A multicenter randomized comparison of cycle control and laboratory findings with oral contraceptive agents containing 100 microg levonorgestrel with 20 microg ethinyl estradiol or triphasic norethindrone with ethinyl estradiol.
OBJECTIVE
This study was undertaken to compare the effects of 2 oral contraceptive regimens on menstrual cycle control and laboratory findings.


METHODS
In a multicenter randomized study 100 microg levonorgestrel with 20 microg ethinyl estradiol (Alesse or Loette) was given to 155 healthy women. A triphasic preparation of 500, 750, and 1000 microg norethindrone with 35 microg ethinyl estradiol (Ortho-Novum 7/7/7 or TriNovum) was given to 167 women for 1 to 4 cycles of treatment.


RESULTS
Overall, the percentages of normal menstrual cycles and the percentages of cycles with intermenstrual and withdrawal bleeding were similar between the 2 treatment groups. In the levonorgestrel with ethinyl estradiol group, there was a statistically significantly longer latent period and a statistically significantly shorter withdrawal bleeding episode. Adverse events were similar between treatment groups, and none were serious. Most mean changes from baseline laboratory values were comparable between groups, although the mean increase in cholesterol concentration was statistically significantly lower in the levonorgestrel with ethinyl estradiol group. Changes in triglyceride and glucose concentrations were not statistically significantly different between groups.


CONCLUSIONS
Levonorgestrel (100 microg) with ethinyl estradiol (20 microg) provides menstrual cycle control equivalent to that obtained with triphasic norethindrone with ethinyl estradiol (75% higher estrogen dose) with similar safety and tolerability.
Reisman
H
H
Atlanta North Gynecology, PC, Roswell, GA 30075, USA.
Martin
D
D
Gast
M J
MJ
D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects; D001806:Blood Urea Nitrogen; D002784:Cholesterol / Q000097:blood; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004338:Drug Combinations; D045166:Estradiol Congeners / Q000009:adverse effects* / Q000627:therapeutic use; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008597:Menstrual Cycle / Q000187:drug effects; D009640:Norethindrone / Q000008:administration & dosage* / Q000627:therapeutic use
D001786:Blood Glucose; D003271:Contraceptive Agents, Female; D003280:Contraceptives, Oral, Synthetic; D004338:Drug Combinations; D045166:Estradiol Congeners; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; D002784:Cholesterol; D009640:Norethindrone