Comparative Pharmacology
Head-to-head clinical analysis: DEMULEN 1 50 21 versus MODICON 28.
Peer-Reviewed Evidence
Head-to-head clinical analysis: DEMULEN 1 50 21 versus MODICON 28.
DEMULEN 1/50-21 vs MODICON 28
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
DEMULEN 1/50-21 is a combined oral contraceptive containing ethinyl estradiol and ethynodiol diacetate. Ethinyl estradiol and progestins inhibit gonadotropin release (FSH and LH) from the pituitary, suppressing ovulation. Progestins also increase cervical mucus viscosity and alter endometrial receptivity, impeding sperm penetration and implantation.
Combination hormonal contraceptive: ethinyl estradiol suppresses gonadotropin release, inhibiting ovulation; norethindrone induces changes in cervical mucus and endometrium, impeding sperm penetration and implantation.
1 tablet (ethinyl estradiol 50 mcg, norethindrone 1 mg) orally once daily for 21 days, followed by 7 days off.
One tablet orally once daily, each tablet containing 0.035 mg ethinyl estradiol and 0.4 mg norethindrone, taken at the same time each day for 21 days followed by 7 days of placebo tablets.
None Documented
None Documented
Ethinylestradiol: 13 ± 3 h (biphasic; terminal phase used for dosing interval). Clinical context: steady-state achieved after ~3 days; missed dose may reduce contraceptive efficacy if >36 h.
Terminal elimination half-life: 13-19 hours (mean 16 hours) for norethindrone; steady state achieved within 5-7 days.
Renal (approx. 50% as metabolites, <1% unchanged), fecal (approx. 40%, largely as ethinylestradiol conjugates), biliary (minor, enterohepatic recirculation of ethinylestradiol)
Renal: 50-60% as metabolites, fecal: 40-50% as metabolites, with enterohepatic circulation; less than 1% unchanged in urine.
Category C
Category C
Combination Oral Contraceptive
Combination Oral Contraceptive