is another
common negative feedback.
WHO eligibility for use criteria remain for the moment
the same as for the COCP.

Progesterone implants
Both the subdermal and
intrauterine progesterone
implants have been available for some time. Both
are PBS listed and thus provide very affordable longterm reversible contraception with excellent efficacy
rates.
Indications for their use
continue to broaden as
experience is gained. Use of
Mirena has now been successfully reported in several

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An etonogestrel implant is a
progesterone-only implant
designed for subdermal use
in the non-dominant arm.
Daily release of hormone
continues for three years.
The insertion requires training and it is considered a
procedure for GP medical
indemnity insurance purposes. These two factors
have possibly deterred GPs
from using this method, and
wait-time for family planning clinic referral may
result in non-start of the
method. The mechanism of
action is threefold: preventing ovulation, preventing
implantation, and thickening
the cervical mucus.
A very significant advantage of this method is that,
after insertion is confirmed,
efficacy of perfect and typical use converges at 99.9%.
It is rapidly reversible and
requires minimal patient
effort. A purse-size reminder
card is issued at insertion. It
represents a good alternative
for women with contraindications to oestrogen, or who
have an inflammatory bowel
disorder or another malabsorption condition.
All women using the
implant experience some
menstrual disturbance, varying from amenorrhoea to
frequent disruptive unscheduled bleeding. There is little
risk of movement of the
device, and removal is only
difficult if initial insertion
was too deep. This situation
has decreased since the company addressed it in training
sessions. Similarly, after
product release in Australia
a series of pregnancies
resulted from inadvertent
non-insertion due to operator error. It is essential that
both clinician and patient
can palpate the device after
insertion.
Contraindications include:
Breast cancer diagnosed
within the past five years.
Current DVT/pulmonary
embolism.
Undiagnosed PV bleeding.
Active viral liver disease
(WHO 4).
Concurrent use of liverenzyme-inducing drugs
(WHO 3).
Reported side effects
include irregular bleeding,
weight gain, acne and mood
disturbances. Data on longterm (>3 year) use and bone
mineral density are reassuring at this point. The device
is safe in breastfeeding. Discontinuation rates sit at
25% at six months, with the

most common reasons cited

being bleeding and mood
disturbance.
Nevertheless this remains
a good option for many with
adherence challenges who
are willing to trade increased
unscheduled bleeding for a
very safe method. The early
return to fertility after
removal is reassuring for the
patient, and for the clinician
weighing risks and benefits.
When ideally inserted on
days 1-5 of the cycle for
immediate efficacy, uptake is
likely to be reduced. Again,
the quick-start technique is
possible if additional methods
are employed for seven days
after inserting in a patient in
whom risk of pregnancy has
been assessed as low.
Levonorgestrel-releasing
intrauterine system

Lasting five years, this device

provides long-term reversible
contraception with 99% efficacy. Therefore many women
opt to continue to use the
method on into menopause.
The mode of contraceptive
action is thickening of cervical mucus and, secondarily,
endometrial atrophy. A small
minority of women will
become anovulatory, especially in the first year.
Current evidence points to
the ability to extend years of
safe usage in older women.
If women are 45 or older,
one insertion only may suffice, continuing the device
for one year after last
menses. The system can provide progestogenic support
with HRT.
Non-contraceptive benefits include endometrial
protection in conditions
known to cause chronic
anovulation and therefore
potential
endometrial
hyperplasia. Therefore a
patient with polycystic
ovary syndrome will benefit
from contraception plus
endometrial protection
without potential oestrogenic adverse effects.
Decrease in menstrual loss
is consistently about 95%
and this has major implications for use in women with
menorrhagia, iron deficiency
and indeed bleeding disorders
or concurrent anticoagulation. It is also a good option
for women over 40 with risk
factors such as smoking,
hypertension, obesity or in
whom oestrogen side effects
are best avoided. In the obese
patient the method represents
better efficacy than, for
example, the patch, and is
less likely to be expelled than
the vaginal ring.
As previously mentioned,
increased experience with
the device has shown the
method to be safe to extend
to nulliparous and young
women without compromising their future fertility. The
overall incidence of PID
remains the same for users
and non-users, with a peak
increase in the first 20 days
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Hysteroscopic sterilisation

after insertion. It is therefore necessary to screen for STIs in all women

counselled for Mirena insertion. Long
term, the mode of action, with
increased cervical mucus, may provide a barrier against ascending infection. A current episode of PID
remains WHO category 4, while a
past history of PID is WHO 2.
The retention rate of this method is
greater than that of all other
reversible methods. This combined
with high efficacy has seen a steady
rate of increasing uptake since its
introduction.

Of the several existing methods of hysteroscopic tubal occlusion, the Essure

method is the only one available in
Australia. This method has the advantage of being non-hormonal and not
requiring laparoscopy, with its attendant potential risks.
The device is a 4cm stainless steel
core with polyethylene terephthalate
fibres wrapped around it, which
encourage fibrosis, with tubal occlusion
occurring in three months. Around this
is a nickel-titanium alloy coil. The
device is hysteroscopically placed into
the ostia with a single-handed hystero-

scopic control mechanism. This has

been reworked recently to improve ease
on insertion. The insertion can be performed under local anaesthetic as an
outpatient procedure; overall cost savings to the patient and health system
can therefore result.
At this point the device is not PBS
listed, incurring considerable expense
for the patient. Since its release in 2002,
cumulative failure rates are 0.1%,
which is 10 times better than for laparoscopic sterilisation. A steep learning
curve is experienced by operators which
has, together with cost, led to a slower
than anticipated uptake in Australia.

Authors case studies

16-year-old girl
SASHA is 16 and attends the
clinic worried about possible pregnancy. She had surgical termination of pregnancy
at an early gestation about
six months ago. After this
she did not start the COCP
as planned, as her relationship broke up. A recent
episode of unprotected intercourse resulted in her using
the morning-after pill three
days ago, some 18 hours
after intercourse.
A menstrual history
reveals a regular cycle, with
her last period being three
weeks ago. Her periods are
heavy with flooding, interfering with her basketball
training on several occasions
this year.
Sasha has a past history of
anxiety for which she saw a
school counsellor but was
not medicated. She reports a
low mood since she and her
boyfriend split up and has
difficulty sleeping at times.
She goes out with friends
most weekends, drinking
upwards of five drinks each
session. The episode of
unprotected intercourse
occurred after one such
drinking binge. In the past
she has used condoms, but
not for the last episode.
She lives with her mother,
who knows about the termination of pregnancy and was
supportive at the time. She
feels her mother regards her
as too young to be having sex
and would disapprove of the
pill.
Issues

Sasha is 16 and is regarded

as a minor. She demonstrates
competency in terms of
understanding of the methods of contraception and the
situation she is in. She is not
in a relationship, is not being
coerced and has a supportive
relationship with her mother.
You encourage her to talk to
her mother about contraception. You deem it appropriate to provide information
and prescription as indicated.
Sasha screens positive for
depressive/anxiety symptoms
and is binge drinking. This
increases the incidence of
other risk-taking such as
unprotected intercourse and
other substance abuse. You

30

| Australian Doctor | 3 April 2009

explore the possibility of

depression further and she
denies other major symptoms, including suicidal
thoughts. You refer her to
her school counsellor and
recommend a review
appointment. Depressive
symptoms may be a contraindication to progestogens
such as Implanon.
After a negative pregnancy
test Sasha would be eligible for
COCP quick start (see box,
page 26). After discussion she
is keen to trial the COCP. You
suggest Microgynon 30, initially to be taken cyclically
and, if tolerated, skipping the
placebo pills on alternate
months in an effort to alleviate
her menorrhagia. Her menstrual symptoms warrant at
least an FBC and iron studies
(and, if abnormal, proceeding
to a coagulation screen and
thyroid function tests).
You co-ordinate follow-up
in 7-10 days. Sasha needs a
follow-up pregnancy test and
STI screening. You should also
check her HPV vaccine status
and discuss Pap smear timing.

Depressive
symptoms
may be a
contraindication
to progestogens
such as
Implanon.

Helen, 38, comes to see

you regarding sterilisation.
A divorcee, she has two
children aged eight and
seven years and does not
want any more children.
She has recently started a
new relationship with a
man her age who has no
children. Initially she
thought about taking the
pill but thinks she may be
too old. The couple are
currently using condoms
but she feels they ruin
spontaneity.
Helen is otherwise well
and is a non-smoker. Her
periods are becoming
increasingly heavy and she
gets a 1-2-day headache
around the end of her
period most months.
Issues

Outcome

Sasha starts Microgynon 30

in the office that day and
returns for a pregnancy test
and STI screen the next
week, which are negative.
She decided to tell her
mother, who was relieved
she would not be dealing
with another unplanned
pregnancy. Sasha has made
an appointment with the
same counsellor as before.
Her blood work is within
normal limits. You revise the
method and in particular the
missed-pill routine. She
decides to run two packs
together.
At three-month follow-up

A woman in her 30s

Sasha returns happy with the

method and its effect on her
periods. She reports no side
effects, has not been sexually active and has forgotten
two pills only, both in the
middle of packets. She
reports her mood is better
and she has attended fortnightly appointments with
the counsellor, which she is
finding helpful. She continues to drink heavily on occasions but denies any other
substance use. She now carries condoms in her bag.

Helen obviously requires

reliable contraception. If
the relationship becomes
serious this may see a
change in the desire of the
couple for children. A barrier method would provide
protection until monogamy
is certain, STIs are screened
for and a long-term
method established.
Helens history reveals
possible non-contraceptive
benefits from some methods. A tubal ligation or
hysteroscopic occlusion
would provide non-reversal reliable contraception
but severely impact on
options later. Neither
method addresses her menstrual symptoms.
Helen is not too old for
the COCP, as she is otherwise at low risk for cardiovascular disease. An agent
such as Yaz, with a 24/4
preparation, decreases

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placebo exposure and may

relieve both menstrual loss
and her headaches if they
are due to oestrogen fluctuations. Similarly a
NuvaRing offering an even
lower oestrogen dose may
be acceptable.
A Mirena also offers
good menstrual control
with highly effective contraception.
As Helen is under 45 she
could expect to require at
least one change of device to
ensure premenopausal cover.
An Implanon offers a
good reversible long-term
option but no certainty
around menstrual pattern.
Outcome

After discussion of the risks

and benefits Helen opts for
Yaz, which she uses with
good effect for menstrual
management and headaches. She remains happy
with the method but
returns after six months
because her 46-year-old
sister has developed breast
cancer.
Helen has no other relatives with the disease and
no personal risk factors.
You explain that her sisters
diagnosis raises her relative
risk of breast cancer slightly
to 1.4, compared with a
relative risk of 1.24 as a
current COCP user. You
explain that the two risk
factors are not additive.
Mirena is offered as an
option and Helen proceeds
to have this inserted. She
remains happy with this
method, reports amenorrhoea and manages occasional headaches symptomatically. The couple elect
to have no further children.
contd page 32

References
1. Rosenberg MJ, et al. Use
and misuse of oral
contraceptives: risk
indicators for poor pill
taking and discontinuation.
Contraception 1995;
51:283-88.
2. Westoff C, et al. Quick
start: a novel oral
contraceptive initiation
method. Contraception
2002; 66:141-45.
3. Kahlenborn C, et al. Oral
contraceptive use as a risk
factor for premenopausal
breast cancer: a metaanalysis. Mayo Clinic
Proceedings 2006; 81:12901302.
4. Guillebaud J.
Contraception Today.
London: Informa
Healthcare, 2007.
5. Schafer J, et al.
Acceptability and
satisfaction using Quick
Start with the contraceptive
vaginal ring versus an oral
contraceptive.
Contraception 2006;
73:488-92.

Further reading
Contraception: an
Australian Clinical
Practice Handbook.
Canberra: Sexual Health
and Family Planning
Australia, 2006.
Amory JK. Contraceptive
developments for men.
Drugs Today 2007;
43:179-92.
Zurawin RK, et al.
Innovations in
contraception: a review.
Clinical Obstetrics and
Gynaecology 2007;
50:425-39.

Online resources
WHO Medical Eligibility
Criteria for Contraceptive
Use: www.who.int/
reproductivehealth/publications/mec/
WHO Selected Practice
Guidelines for
Contraceptive Use:
www.who.int/reproductive
-health/publications/spr/

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HOW TO TREAT Recent developments in contraception

GPs contribution

DR HEA-WON PARK
West Ryde, NSW

Case study
SAMANTHA, 31, had her
first baby nine months ago.
She recently returned to work
after weaning her daughter
from breastfeeding. She presented wanting to start the
oral contraceptive pill. She is a
non-smoker with no risk factors for venous thromboembolism.
Before her pregnancy she
had been taking a COCP
(Juliet-35 ED), with no significant adverse effects. Her
menarche was at age 13 and
she has had regular periods
with a cycle length of 28-30

days. Her premenstrual mood

changes can be significant,
with irritability and depressed
mood. She also wanted to discuss options for weight loss,
as she had considerable
weight gain during her pregnancy. In the past four months
she suffered from an acne-like
rash on her chin, which had
not responded to any overthe-counter creams.
Samanthas mother had
breast cancer diagnosed at age
40. There are no other members in her family with either
breast or ovarian cancer.
On examination, Samantha
was overweight, with a BMI
2
of 29kg/m . Her blood pressure was 140/79mmHg. She
had mild perioral dermatitis
on her chin and nasolabial
folds.
On discussing various
COCP options, Samantha
was prescribed Yaz to see if it
would be effective in relieving

her premenstrual dysphoria

and to minimise possible
weight gain. She asked to try a
topical therapy before taking
oral antibiotics for her perioral dermatitis.
At review two months later
she had not noticed a significant improvement in her
mood, found the cost of Yaz
prohibitive and decided to go
back to using Juliet-35 ED.
Her perioral dermatitis had
improved markedly.
Towards the end of the consulation, she mentioned that
she had noticed some rightsided breast changes over the

How to Treat Quiz

Recent developments in contraception
3 April 2009
1. Which TWO statements about the WHO
ranking of side effects of contraceptive
methods are correct?
a) WHO 1 is a condition that represents an
unacceptable risk if the contraceptive
method is used
b) WHO 2 is a condition in which the
advantages of using the method outweigh
the disadvantages/risks
c) WHO 3 is a condition in which the
theoretical or proven risks generally
outweigh the advantages of the method
d) WHO 4 is a condition for which there is no
restriction for the use of the method

technique of using the COCP are correct?

a) Running packets together without placebo
can usually be maintained for about 2-3
months without breakthrough bleeding in
most women
b) This technique of using the COCP may
lessen the impact of missed pills
c) There is no evidence that this technique of
using the COCP is beneficial in women with
endometriosis
d) There is good evidence to support a
reduction in premenstrual syndrome and
premenstrual dysphoria with this technique
of using the COCP

2. Which TWO statements about the

combined oral contraceptive pill (COCP) are
correct?
a) In Australia the COCP is the most
commonly used reversible method of
contraception
b) Research has shown that about one-fifth of
pill users consistently miss one or more pills
per cycle
c) Up to 10% of women with unplanned
pregnancies report current pill use
d) COCPs containing non-steroidal
progestogens have a less favourable lipid
profile and are associated with greater
weight gain

4. Which THREE statements about

contraceptive use in older and young
women are correct?
a) At age 50 the risks of COCP use are
deemed greater than the advantages
b) The protective effects of the COCP against
ovarian and endometrial cancer are
enhanced with length of pill use
c) Discontinuation rates for the COCP are
higher in under-25-year-olds
d) The skin patch and the etonogestrel implant
have been shown to be very acceptable
alternatives to the COCP in young women

3. Judy, 24, is taking a monophasic COCP

containing 30g oestrogen. She
experiences non-migrainous headaches for
1-2 days during her period most months.
She asks you if she can run several packets
of the pill together by skipping the placebo
pills so she only has a period every three
months. Which TWO statements about this

5. Which TWO statements about the quickstart technique of initiating the COCP are
correct?
a) Westoff showed that women who started
the first contraceptive pill during the
consultation were three times more likely to
continue the prescription beyond the first
month
b) Westoff showed that women who started
the first contraceptive pill during the

last few weeks. On examination there was some diffuse

thickening and nodularity in
the right breast just medial to
the areola. The area was nontender and axillary lymph
nodes were not enlarged.
A breast ultrasound (
mammogram) and fine needle
aspiration biopsy were
arranged and Samantha was
to return in one week to
review the results. In the
meantime she was asked to
stop the COCP and use barrier contraception.

Questions for the author

Samantha was asked to stop
her COCP while her breast
symptoms were being investigated. Is this an appropriate
precaution to take?
No, it is better to wait for a
definitive diagnosis to be
made before ceasing a medication that may not be implicated. The risk:benefit analysis

of unwanted pregnancy at this

time needs to be addressed.
How effective is Yaz at reducing symptoms of premenstrual
dysphoric disorder and in
what time frame should these
effects be apparent?
There is some evidence that
Yaz may provide relief in premenstrual dysphoria conferring greater benefit than
placebo in a blinded study.
Taking the pill continuously is
more likely to alleviate symptoms and should be trialled
for at least three months prior
to scheduling a bleed. Yaz is
also listed for use in premenstrual dysphoric disorder
being the only COCP in this
category at present. Anecdotal evidence suggests that
many women receive benefit
by tricycling their pill usage
and having fewer scheduled
bleeds. This would be a less
costly option.

Other options for this

woman might include use of a
Mirena device which may
confer benefit from premenstrual syndrome. This is
poorly understood, but has
been reported. One possibility is that some women
become anovulatory on
Mirena. Attention to lifestyle
issues such as exercise and rest
may also confer relief.
Recourse to antidepressants in
the second half of the cycle
has also been demonstrated to
have a positive effect on premenstrual syndrome.
Does drospirenone in Yaz
have positive effects on perioral dermatitis (same as with
acne)?
Yes, this may well be the
case. Again, most oestrogendominant COCPs will show
improvement which may be
sustained after discontinuation
of the method.

INSTRUCTIONS
Complete this quiz online and fill in the GP evaluation form to earn 2 CPD or PDP points. We no longer accept quizzes
by post or fax.
The mark required to obtain points is 80%. Please note that some questions have more than one correct answer.

ONLINE ONLY
www.australiandoctor.com.au/cpd/ for immediate feedback
consultation were less likely to report
dissatisfaction with the method
c) Westoff showed that among women who
started the first contraceptive pill during the
consultation, unplanned pregnancy rates
were higher at six months
d) Quick start is a licensed method of using
the COCP
6. Which TWO statements about the vaginal
(ethinyloestradiol and etonogestrel) ring are
correct?
a) Efficacy rates with the vaginal ring are lower
than with the COCP
b) Greater absorption via the vaginal than the
oral route has enabled the dose of
oestrogen in the ring to be lowered to 15g
daily
c) Efficacy after expulsion or removal of the ring
is maintained for a maximum of three hours
d) The rate of break-through bleeding with the
vaginal ring is twice that of the 30g
oestrogen-containing COCP
7. Which TWO statements about the
contraceptive patch are correct?
a) Studies suggest that the efficacy of the
contraceptive patch may be as low as 90%
for typical use
b) Efficacy of the contraceptive patch may be
less in women weighing >90kg
c) There are proven benefits to the avoidance
of first-pass metabolism with the
contraceptive patch
d) Local reactions to the contraceptive patch
are uncommon
8. Which TWO statements about the
etonogestrel implant are correct?

a) Efficacy of the etonongestrel implant is

99.9%
b) It is essential that both clinician and patient
can palpate the etonongestrel implant after
insertion
c) The etonongestrel implant is contraindicated
in women who are breastfeeding
d) The reversibility of the etonongestrel implant
is poor
9. Which TWO statements about the
levonorgestrel-releasing intrauterine system
are correct?
a) The levonorgestrel-releasing intrauterine
system provides contraception for three
years with 95% efficacy
b) The levonorgestrel-releasing intrauterine
system may be helpful in women with
menorrhagia
c) The levonorgestrel-releasing intrauterine
system cannot be used as the
progestogenic component of HRT
d) All women counselled for insertion of a
levonorgestrel-releasing intrauterine system
should be screened for STIs
10. Which TWO statements about the
Essure method of hysteroscopic tubal
occlusion are correct?
a) The Essure method is a less invasive
procedure than laparoscopic sterilisation
b) The Essure procedure requires a general
anaesthetic
c) The procedure involves placement of a device
in the fallopian tubes, which encourages
fibrosis, resulting in tubal occlusion
d) Failure rates with the Essure procedure are
higher than those with laparoscopic
sterilisation

CPD QUIZ UPDATE

The RACGP now requires that a brief GP evaluation form be completed with every quiz to obtain category 2 CPD or PDP points for the 2008-10 triennium. You
can complete this online along with the quiz at www.australiandoctor.com.au. Because this is a requirement, we are no longer able to accept the quiz by post
or fax. However, we have included the quiz questions here for those who like to prepare the answers before completing the quiz online.

HOW TO TREAT Editor: Dr Wendy Morgan

Co-ordinator: Julian McAllan
Quiz: Dr Wendy Morgan

NEXT WEEK Despite a consistent decline in cardiovascular death rates since the 1970s, cardiovascular diseases remain the leading cause of death and disability in Australia. Prevention therefore remains
a major national priority. The next How to Treat presents the latest on identifying and estimating cardiovascular risk in asymptomatic patients who have not yet developed overt cardiovascular disease. The
authors are Dr Anushka Patel, cardiologist and director, cardiovascular division, The George Institute for International Health, Camperdown; Dr David Peiris, general practitioner and senior research fellow,
The George Institute for International Health, Camperdown; and Dr Patrick Groenestein, cardiologist and senior research fellow, The George Institute for International Health, Camperdown, NSW.

32

| Australian Doctor | 3 April 2009

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