A phase III clinical study was carried out among 534 fertile Latin American
women to evaluate cycle control, side effects, and contraceptive efficacy
of a once-a-month combined injectable, Mesigyna, consisting of 50 mg noreth
isterone enanthate and 5 mg estradiol valerate. The pregnancy rate at 1 yea
r was 0 per 100 woman-years for a total experience of 4688 woman-months. Th
e overall discontinuation rate at one year was 17.9%. Discontinuation rate
for bleeding problems was 5.2%. The Colombian women had a significant incre
ase (p <0.001) in bleeding problems compared to other countries. The discon
tinuation rate for amenorrhea was 1.1%. There were no significant differenc
es between the groups regarding discontinuation for other medical or non-me
dical reasons. Mean weight gain after one year of use was 1.02 kg. Mesigyna
is an appropriate once-a-month injectable contraceptive for Latin American
women since it is highly effective and its perception of normal menstrual
bleeding is of importance in the Latin American population. (C) 2000 Elsevi
er Science Inc. All rights reserved.