Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 1 50 28 versus ORTHO TRI CYCLEN 28.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ORTHO NOVUM 1 50 28 versus ORTHO TRI CYCLEN 28.
ORTHO-NOVUM 1/50 28 vs ORTHO TRI-CYCLEN 28
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive; suppresses gonadotropin secretion (FSH, LH) via estrogen and progestin, inhibiting ovulation, increasing cervical mucus viscosity, and altering endometrial structure.
Combination of ethinyl estradiol and norgestimate primarily suppresses gonadotropin (FSH and LH) secretion via negative feedback on the hypothalamic-pituitary-ovarian axis, inhibiting ovulation. Additionally, it increases cervical mucus viscosity and alters endometrial structure to impede fertilization and implantation.
One tablet (1 mg norethindrone/50 mcg mestranol) orally once daily for 21 days, followed by 7 days of placebo tablets (inactive) for a 28-day cycle.
One tablet daily for 28 days: 21 active tablets (norgestimate 0.180 mg/ethinyl estradiol 0.035 mg, norgestimate 0.215 mg/ethinyl estradiol 0.035 mg, norgestimate 0.250 mg/ethinyl estradiol 0.035 mg) followed by 7 inert tablets. Route: oral.
None Documented
None Documented
Norethindrone: 5-12 h (mean 8 h); Mestranol: 12-24 h (mean 18 h); steady-state reached within 5-7 days
Norethindrone: ~8 hours; Ethinyl estradiol: ~15 hours (biphasic, terminal: 15-20 hours). Steady-state achieved within 7-14 days.
Renal: ~50-60% as metabolites; fecal: ~30-40% as metabolites; biliary: <10%
Renal: ~60% (metabolites); Fecal: ~40% (metabolites); unchanged drug <1%
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive