MULTICENTER TRIAL OF 2 MONOPHASIC ORAL-CONTRACEPTIVES CONTAINING 30 MCG ETHINYLESTRADIOL AND EITHER DESOGESTREL OR GESTODENE IN THAI WOMEN

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.