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Low-dose levonorgestrel-releasing IUD highly
effective over 5 years
The Skyla levonorgestrel-releasing intrauterine system has been found to be highly effective over 5 years.
KRISTINA
GEMZELL-DANIELSSON
"
Intrauterine
contraception
is underutilised,
and many
young women
suffer from
anaemia and
low iron levels.
Intrauterine
systems exert
a positive
impact by
reducing
bleeding and
improving
haemoglobin
levels.
K
ristina Gemzell-Danielsson, MD, of the Karolin-
ska Institutet, Stockholm, Sweden, explained
that she and colleagues set out in this ran-
domised, open-label, phase 3 study to assess
the 5-year efficacy and safety of Skyla levonorg-
estrel-releasing intrauterine system according to
patients’ age, parity, and body mass index.
“This was a development project to bring a new
intrauterine system to market,” said Dr Gemzell-Dan-
ielsson. “The goal of the International Committee for
Contraceptive Research at the Population Council,
of which I am a member, is to develop new safe
and effective contraceptive methods to improve
reproductive health.
“One of the most effective methods born within
the committee is Mirena, a 52-mg levonorgestrel-
releasing intrauterine system. Yet a smaller device
with an even lower hormonal content was needed.”
Women aged 18–35 years with regular menstrual
cycles (21–35 days) who requested contraception
were recruited. The full analysis set included 1452
women (mean age 27.1 years; 39.5% nulliparous;
mean body mass index 25.3 kg/m
2
). The 5-year
Pearl Index score was 0.29.
Unadjusted 5-year Pearl Index scores were 0.18
(0.04–0.54) versus 0.36 (0.17–0.66) for women age
18–25 versus 26–35 years; 0.24 (0.07–0.63) ver-
sus 0.32 (0.15–0.61) for nulliparous versus parous
women, and 0.24 (0.11–0.64) versus 0.56 (0.13–1.42)
for women with body mass index <30 vs ≥30 kg/m
2
.
The 5-year Kaplan-Meier cumulative failure rate was
1.4%. This rate was 1.2% versus 1.6% in nulliparous
versus parous women, 0.9% vs 1.8% in women aged
18–25 versus 26–35 years, and 1.3% versus 2.2%
in women with body mass index <30 vs ≥30 kg/m
2
,
respectively. Only 250 women had a body mass
index ≥30 kg/m
2
, so conclusions on contraceptive
efficacy according to body mass index could not
be drawn.
Risk of partial/complete expulsion was low regard-
less of patient age, parity, or body mass index.
Cumulative 5-year expulsion rates were 3.7% for
both age groups, 1.8% versus 5.0% for nulliparous
vs parous women, and 3.1% versus 6.9% in women
with body mass index <30 versus ≥30 kg/m
2
.
The cumulative 5-year ectopic pregnancy rate was
0.18 per 100 woman-years (0.14–0.28 across all
subgroups). Over 5 years, 328 (22.6%) women dis-
continued due to any adverse event. This rate was
24.2% versus 21.5% in nulliparous versus parous
women. Overall, the most frequent adverse events
that led to discontinuation were vaginal haemor-
rhage (3.5%), system expulsion (3.0%) and pelvic
pain (3.0%).
Dr Gemzell-Danielsson concluded that the Skyla
levonorgestrel-releasing intrauterine system was
highly effective over 5 years, regardless of age or
parity. The system was associated with low rates
of expulsion and ectopic pregnancy. Overlapping
95% confidence intervals for all groups suggested
no major differences between them. Skyla offers
women a lower-dose 5-year contraceptive option.
Dr Gemzell-Danielsson said, “We have shown that
a smaller intrauterine system results in less pain at
placement. Pain at insertion is one of the major bar-
riers to increased use of intrauterine contraception.
Many women prefer non- or low-dose hormonal
methods and local methods.”
She added, “Intrauterine contraception with a lev-
onorgestrel-releasing device is one of the most
effective contraceptive methods available. It is
safe, reduces bleeding, and confers several positive
health benefits. This smaller, lower-dose device,
combined several positive features, is easier to
insert than larger devices, and is effective for the
same 5-year duration. Intrauterine contraception,
with the highest user satisfaction, is cost-effective
and exerts low environmental impact.”
“The World Health Organisation, International Fed-
eration of Gynecology and Obstetrics, and other
agencies recognise that increased use of intrau-
terine contraception (belonging to the long-acting,
reversible contraceptive class) will result in reduced
maternal mortality and morbidity. This class, with
its safety, high efficacy, and high user satisfaction,
will reduce unplanned, unwanted pregnancy and
unsafe abortions.”
Finally, she said, “The goal of these agencies is to
broaden the use of intrauterine systems in general,
and specifically, to a younger age group. Intrau-
terine contraception is underutilised, and many
young women suffer from anaemia and low iron
levels. Intrauterine systems exert a positive impact
by reducing bleeding and improving haemoglobin
levels.”
CONTRACEPTION
Elsevier Conference Series
• ASRM 2016
14