Comparative Pharmacology
Head-to-head clinical analysis: NORLESTRIN FE 1 50 versus OVULEN.
Peer-Reviewed Evidence
Head-to-head clinical analysis: NORLESTRIN FE 1 50 versus OVULEN.
NORLESTRIN FE 1/50 vs OVULEN
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination of ethinyl estradiol and norethindrone acetate provides negative feedback on gonadotropin release, suppressing ovulation. Also causes cervical mucus thickening and endometrial thinning.
Ovulen is a combination oral contraceptive containing ethynodiol diacetate (a progestin) and mestranol (an estrogen). It inhibits ovulation by suppressing gonadotropin-releasing hormone (GnRH) from the hypothalamus, reducing luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from the pituitary. It also increases cervical mucus viscosity and alters endometrial development, impeding sperm penetration and implantation.
One tablet (norethindrone 1 mg and ethinyl estradiol 50 mcg plus ferrous fumarate 75 mg) orally once daily for 28 days, with 21 active tablets and 7 placebo tablets.
1 tablet (1 mg ethynodiol diacetate, 50 mcg mestranol) orally once daily for 21 days, followed by 7 days of placebo or no medication.
None Documented
None Documented
Norethindrone: 5-12 hours (mean 8 hours). Ethinyl estradiol: 11-16 hours. Clinical context: Steady state reached in 5-7 days.
Ethinylestradiol: 10-20 hours (mean 17 hours); Dimethisterone: 10-15 hours. Clinical context: Steady state achieved after 3-5 days; elimination prolonged in hepatic impairment.
Norethindrone: 20% renal, 80% fecal. Ethinyl estradiol: 40% renal, 60% fecal.
Renal: 50-60% as metabolites (glucuronide and sulfate conjugates), biliary/fecal: 40-50% (enterohepatic circulation).
Category C
Category C
Oral Contraceptive
Oral Contraceptive