Comparative Pharmacology
Head-to-head clinical analysis: ORTHO CYCLEN 28 versus ORTHO TRI CYCLEN 28.
Head-to-head clinical analysis: ORTHO CYCLEN 28 versus ORTHO TRI CYCLEN 28.
ORTHO CYCLEN-28 vs ORTHO TRI-CYCLEN 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 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 (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 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
Ethinyl estradiol: 13-27 hours; Norelgestromin (active metabolite of norgestimate): 28-52 hours. Terminal half-lives support once-daily dosing.
Norethindrone: ~8 hours; Ethinyl estradiol: ~15 hours (biphasic, terminal: 15-20 hours). Steady-state achieved within 7-14 days.
Renal (60-70% as metabolites, ~20% unchanged), Fecal (30-40% as metabolites); primarily conjugated metabolites of ethinyl estradiol and norgestimate.
Renal: ~60% (metabolites); Fecal: ~40% (metabolites); unchanged drug <1%
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive