Comparative Pharmacology
Head-to-head clinical analysis: DEMULEN 1 35 28 versus DEMULEN 1 50 28.
Peer-Reviewed Evidence
Head-to-head clinical analysis: DEMULEN 1 35 28 versus DEMULEN 1 50 28.
DEMULEN 1/35-28 vs DEMULEN 1/50-28
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination estrogen-progestin contraceptive; suppresses gonadotropin release, inhibiting ovulation; increases cervical mucus viscosity, impeding sperm penetration; alters endometrial receptivity.
Combination oral contraceptive: Ethinyl estradiol and ethynodiol diacetate suppress gonadotropin secretion (LH, FSH) via negative feedback, inhibiting ovulation. Ethynodiol diacetate also increases cervical mucus viscosity and induces endometrial changes.
One tablet (contains 1 mg ethynodiol diacetate and 35 mcg ethinyl estradiol) orally once daily at the same time each day for 21 days, followed by 7 days of placebo or no tablets.
One tablet orally once daily for 28 consecutive days per cycle.
None Documented
None Documented
Ethinyl estradiol: 17.4 ± 5.6 h (terminal); norethindrone: 10.9 ± 1.6 h (terminal); clinically, steady-state achieved within 5-7 days.
Ethinylestradiol: terminal elimination half-life ~13-27 hours (mean ~17 hours); ethynodiol diacetate (as norethindrone): terminal elimination half-life ~8-11 hours; clinical context: achieved steady-state within 5-10 days; accumulation not significant due to dose interval.
Renal 50% (metabolites), fecal 50% (biliary elimination of conjugates).
Ethinylestradiol and ethynodiol diacetate are extensively metabolized; urinary excretion accounts for ~40% of ethinylestradiol metabolites and ~50-60% of ethynodiol diacetate metabolites; fecal excretion accounts for ~30% of ethinylestradiol metabolites and ~35% of ethynodiol diacetate metabolites; biliary excretion contributes to enterohepatic circulation.
Category C
Category C
Combination Oral Contraceptive
Combination Oral Contraceptive