Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 1 35 28 versus ORTHO NOVUM 2 21.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ORTHO NOVUM 1 35 28 versus ORTHO NOVUM 2 21.
ORTHO-NOVUM 1/35-28 vs ORTHO-NOVUM 2-21
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 of estrogen (ethinyl estradiol) and progestin (norethindrone) inhibits ovulation via negative feedback on the hypothalamic-pituitary-ovarian axis, suppressing gonadotropin release. Additionally, induces changes in cervical mucus and endometrium.
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 days followed by 7 days off. Each tablet contains norethindrone 2 mg and ethinyl estradiol 0.1 mg.
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 5-12 hours; ethinyl estradiol: terminal half-life 7-20 hours (enterohepatic recirculation may prolong effect). Steady-state achieved after 5-7 days.
Renal 50-60% as metabolites; fecal 30-40% via biliary elimination; <1% unchanged in urine.
Renal (approx. 60% as metabolites), fecal (approx. 40% as metabolites). Norethindrone and ethinyl estradiol are extensively metabolized; less than 5% excreted unchanged in urine.
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive