Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 1 35 28 versus ORTHO NOVUM 1 80 21.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ORTHO NOVUM 1 35 28 versus ORTHO NOVUM 1 80 21.
ORTHO-NOVUM 1/35-28 vs ORTHO-NOVUM 1/80 21
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing ethinyl estradiol and norethindrone. Inhibits ovulation by suppressing gonadotropin release (FSH and LH) from the pituitary; increases viscosity of cervical mucus, impeding sperm penetration; alters endometrial lining, reducing implantation likelihood.
Combination estrogen-progestin contraceptive. Suppresses gonadotropin (FSH, LH) release from pituitary, inhibiting ovulation. Increases viscosity of cervical mucus, impeding sperm penetration. Induces endometrial thinning, reducing implantation likelihood.
1 tablet (norethindrone 1 mg / ethinyl estradiol 35 mcg) orally once daily for 28 consecutive days. Placebo tablets on days 22-28 if included.
One tablet orally once daily for 21 consecutive days, followed by 7 days off therapy.
None Documented
None Documented
Norethindrone: 5-14 hrs (terminal); ethinyl estradiol: 10-24 hrs. Steady-state achieved within 5-7 days; terminal half-life supports once-daily dosing.
Norethindrone terminal half-life: 8-11 hours; Mestranol (ethinyl estradiol pro-drug) terminal half-life: 10-15 hours (metabolite ethinyl estradiol). Clinical context: Steady-state reached in 5-7 days; once-daily dosing maintains therapeutic levels.
Renal 50-60% as metabolites; fecal 30-40% via biliary elimination; <1% unchanged in urine.
Renal: ~60% (metabolites, primarily glucuronide and sulfate conjugates), Fecal: ~40% (biliary excretion of metabolites). Unchanged drug negligible.
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive