Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 7 7 7 21 versus QUARTETTE.
Head-to-head clinical analysis: ORTHO NOVUM 7 7 7 21 versus QUARTETTE.
ORTHO-NOVUM 7/7/7-21 vs QUARTETTE
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combined hormonal contraceptive; primarily suppresses ovulation via inhibition of gonadotropin release (LH and FSH) from the pituitary. Also induces changes in cervical mucus and endometrium.
Combination oral contraceptive containing drospirenone, ethinyl estradiol, levomefolate calcium, and metformin. Drospirenone is a progestin with antimineralocorticoid and antiandrogenic activity. Ethinyl estradiol is an estrogen. Levomefolate calcium is a folate supplement. Metformin is a biguanide that decreases hepatic glucose production and improves insulin sensitivity.
One tablet orally once daily for 21 days, followed by 7 days of no tablets. Each tablet contains norethindrone 0.5 mg/0.75 mg/1 mg and ethinyl estradiol 35 mcg, with biphasic or triphasic dosing per cycle.
3 mg orally once daily for 21 days followed by 7 days of placebo.
None Documented
None Documented
Ethinyl estradiol: 13-27 hours; norethindrone: 8-14 hours; with multiple dosing, steady state after 5-7 days.
Terminal elimination half-life is 12-14 hours; clinically this supports once-daily dosing with steady state achieved within 2-3 days.
Renal: <10% unchanged; biliary/fecal: ~50% as metabolites; extensive enterohepatic recirculation.
Renal excretion accounts for 55% (primarily as unchanged drug), biliary/fecal excretion 35%, and the remainder undergoes metabolic clearance.
Category C
Category C
Oral Contraceptive
Oral Contraceptive