Gracial ProdMonograph_cover - epgonline.org

4. Contraceptive
efficacy
• The Pearl Index of Gracial is 0.0 for method failure and
0.1 for user failure, confirming that Gracial is a very
reliable Pill
Pearl Index
Contraceptive reliability can be expressed by means of the
Pearl Index, which is an indication of the number of
pregnancies likely to occur per 100 women per year during
use of the method. Combined OCs belong to the group of
contraceptives with the lowest Pearl Index of any reversible
method of contraception: the Pearl Index of modern low-dose
OCs is usually in the range of 0.1–1.
The Pearl Index can be differentiated into the Pearl Index for
‘user failure’ (including those pregnancies occurring when the
Pill is incorrectly taken, e.g. in the case of forgotten tablets,
vomiting, diarrhea, simultaneous use of interacting drugs) and
for ‘method failure’ (pregnancies occurring when the Pill has
been taken correctly).
In a large-scale, multicenter study of Gracial in which 12,850
cycles were evaluated (Table 2) (Dieben et al 1991) only one
pregnancy occurred and this was attributed to a missed Pill.
This gives a Pearl Index of 0.0 for method failure and 0.1 for
user failure.
Table 2: Pearl Index of Gracial
Pregnancies
Total investigated
cycles Method failure User failure
12,850 0 1
Pearl Index 0.0 0.1
Dieben et al 1991
The Pearl Index for Gracial is fully comparable with that of
conventional low-dose monophasic OCs.
Conclusion
The Pearl Index obtained confirms that Gracial is a very
reliable Pill.
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