Comparative Pharmacology
Head-to-head clinical analysis: ORTHO CYCLEN 28 versus ORTHO NOVUM 1 35 21.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ORTHO CYCLEN 28 versus ORTHO NOVUM 1 35 21.
ORTHO CYCLEN-28 vs ORTHO-NOVUM 1/35-21
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; suppresses gonadotropin (FSH and LH) secretion via negative feedback, inhibiting ovulation. Increases cervical mucus viscosity and alters endometrial lining, impairing sperm penetration and implantation.
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 for 21 days, followed by 7 placebo tablets. Each tablet contains 1 mg norethindrone and 0.035 mg ethinyl estradiol.
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: 7-9 hours (terminal); Ethinyl estradiol: 13-27 hours (terminal). At steady state, clinical contraceptive efficacy is maintained with daily dosing.
Renal (60-70% as metabolites, ~20% unchanged), Fecal (30-40% as metabolites); primarily conjugated metabolites of ethinyl estradiol and norgestimate.
Renal (approx. 40% as metabolites, <10% unchanged), fecal (approx. 60% as metabolites, primarily via bile).
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive