Clinical comparative study of oral contraceptives containing 30 μg ethinylestradiol/150 μg levonorgestrel, and 35 μg ethinylestradiol/250 μg norgestimate in Thai women

The. study was conducted to compare cycle control; efficacy and side effects of two oral contraceptives containing 30 mug ethinylestradiol (EE)/150 mug levonorgestrel (LNG) and 35 mug ethinylestradiol (EE)/250 mug norgestimate (NGM). An open-label, randomized, comparative study was conducted in which 140 healthy women received the 30 mug EE/150 mug LNG or 35 mug EE/250 mug NGM preparation for six treatment cycles. There were no-significant statistical differences between both groups in terms of cycle length and amount of withdrawal bleeding. The mean duration in the 35 mug EE/250 mug NGM group was longer than 30 mug EE/150 mug LNG group with significant statistical difference. More patients in 35 mug EE/250 mug NGM group experienced BTT at each cycle compared with the 30 mug EE/150 mug LNG group, but was not statistically significant. There was no amenorrhea nor pregnancies occurring in either group. No significant changes in body weight or blood pressure were found in both groups. The incidence of adverse events in both groups was low and tended to decrease with time. Statistically significant differences were observed for headache and dizziness, which occurred more in the 30 mug EE/150 mug LNG group. In conclusion, 35 mug EE/250 mug NGM provides reliable contraceptive efficacy. It also provides good cycle control equal to 30 mug EE/150 mug LNG with a lower incidence of minor adverse effects such as headache and dizziness compared to 30 mug EE/150 mug LNG. (C) 2002 Elsevier Science Inc. All rights reserved.