A multicentre study with the low dose pill

Sub-title
AuthorsY Muscat Baron
M P Brincat
D Felice
R Galea
AbstractSince the early 60s the side effects of oral contraceptives were noted to be related to the high doses of ethinyloestradiol employed (50 micrograms ethnyloestradiol). The more serious side-effects of note were arterial and venous thromboses with their attendant risk for embolism. Minor side-effects include nausea, headaches, intermenstrual bleeding and weight gain. Over the years research has focussed on reducing the dose of both oestrogen and progestin components in an effort to reduce these side-effects. Whilst reducing the dose of both components the contraceptive efficacy has to be maintained so as to retain a satisfactory Pearl index. These requirements appear to have been attained with the production of the low dose pill 24 day regimen containing 15 micrograms of ethinyloestradiol and 60 micrograms of gestedone. This combination was tried in an open label non-comparative multicentre study performed in five countries of including Malta. Contraceptive efficiency of the 24-day regimen indicated a Pearl index of 0.214 with three pregnancies resulting out of 1,424 women completing 18,223 cycles. The common denominator for contraceptive failure was voluntary or involuntary interruption of pill taking. Another open labelled multicentre study comparing the low dose 24 day ethinyloestradiol 15/gestodene 60 regimem to the 21 day ethinyloestradiol 20/desogestrel 75 regimen was also undertaken. Five hundred and thirty-nine women were recruited with a total 2,982 cycles. One woman fell pregnant after having missed five pills giving a pearl index of 0.242. Minor side effects such as intermenstrual bleeding, headaches, nausea and breast pain were the commonest causes for pill discontinuation The most prominent side-effect was breakthrough bleeding which initially effected 38% of woman recruited. By the 18th cycle only 10% of women complained of intermenstrual bleeding. In conclusion the 24 day regimen of 15 micrograms ethynlestradiol and 60 micrograms gestodene offers the lowest dose and contraception available on the market. The low dose pill promises to reduce contraceptive related side-effects encouraging better compliance and as corollary retaining a satisfactorily Pearl index.

Published in:
JournalMalta Medical Journal
VolumeVolume 15 (suppl)
Pages -
Date
Link to journal

Key wordslow dose pill, oral contraceptive, side effects, Pearl Index

Compiled by: Dr. I. Stabile    Dr. J. Pace