Comparative Pharmacology
Head-to-head clinical analysis: CYCLAFEM 1 35 versus KELNOR.
Peer-Reviewed Evidence
Head-to-head clinical analysis: CYCLAFEM 1 35 versus KELNOR.
CYCLAFEM 1/35 vs KELNOR
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing ethinyl estradiol and norethindrone. Suppresses gonadotropin (FSH, LH) secretion via estrogen and progestin negative feedback, inhibiting ovulation. Progestin alters cervical mucus (sperm penetration) and endometrial receptivity.
Combined oral contraceptive; inhibits ovulation by suppressing gonadotropin release (FSH and LH) primarily via progestational activity; increases viscosity of cervical mucus to inhibit sperm penetration; alters endometrium.
One tablet orally once daily. Each tablet contains 1 mg norethindrone and 0.035 mg ethinyl estradiol. Administer daily for 21 days followed by 7 days of placebo or no tablet.
KELNOR (norethindrone acetate and ethinyl estradiol) is a combined oral contraceptive. Typical adult dose: 1 tablet (norethindrone acetate 1 mg/ethinyl estradiol 20 mcg) orally once daily for 21 days, followed by 7 placebo tablets, starting on day 1 of menstrual cycle.
None Documented
None Documented
Half-life of norethindrone is 5-14 hours; ethinyl estradiol is 10-20 hours. Steady state reached after 5-7 days.
Terminal elimination half-life 12-15 hours; clinically relevant for once-daily dosing.
Renal 40-60% as glucuronide and sulfate conjugates, biliary/fecal 20-40%.
Primarily renal excretion of unchanged drug (70-80%) and glucuronide conjugate (10-15%); biliary/fecal elimination accounts for <5%.
Category C
Category C
Oral Contraceptive
Oral Contraceptive