A contraceptive vaginal ring releasing norethindrone acetate and ethinyl estradiol.
A core design contraceptive vaginal ring (CVR) releasing 650 mcg of norethindrone acetate (NA) and 10, 20, 30 or 65 mcg of ethinyl estradiol (EE) daily was developed and tested in 99 women. The CVR inhibited ovulation well with 30 or 65 mcg EE. Vaginal bleeding was better controlled than in 23 control women using NA/EE oral contraceptives. Side effects were comparable to controls for the 20 and 30 mcg EE CVR. The 65 mcg EE CVR resulted in an unacceptably high level of nausea. The 20 and 30 mcg EE CVR caused an increase in serum HDL cholesterol and triglycerides. Total cholesterol was unchanged. Angiotensinogen and sex hormone binding globulin-binding capacity were increased in a subgroup of the 20 and 30 mcg EE CVR subjects, similar to that of 20 controls using EE/gestodene oral contraceptives. This new CVR offers an excellent contraceptive alternative with the best performance provided by the 30 mcg EE dose.
Ballagh
S A
SA
University of Southern California School of Medicine, Department of Obstetrics and Gynecology, Los Angeles.
Mishell
D R
DR
Lacarra
M
M
Shoupe
D
D
Jackanicz
T M
TM
Eggena
P
P
D000282:Administration, Intravaginal; D000328:Adult; D000804:Angiotensin II / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D003274:Contraceptive Devices, Female / Q000009:adverse effects / Q000592:standards*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000592:standards*; D005260:Female; D006801:Humans; D008183:Luteal Phase / Q000502:physiology; D008597:Menstrual Cycle / Q000502:physiology; D009325:Nausea / Q000139:chemically induced; D009640:Norethindrone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000592:standards; D000077563:Norethindrone Acetate; D012738:Sex Hormone-Binding Globulin / Q000032:analysis; D014280:Triglycerides / Q000097:blood
D008076:Cholesterol, HDL; D003692:Delayed-Action Preparations; D012738:Sex Hormone-Binding Globulin; D014280:Triglycerides; D000804:Angiotensin II; D004997:Ethinyl Estradiol; D000077563:Norethindrone Acetate; D009640:Norethindrone