Comparative Pharmacology
Head-to-head clinical analysis: LEVORA 0 15 30 28 versus SIMPESSE.
Peer-Reviewed Evidence
Head-to-head clinical analysis: LEVORA 0 15 30 28 versus SIMPESSE.
LEVORA 0.15/30-28 vs SIMPESSE
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing ethinyl estradiol and levonorgestrel. Suppresses gonadotropin (FSH and LH) release from the pituitary, inhibiting ovulation. Also induces changes in cervical mucus (increasing viscosity) and endometrium (reducing receptivity) to impair sperm penetration and implantation.
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 at the same time each day for 28 days (21 active tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, followed by 7 placebo tablets).
Oral: 10 mg once daily, taken at least 1 hour before a meal.
None Documented
None Documented
Ethinyl estradiol: 13-27 hours (terminal); Levonorgestrel: 11-45 hours (terminal, dose-dependent due to SHBG binding).
Terminal elimination half-life is 24 hours (range 20-28 hours), supporting once-daily dosing.
Renal: ~50% (as glucuronide and sulfate conjugates of ethinyl estradiol and levonorgestrel); Fecal: ~50% (enterohepatic recirculation).
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