Comparative Pharmacology
Head-to-head clinical analysis: DEMULEN 1 35 21 versus HAILEY FE 1 5 30.
Peer-Reviewed Evidence
Head-to-head clinical analysis: DEMULEN 1 35 21 versus HAILEY FE 1 5 30.
DEMULEN 1/35-21 vs HAILEY FE 1.5/30
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 estrogen-progestin contraceptive that suppresses gonadotropin release (FSH and LH) from the pituitary, inhibiting ovulation. Additionally, increases viscosity of cervical mucus and alters 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 consecutive days, followed by 7 days of placebo tablets.
None Documented
None Documented
Ethinyl estradiol: 13±3 hours (terminal); norethindrone: 8±3 hours. Steady-state achieved after ~5 days.
Ethinyl estradiol: terminal half-life ~17-24 hours; norethindrone: terminal half-life ~5-14 hours (mean 11 hours). The clinical significance is that steady-state is reached within 5-7 days.
Renal (primarily as glucuronide and sulfate conjugates): ~60%; fecal: ~40%
Ethinyl estradiol is primarily excreted renally (40-45%) and via bile/feces (45-55%). Norethindrone is excreted 50-60% renally and 30-40% fecally.
Category C
Category C
Oral Contraceptive
Oral Contraceptive