Comparative Pharmacology
Head-to-head clinical analysis: DEMULEN 1 35 21 versus HAILEY 1 5 30.
Head-to-head clinical analysis: DEMULEN 1 35 21 versus HAILEY 1 5 30.
DEMULEN 1/35-21 vs HAILEY 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 oral contraceptive containing ethinyl estradiol and desogestrel. Ethinyl estradiol suppresses gonadotropin release via negative feedback on the hypothalamic-pituitary axis; desogestrel, a progestin, inhibits ovulation and alters 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 (ethinyl estradiol 0.03 mg, levonorgestrel 0.15 mg) orally once daily at the same time each day for 21 days, followed by 7 placebo tablets. For continuous cycling, may take active tablets daily without 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 of ethinyl estradiol is 13-27 hours (mean 17 hours); for norgestimate, active metabolite norelgestromin has half-life 12-30 hours (mean 19 hours). Steady state reached after 7-14 days.
Renal (primarily as glucuronide and sulfate conjugates): ~60%; fecal: ~40%
Approximately 40% renal (as metabolites), 32% fecal (as metabolites), and <1% unchanged in urine.
Category C
Category C
Oral Contraceptive
Oral Contraceptive