Product Monograph - epgonline.org

Contents
5
Acceptability 19
1
Introduction
5.1 Bleeding pattern 19
Terminology 20
Bleeding patterns in starters and switchers 20
Trends over time 22
Bleeding pattern in breast-feeding women 24
Discontinuation related to changes in bleeding
pattern 25
5.2 Subjective adverse events 26
Dysmenorrhea 27
Acne 27
5.3 Effect on body weight 28
5.4 Follicle enlargement 28
5.5 Discontinuation related to adverse events 29
5.6 Summary 29
6
Use during lactation 31
6.1 Summary 32
7
Safety aspects 35
7.1 Lipid metabolism 35
7.2 Carbohydrate metabolism 37
7.3 Hemostasis 37
7.4 Blood pressure 40
7.5 Liver enzymes 40
7.6 Effects on other physiological systems 40
7.7 Summary 41
8
9
10
Summary 43
References 45
Summary of product characteristics 53
Combined oral
contraceptives
(COCs)
Progestogen-only
pills (POPs)
The most popular form of reversible contraception in use today
is the combined oral contraceptive (COC). However, while COCs
are highly effective, the estrogen component is dose-dependently
associated with a wide range of adverse events that precludes
their use in certain women (Guillebaud 1993). The main
concern with COCs is the demonstrated association with venous
thromboembolism (Gerstman et al. 1991; Helmrich et al. 1987;
Thorogood et al. 1992; Vessey et al. 1986). Furthermore,
although myocardial infarction (MI) and stroke are less common
with today’s low-dose COCs than with earlier formulations
(Carr and Ory 1997; Godsland and Crook 1996; Lidegaard et al.
2002; Rosenberg et al. 1997), there is still a slightly increased
relative risk of MI in smokers over 35 years of age, and of stroke
in women who smoke or who have high blood pressure (Carr and
Ory 1997; Godsland and Crook 1996; Rosenberg et al. 1997).
COCs are therefore unsuitable for women with risk factors for
arterial and venous thrombosis (Alving and Comp 1992;
Guillebaud 1993; Machin et al. 1995).
Even in women with no apparent contraindications, the use of
estrogens may be associated with “nuisance” adverse events,
such as nausea, headache and breast tenderness, which are
important reasons for women to discontinue use of COCs. The
use of estrogens can also adversely affect the quantity and
composition of breast milk in lactating women.
Progestogen-only pills (POPs) are a suitable alternative to COCs.
However, the majority of the currently available POPs also have
some important disadvantages. First, they do not suppress
ovulation consistently, but instead rely largely on their effects on
the cervical mucus for contraceptive activity. This is the reason for
the 3-hour intake window of traditional POPs and their reduced
contraceptive efficacy. Moreover, as progestogens slow transport
of the ovum along the fallopian tubes (McCann and Potter 1994),
POPs are associated with an increased risk of ectopic pregnancy
compared to COCs because they do not consistently inhibit
ovulation. Second, POPs have variable effects on the
endometrium, resulting in an unpredictable vaginal bleeding
pattern, and this often results in their discontinuation. Third, the
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