Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 1 50 21 versus ORTHO TRI CYCLEN 28.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ORTHO NOVUM 1 50 21 versus ORTHO TRI CYCLEN 28.
ORTHO-NOVUM 1/50 21 vs ORTHO TRI-CYCLEN 28
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive consisting of mestranol (estrogen) and norethindrone (progestin). Mestranol is converted to ethinyl estradiol, which suppresses gonadotropin release (FSH, LH) from the pituitary, inhibiting ovulation. Norethindrone induces changes in cervical mucus (increasing viscosity) and endometrial lining, creating a hostile environment for sperm implantation.
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 orally once daily for 21 days, followed by 7 tablet-free days. Each tablet contains 1 mg norethindrone and 50 mcg mestranol.
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: biphasic terminal half-life 7-9 hours for parent compound, 8-11 hours for metabolites; clinical steady-state achieved after 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 glucuronide and sulfate conjugates of norethindrone and mestranol/metabolites; fecal 20-30% via biliary elimination.
Renal: ~60% (metabolites); Fecal: ~40% (metabolites); unchanged drug <1%
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive