Comparative Pharmacology
Head-to-head clinical analysis: DEMULEN 1 35 28 versus MODICON 28.
Peer-Reviewed Evidence
Head-to-head clinical analysis: DEMULEN 1 35 28 versus MODICON 28.
DEMULEN 1/35-28 vs MODICON 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 hormonal contraceptive: ethinyl estradiol suppresses gonadotropin release, inhibiting ovulation; norethindrone induces changes in cervical mucus and endometrium, impeding sperm penetration and implantation.
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, 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
Ethinyl estradiol: 17.4 ± 5.6 h (terminal); norethindrone: 10.9 ± 1.6 h (terminal); clinically, steady-state achieved within 5-7 days.
Terminal elimination half-life: 13-19 hours (mean 16 hours) for norethindrone; steady state achieved within 5-7 days.
Renal 50% (metabolites), fecal 50% (biliary elimination of conjugates).
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