Gracial ProdMonograph_cover - epgonline.org

Acceptability
Effect of Gracial
on irregular
bleeding
Irregular bleeding
One of the objectives during the development of Gracial was
to minimise irregular bleeding. In a large-scale, European
multicenter study during which 882 women were followed
during a total of more than 12,000 cycles (Dieben et al
1991), excellent cycle control was noted. During Gracial use,
the overall incidence of breakthrough bleeding and/or spotting
decreased from 15.4% in the first cycle to 4% at the end of
the study period.
Subsequent detailed analysis of the study data (Dieben, Op
ten Berg et al 1994) demonstrated that during Gracial use the
incidence of breakthrough bleeding and/or spotting in
switchers decreased from 14.2% in cycle 1 to 8.1% in cycle 6
and to 5.7% by the end of the study period. Table 3 shows
the incidence of spotting and breakthrough bleeding in
switchers during Gracial use.
Table 3: Incidence of irregular bleeding (%) in women
using Gracial (switchers)
Switchers
Cycle S B S/B
1 6.8 6.0 1.4
3 4.4 4.9 0.3
6 4.2 3.6 0.3
12 3.5 2.2 0.0
(S=Spotting B=Breakthrough bleeding) Dieben, Op ten Berg et al 1994
The low incidence of irregular bleeding was associated with a
correspondingly low overall dropout rate of 2.2% after 18
cycles, as a result of irregular bleeding.
Withdrawal bleeding
Overall, withdrawal bleeding failed to occur in only 3.2% of
the 12,850 cycles evaluated in the European multicenter
study (Dieben et al 1991).
Withdrawal bleeding occurred in 92.4% in cycle 1, 95% in
cycle 3, 96.8% in cycle 6 and 98.2% in cycle 18 (Figure 9). In
90% of the women, withdrawal bleeding started within the
first four days of the tablet-free period.
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