Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 7 14 28 versus TRI LEGEST 21.
Head-to-head clinical analysis: ORTHO NOVUM 7 14 28 versus TRI LEGEST 21.
ORTHO-NOVUM 7/14-28 vs TRI-LEGEST 21
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing ethinyl estradiol and norethindrone. Suppresses gonadotropin release (FSH, LH) via negative feedback, inhibiting ovulation. Also increases cervical mucus viscosity and alters endometrial receptivity.
Combination estrogen-progestin contraceptive; suppresses gonadotropins (FSH, LH), inhibits ovulation, alters cervical mucus and endometrium.
One tablet daily for 28 days; each tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg (days 1-7), norethindrone 0.75 mg and ethinyl estradiol 0.035 mg (days 8-14), norethindrone 1 mg and ethinyl estradiol 0.035 mg (days 15-21), and placebo (days 22-28). Take at same time each day.
One tablet orally once daily for 21 days, followed by 7 tablet-free days. Each tablet contains norgestimate 0.18 mg/ethinyl estradiol 0.025 mg (days 1-7), norgestimate 0.215 mg/ethinyl estradiol 0.025 mg (days 8-14), norgestimate 0.25 mg/ethinyl estradiol 0.025 mg (days 15-21).
None Documented
None Documented
Ethinyl estradiol: ~13-27 h (mean 17 h); Norethindrone: ~5-14 h (mean 8 h). Clinical context: steady-state achieved after ~5 days; half-life supports daily dosing.
Ethinyl estradiol: 13-27 hours (mean ~17 hours); norgestimate active metabolite (norelgestromin): 22-36 hours (mean ~28 hours). Steady-state achieved within 5-10 days.
Renal: ~50-60% (metabolites); biliary/fecal: ~30-40% (metabolites); unchanged drug <1% in urine.
Renal: approximately 50-60% as metabolites; fecal: approximately 40-50% (ethinyl estradiol and norgestimate metabolites excreted in bile and feces); less than 1% unchanged in urine.
Category C
Category C
Oral Contraceptive
Oral Contraceptive