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Received 14 February 2002; received in revised form 23 April 2002; accepted 24 April 2002
Abstract
Emergency contraception was introduced in Nigeria over two decades ago, but few women have used this method even in emergency
situations because of the side effects. To find an acceptable levonorgestrel regimen for emergency contraception in our community, the
two-dose regimen 0.75-mg levonorgestrel 12 h apart (group A) and the single dose 1.5-mg levonorgestrel (group B) were studied in 1118
volunteers. Mild side effects such as nausea, vomiting, lower abdominal pains, menorrhagia, dizziness, headache, and breast tenderness were
reported. Significantly more women in the high-dose group reported headache, breast tenderness, and heavy menstrual flow. Eleven
pregnancies (1.0%) were reported (7 in group A and 4 in group B). The crude relative risk of pregnancies was similar in the two groups
(RR ⫽ 9.71, 95% CI ⫽ 0.32–1.55; p ⬎ 0.05). On the other hand, the estimated effectiveness rate of 86.80% in group A was significantly
lower than the 92.99% for group B (p ⬍ 0.05). The pregnancy rates increased with delay in starting treatment and if further acts of
unprotected sexual intercourse took place after treatment. It was concluded that both regimens were effective and safe. © 2002 Elsevier
Science Inc. All rights reserved.
0010-7824/02/$ – see front matter © 2002 Elsevier Science Inc. All rights reserved.
PII: S 0 0 1 0 - 7 8 2 4 ( 0 2 ) 0 0 3 3 7 - 2
270 A.O. Arowojolu et al. / Contraception 66 (2002) 269 –273
result of fear and accompanying side effects. This limits the Table 1
efficacy of the regimens. Admission characteristics of the subjects in each group
Recently, we noticed that a few of our clients would take Characteristics Levonorgestrel Levonorgestrel
the two levonorgestrel doses at once without major adverse regimen A group regimen B group
effects or accidental pregnancies. Therefore, we designed a (n ⫽ 545) (n ⫽ 573)
prospective study to compare the efficacy and safety of the Mean age ⫾ SD (yrs) 27.4 ⫾ 7.0 26.6 ⫾ 7.2
standard regimen of levonorgestrel pills (i.e., 1.5 mg in two Mean body mass index ⫾ SD 26.1 ⫾ 3.5 25.8 ⫾ 3.7
split doses taken 12 h apart) with 1.5 mg levonorgestrel (kg/m2)
Mean menstrual cycle length ⫾ SD 28.8 ⫾ 2.6 28.5 ⫾ 2.7
taken once for emergency contraception. This article pre-
(days)
sents our findings. History of ⱖ1 previous pregnancy 66.1% 59.3%
Use of emergency contraception 39.4% 34.9%
Table 2 and delayed (⬎7 days after expected menses) for 18%.
Side effects reported by women who gave complete information in each Areas of significant differences are shown on Table 3.
group
Table 4
Comparative estimated effectiveness rates of Groups A and B regimens
Levonorgestrel Regimen A
⫺7 70 0 Observed pregs 7 7 7 7 7
⫺6 29 0 (var) 6.71 6.71 6.71 6.71 6.71
⫺5 30 0 Expected pregs 56.15 65.80 43.99 61.49 53.05
⫺4 32 0 (var) 58.60 69.22 30.45 31.40 26.76
⫺3 44 0 Effectiveness rate 87.53% 89.36% 84.09% 88.62% 86.80%
⫺2 50 0 (var) 0.00242 0.00173 0.00386 0.00188 0.00255
⫺1 57 0 Lower 95% limit 73.00% 77.11% 65.78% 75.98% 72.07%
0 61 2 Upper 95% limit 94.24% 95.06% 92.60% 94.61% 93.77%
1 54 3
2 32 1
3 35 1
4 51 0
Total 545 7
Levonorgestrel Regimen B
⫺7 73 0
⫺6 32 0
⫺5 35 0 Observed pregs 4 4 4 4 4
⫺4 39 0 (var) 3.88 3.88 3.88 3.88 3.88
⫺3 48 0 Expected pregs 60.55 68.31 47.16 65.20 57.05
⫺2 53 0 (var) 66.70 71.46 33.05 34.19 30.02
⫺1 63 0 Effectiveness rate 93.39% 94.14% 91.52% 93.87% 92.99%
0 54 2 (var) 0.00114 0.00088 0.00185 0.00094 0.00124
1 65 1 Lower 95% limit 82.03% 84.16% 77.07% 83.63% 81.25%
2 35 1 Upper 95% limit 97.57% 97.84% 96.86% 97.70% 97.38%
3 35 0
4 40 0
Total 573 4
terms of effectiveness rate, which is more relevant in as- cies following intercourse outside the fertile period is to be
sessing the effectiveness of emergency contraceptives [20]. expected. Our low pregnancy rates with the two regimens
This result may be different if those women lost to fol- are comparable with the rates quoted for levonorgestrel
low-up became pregnant and were considered. For example, trials in studies elsewhere [13,22,23]. The variables that
if no pregnancy occurred among the 15 women who were were likely to affect the pregnancy rates in this study in-
withdrawn from analysis in group A and at least 5 pregnan- clude the distribution of the timing of intercourse with
cies occurred among those withdrawn in group B, the result respect to ovulation among the participants, the proportion
would not be significant. Other examples of extreme cases of women in the less fertile age groups, and the proportion
with a reversal of the effect are no pregnancy among the 15 that had unprotected sexual intercourse as opposed to failure
women lost to follow-up in group A and at least 12 preg- of the barrier method being used.
nancies or at most 27 pregnancies among those lost to Side effects from the contraceptives are very likely to
follow-up in group B. Conversely, in the best-case scenario affect their acceptability by users. The group B women who
(i.e., no pregnancy in all those lost to follow-up), the result took a larger dose of levonorgestrel at once suffered from
would be identical to our findings. headaches, breast tenderness, and menorrhagia more than
The earlier either levonorgestrel regimen was given fol- those in group A. These side effects are features of proges-
lowing sexual intercourse, the greater its efficacy. This terone-only contraception that are dose-dependent and are,
influence of timing of treatment on the efficacy of emer- therefore, not surprising. The side effects encountered in
gency contraceptives has been reported in studies elsewhere both groups were similar to those reported in the WHO trial
[22]. As in the WHO study [22], an inverse relationship in 1998 [13] and have been shown to be unrelated to the
between the efficacy of treatment regimens and the time of number of levonorgestrel tablets taken but varied markedly
treatment following unprotected sexual intercourse was between regions. It seems that strength of a single dose of
seen in the present study. The clustering of pregnancies levonorgestrel tablets has influence on some of the side
around predicted ovulation validates the concept of concep- effects and individual reactions to the regimens are quite
tion probabilities in this study. In view of the biologic important. However, it is reassuring that the side effects
variability in cycle length and the need to rely on calculated encountered in this study were minimal and did not have a
estimates of the day of ovulation, the occasional pregnan- lasting effect on the individuals. Thus, they are unlikely to
A.O. Arowojolu et al. / Contraception 66 (2002) 269 –273 273
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