Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 1 35 28 versus ORTHO NOVUM 1 50 21.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ORTHO NOVUM 1 35 28 versus ORTHO NOVUM 1 50 21.
ORTHO-NOVUM 1/35-28 vs ORTHO-NOVUM 1/50 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 oral contraceptive consisting of mestranol (estrogen) and norethindrone (progestin). Mestranol is converted to ethinyl estradiol, which suppresses gonadotropin release (FSH, LH) from the pituitary, inhibiting ovulation. Norethindrone induces changes in cervical mucus (increasing viscosity) and endometrial lining, creating a hostile environment for sperm implantation.
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 tablet-free days. Each tablet contains 1 mg norethindrone and 50 mcg mestranol.
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: biphasic terminal half-life 7-9 hours for parent compound, 8-11 hours for metabolites; clinical steady-state achieved after 5-7 days.
Renal 50-60% as metabolites; fecal 30-40% via biliary elimination; <1% unchanged in urine.
Renal 50-60% as glucuronide and sulfate conjugates of norethindrone and mestranol/metabolites; fecal 20-30% via biliary elimination.
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive