Comparative Pharmacology
Head-to-head clinical analysis: CYCLAFEM 0 5 35 versus OVRAL.
Peer-Reviewed Evidence
Head-to-head clinical analysis: CYCLAFEM 0 5 35 versus OVRAL.
CYCLAFEM 0.5/35 vs OVRAL
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing norethindrone (progestin) and ethinyl estradiol (estrogen). Inhibits gonadotropin release, suppressing ovulation. Increases cervical mucus viscosity and alters endometrium, reducing sperm penetration and implantation.
OVRAL is a combination oral contraceptive containing ethinyl estradiol and norgestrel. It inhibits ovulation by suppressing gonadotropin-releasing hormone (GnRH) secretion from the hypothalamus, reducing follicle-stimulating hormone (FSH) and luteinizing hormone (LH) release from the pituitary. Additionally, it increases cervical mucus viscosity and alters endometrial receptivity, impeding sperm penetration and implantation.
One tablet (0.5 mg norethindrone/35 mcg ethinyl estradiol) orally once daily for 21 days, followed by 7 placebo days (or no tablets) per cycle.
One tablet (norgestrel 0.3 mg with ethinyl estradiol 0.03 mg) orally once daily for 21 days followed by 7 days of placebo.
None Documented
None Documented
Terminal elimination half-life of norethindrone is 5-14 hours (mean 7.6 hours); ethinyl estradiol half-life is 7-20 hours (mean ~13 hours). Steady-state is achieved within 5-7 days.
Norgestrel: 24–32 hours; Ethinyl estradiol: 12–18 hours; steady-state achieved after 5–7 days
Renal excretion accounts for approximately 50-60% of the dose (as metabolites), with 30-40% excreted in feces via biliary elimination. Unchanged drug is minimal in urine.
Renal (60% as metabolites, ~40% unchanged); biliary/fecal (40%)
Category C
Category C
Oral Contraceptive
Oral Contraceptive