Evaluation of the clinical performance of three triphasic oral contraceptives: a multicenter, randomized comparative trial.
Three hundred thirteen women participated in an open, multicenter comparison of the incidence of intermenstrual bleeding (breakthrough bleeding and or spotting) associated with the use of three triphasic oral contraceptives. Triphasil (n = 107), containing levonorgestrel and ethinyl estradiol, and Ortho-Novum 7/7/7 (n = 97) and Tri-Norinyl (n = 109), both of which contain norethindrone and ethinyl estradiol, were administered over four cycles for a total of 1141 cycles. The total incidence of intermenstrual bleeding was significantly lower with Triphasil (17.2%) than with Ortho-Novum 7/7/7 (39.5%) or Tri-Norinyl (49.0%). The pattern remained the same when findings were analyzed cycle by cycle and for breakthrough bleeding and spotting separately. The incidence of other side effects was comparable for all regimens. Results of this study demonstrate superior cycle control with Triphasil compared with Ortho-Novum 7/7/7 and Tri-Norinyl during the first four cycles of use.
Schilling
L H
LH
Student Health Services, California State University, Fresno 93740-0081.
Bolding
O T
OT
Chenault
C B
CB
Chong
A P
AP
Fleury
F
F
Forrest
K
K
Glick
H I
HI
Hasson
H M
HM
Heil
C G
CG
London
R S
RS
D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D003276:Contraceptives, Oral / Q000494:pharmacology*; D003277:Contraceptives, Oral, Combined / Q000494:pharmacology; D003279:Contraceptives, Oral, Sequential / Q000009:adverse effects / Q000494:pharmacology*; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000494:pharmacology; D019304:Ethinyl Estradiol-Norgestrel Combination; D005260:Female; D006801:Humans; D008598:Menstruation / Q000187:drug effects; D015337:Multicenter Studies as Topic; D009640:Norethindrone / Q000494:pharmacology; D009644:Norgestrel / Q000494:pharmacology; D011897:Random Allocation
D003276:Contraceptives, Oral; D003277:Contraceptives, Oral, Combined; D003279:Contraceptives, Oral, Sequential; D004338:Drug Combinations; C020416:norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination; D009640:Norethindrone