Comparative Pharmacology
Head-to-head clinical analysis: GILDESS FE 1 20 versus ORTHO NOVUM 7 14 21.
Peer-Reviewed Evidence
Head-to-head clinical analysis: GILDESS FE 1 20 versus ORTHO NOVUM 7 14 21.
GILDESS FE 1/20 vs ORTHO-NOVUM 7/14-21
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive: ethinyl estradiol suppresses gonadotropin release; norethindrone induces progestational changes in endometrium and cervical mucus, preventing ovulation and fertilization.
Combination estrogen-progestin contraceptive: suppresses gonadotropin release, inhibits ovulation, thickens cervical mucus, alters endometrial receptivity.
One tablet orally once daily for 21 days followed by 7 placebo tablets per 28-day cycle.
One tablet containing 0.5 mg norethindrone/0.035 mg ethinyl estradiol (white tablets) on days 1-14, then one tablet containing 1 mg norethindrone/0.035 mg ethinyl estradiol (peach tablets) on days 15-21, then no tablets for 7 days; repeated cycles.
None Documented
None Documented
Ethinyl estradiol: terminal half-life approximately 13 hours (range 10-15 h). Desogestrel: metabolized to etonogestrel; etonogestrel terminal half-life about 28 hours (range 20-40 h). Clinical context: steady-state reached within 7-10 days.
Norethindrone: 10-12 hours (terminal), ethinyl estradiol: 13-27 hours (terminal); clinical context: steady state achieved within 5-7 days
Approximately 60-65% renal (as metabolites), 30-35% fecal (as metabolites and unchanged drug). Ethinyl estradiol and desogestrel metabolites are excreted primarily via urine and feces. Etonogestrel (active metabolite) is excreted mainly via feces (40%) and urine (32%).
Renal: ~40% as glucuronide and sulfate conjugates; Fecal: ~20%; Biliary: minor
Category C
Category C
Oral Contraceptive
Oral Contraceptive