Experience with a new low dose oral contraceptive: norgestimate & ethinyl estradiol.

ABSTRACT

Experience with cyclic administration of 0.125 mg of norgestimate plus 0.035 mg of ethinyl estradiol indicates that this new combined oral contraceptive is clinically effective and well tolerated. There were no unintended pregnancies in 3,026 cycles of use among 161 women. Patient acceptability of a relatively high cycle incidence of spotting (16.7%) was remarkable; only five patients withdrew from the study because of this irregularity. Breakthrough bleeding was infrequent (0.9% of total cycles). No other side effects were reported and amenorrheic cycles were not observed. In particular there were no complaints of gastrointestinal disturbance. Weight remained unusually stable. Laboratory findings remained within normal limits over 6 months of drug use. However, serum cholesterol and serum glutamic pyruvic transaminase levels declined and protein bound iodine increased significantly from pre-treatment levels.

ABSTRACT

PIP A clinical investigation was conducted to test and evaluate a new low-dose oral contraceptive, a combination produce containing 0.125 mg of norgestimate and 0.035 mg of ethinyl estradiol, developed with a view to minimizing extragonadal effects. Of the 161 fertile women observed during 3062 menstrual cycles, 91 were 'fresh' subjects, 70 were 'switch' subjects. No pregnancies occurred. The average number of cycle days remained almost constant. There was a decrease in the number of days of flow in 55.7, an increase in 9.7, and no change in 34.5% of all treatment cycles. The amount of menstrual flow decreased in 33.8, increased in 11.2, and remained moderate in 61.6% of all cycles. The incidence of spotting was relatively high -- 79.5% of all subjects in 16.7% of all cycles. Breakthrough bleeding was insignificant. Dysmenorrhea and premenstrual tension, which had been reported in 24.4 and 58.3% of pre-treatment cycles respectively, diminished. No incidents of amenorrhea or gastrointinal disturbance were reported. The laboratory findings included the following significant results: 1) a decrease in serum cholesterol from 188.90 to 180.98 mg/100 ml at 6 months; 2) a reduction in serum glutamic pyruvic transaminase; and 3) an expected rise in protein bound iodine.