Comparative Pharmacology
Head-to-head clinical analysis: ORTHO CYCLEN 28 versus ORTHO NOVUM 1 80 28.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ORTHO CYCLEN 28 versus ORTHO NOVUM 1 80 28.
ORTHO CYCLEN-28 vs ORTHO-NOVUM 1/80 28
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing ethinyl estradiol and norgestimate. The primary mechanism is inhibition of gonadotropin secretion (FSH and LH) via negative feedback on the hypothalamic-pituitary axis, thereby suppressing ovulation. Additional effects include thickening of cervical mucus (impedes sperm penetration) and alterations in the endometrium (reduces implantation likelihood).
Combination estrogen-progestin contraceptive; primarily inhibits ovulation by suppressing gonadotropin release (FSH and LH). Also increases cervical mucus viscosity and alters endometrial receptivity.
One tablet (0.18 mg norgestimate/0.035 mg ethinyl estradiol) orally once daily for 28 days, first tablet on day 1 of menstrual cycle with 7 placebo tablets in last 7 days.
One tablet orally once daily at the same time each day for 28 days (21 active tablets containing norethindrone 1 mg and ethinyl estradiol 80 mcg, followed by 7 placebo tablets).
None Documented
None Documented
Ethinyl estradiol: 13-27 hours; Norelgestromin (active metabolite of norgestimate): 28-52 hours. Terminal half-lives support once-daily dosing.
Norethindrone: 7-8 hours; mestranol: 10-13 hours (terminal). Steady-state achieved in 5-7 days.
Renal (60-70% as metabolites, ~20% unchanged), Fecal (30-40% as metabolites); primarily conjugated metabolites of ethinyl estradiol and norgestimate.
Norethindrone: 50-60% renal, 20-30% fecal; mestranol: 30-40% renal, 60-70% fecal.
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive