S. Koetsawang et al., MULTICENTER TRIAL OF 2 MONOPHASIC ORAL-CONTRACEPTIVES CONTAINING 30 MCG ETHINYLESTRADIOL AND EITHER DESOGESTREL OR GESTODENE IN THAI WOMEN, Contraception, 51(4), 1995, pp. 225-229
The efficacy and acceptability of two third generation oral contracept
ives in Thai women were evaluated in a prospective, open, group-compar
ative, randomized, multicenter trial of women asking for contraception
. In six Family planning Centers and Outpatient Gynaecological Clinics
in urban areas in Thailand, 783 healthy women who were at risk for pr
egnancy and did not have contraindications to oral contraceptive use w
ere randomly allocated to one of the two study groups. An oral contrac
eptive containing 30 meg ethinylestradiol and 150 meg desogestrel was
given to 394 women and an oral contraceptive with the same amount of e
thinylestradiol and 75 meg gestodene to 389 women during 6 cycles. Cri
teria of cycle control, side effects and the presence and severity of
acne vulgaris were assessed and blood pressure and body weight measure
d at pretreatment and after cycles 1, 3 and 6. Furthermore, the effica
cy was evaluated after the last cycle. No pregnancies occurred with ei
ther of the contraceptives. The incidences of irregular bleeding and m
inor side effects in both groups were very low and decreased after an
initial increase in the first cycle. Acne improved in both groups. Flo
od pressure and body weight remained unchanged. The two oral contracep
tives were found to be effective and acceptable in Thai women. Compare
d to Caucasian women, the incidences of irregular bleeding and side ef
fects were apparently lower in these Asian women. Furthermore, the eff
ects of both oral contraceptives were comparable.