J. Kasule et al., A CLINICAL-TRIAL OF EXLUTON, A PROGESTOGEN ONLY CONTRACEPTIVE PILL CONTAINING 0.5MG LYNESTRENOL AMONGST LACTATING ZIMBABWEAN WOMEN, British journal of family planning, 21(2), 1995, pp. 64-67
A study was carried out to evaluate the overall acceptability an effic
acy of Exluton (0.5mg lynestrenol) amongst healthy lactating women in
Zimbabwe. Two hundred women in the postpartum period were recruited fo
llowing informed consent from Harare Maternity Hospital and followed u
p over 12 months. The main outcome measures were sociodemographic data
, weight gain, infant growth, menstrual bleeding patterns, blood press
ure, various side effects, breastfeeding and pill continuation rates.
One hundred and nineteen women (60 per cent) provided data up to compl
etion, allowing 1556 trial cycles. No pregnancies were reported during
use of Exluton (Pearl Index 0.0, Confidence Interval 0.0-2.3). Up to
45 per cent of the women reported that they had no previous contracept
ive use experience. Efficacy as well as acceptability were high. There
were no adverse effects observed in the women on follow up and their
infants registered normal growth. A slight decrease in weight was obse
rved and no changes in blood pressure were observed. Cycle disturbance
s remained minimal and reasons for premature discontinuation were most
ly non-medical. Incidence of headache reported by 12 per cent at cycle
1 decreased to one per cent in cycles 7 to 12. Thus Exluton provides
an efficacious and safe contraceptive method for women who are breastf
eeding.