Comparative Pharmacology
Head-to-head clinical analysis: DEMULEN 1 35 21 versus TRI LO MILI.
Peer-Reviewed Evidence
Head-to-head clinical analysis: DEMULEN 1 35 21 versus TRI LO MILI.
DEMULEN 1/35-21 vs TRI-LO-MILI
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: ethinyl estradiol suppresses gonadotropin release via negative feedback on the hypothalamic-pituitary axis; norgestimate binds to progesterone receptors, inhibiting ovulation and altering cervical mucus and endometrial receptivity.
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 7 days of placebo.
None Documented
None Documented
Ethinyl estradiol: 13±3 hours (terminal); norethindrone: 8±3 hours. Steady-state achieved after ~5 days.
Terminal elimination half-life: 20-24 hours; allows once-daily dosing for contraceptive efficacy.
Renal (primarily as glucuronide and sulfate conjugates): ~60%; fecal: ~40%
Renal: approximately 50% as metabolites; biliary/fecal: approximately 40% as metabolites; 10% unchanged in urine.
Category C
Category C
Oral Contraceptive
Oral Contraceptive