Comparative Pharmacology
Head-to-head clinical analysis: LESSINA 28 versus NORLESTRIN FE 1 50.
Head-to-head clinical analysis: LESSINA 28 versus NORLESTRIN FE 1 50.
LESSINA-28 vs NORLESTRIN FE 1/50
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination of a progestin (levonorgestrel) and an estrogen (ethinyl estradiol). Inhibits ovulation by suppressing gonadotropin release; increases cervical mucus viscosity to impede sperm penetration, and induces endometrial changes that reduce implantation likelihood.
Combination of ethinyl estradiol and norethindrone acetate provides negative feedback on gonadotropin release, suppressing ovulation. Also causes cervical mucus thickening and endometrial thinning.
One tablet (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) orally once daily for 28 days, starting on the first day of menstrual cycle.
One tablet (norethindrone 1 mg and ethinyl estradiol 50 mcg plus ferrous fumarate 75 mg) orally once daily for 28 days, with 21 active tablets and 7 placebo tablets.
None Documented
None Documented
Terminal elimination half-life: 18-22 hours; clinically relevant for once-daily dosing.
Norethindrone: 5-12 hours (mean 8 hours). Ethinyl estradiol: 11-16 hours. Clinical context: Steady state reached in 5-7 days.
Renal: 30% as unchanged drug and metabolites; biliary/fecal: 70% as metabolites.
Norethindrone: 20% renal, 80% fecal. Ethinyl estradiol: 40% renal, 60% fecal.
Category C
Category C
Oral Contraceptive
Oral Contraceptive