Comparative Pharmacology
Head-to-head clinical analysis: MICROGESTIN FE 1 20 versus SIMPESSE.
Peer-Reviewed Evidence
Head-to-head clinical analysis: MICROGESTIN FE 1 20 versus SIMPESSE.
MICROGESTIN FE 1/20 vs SIMPESSE
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing ethinyl estradiol (estrogen) and norethindrone acetate (progestin). Suppresses gonadotropins via negative feedback on hypothalamic-pituitary axis, inhibiting ovulation; increases cervical mucus viscosity and alters endometrial lining.
Simpesse is a combination estrogen-progestin oral contraceptive that suppresses gonadotropin release, primarily inhibiting ovulation via negative feedback on the hypothalamic-pituitary-ovarian axis. Additionally, it alters cervical mucus viscosity and endometrial receptivity.
One tablet orally once daily, containing norethindrone acetate 1 mg and ethinyl estradiol 20 mcg, taken at the same time each day for 21 days followed by 7 days of placebo (iron tablets) or continuous cycling per prescribing information.
Oral: 10 mg once daily, taken at least 1 hour before a meal.
None Documented
None Documented
Norethindrone: 5-14 hours (mean 8 hours); Ethinyl estradiol: 12-24 hours (mean 18 hours); Steady-state in 5-7 days
Terminal elimination half-life is 24 hours (range 20-28 hours), supporting once-daily dosing.
Renal: ~50-60% as metabolites; Fecal: ~30-40% as metabolites; Biliary: minor; <1% unchanged
Renal excretion of unchanged drug accounts for approximately 60-70% of elimination; hepatic metabolism produces inactive metabolites that are excreted renally (20-30%) and fecally (<10%).
Category C
Category C
Oral Contraceptive
Oral Contraceptive