Comparative Pharmacology
Head-to-head clinical analysis: DEMULEN 1 35 21 versus TRI NORINYL 28 DAY.
Peer-Reviewed Evidence
Head-to-head clinical analysis: DEMULEN 1 35 21 versus TRI NORINYL 28 DAY.
DEMULEN 1/35-21 vs TRI-NORINYL 28-DAY
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing ethinyl estradiol (estrogen) and ethynodiol diacetate (progestin). Inhibits gonadotropin secretion (FSH, LH) via negative feedback on hypothalamic-pituitary axis, suppressing ovulation. Additionally, thickens cervical mucus and alters endometrial receptivity.
Combination oral contraceptive containing ethinyl estradiol and norethindrone. Suppresses gonadotropin (FSH and LH) release via negative feedback, inhibiting ovulation. Also increases viscosity of cervical mucus and alters endometrial lining to reduce implantation likelihood.
One tablet orally once daily for 21 days, followed by 7 days off. Each tablet contains 1 mg ethynodiol diacetate and 35 mcg ethinyl estradiol.
One tablet orally once daily for 21 days, followed by one placebo tablet orally once daily for 7 days. Each active tablet contains 0.035 mg ethinyl estradiol and 0.5 mg norethindrone (7 days), 0.035 mg ethinyl estradiol and 1.0 mg norethindrone (9 days), and 0.035 mg ethinyl estradiol and 0.5 mg norethindrone (5 days).
None Documented
None Documented
Ethinyl estradiol: 13±3 hours (terminal); norethindrone: 8±3 hours. Steady-state achieved after ~5 days.
Ethinyl estradiol: 17 ± 6 hours (terminal); Norethindrone: 10 ± 3 hours (terminal). Steady-state achieved after 7-14 days.
Renal (primarily as glucuronide and sulfate conjugates): ~60%; fecal: ~40%
Renal: 40% as metabolites; Fecal: 50% as metabolites; Biliary: minor; unchanged ethinyl estradiol excreted in urine <5%, norethindrone <1%.
Category C
Category C
Oral Contraceptive
Oral Contraceptive