Evaluation of four different contraceptive vaginal rings: steroid serum levels, luteal activity, bleeding control and lipid profiles.
Four different models of contraceptive vaginal rings were tested during three cycles for luteal activity, bleeding control, plasma lipoproteins and serum levels of the contraceptive steroids. Two progestins, levonorgestrel acetate (LNGA) and ST 1435, alone or in combination with ethynyl-estradiol (EE) were tested. The rings released 100 ug/day of the progestins and 30 ug/day of EE. Luteal activity was detected among users of the progestin-only rings: 4 of 8 cycles with ST 1435 and 2 of 10 with LNGA. Only one of the 18 cycles studied with the two combined rings showed luteal activity, but the measurement of contraceptive steroid in plasma suggested that this subject delayed reinsertion of the ring for about one week in that particular cycle. Breakthrough bleeding was observed in 12 of 30 cycles of use of the progestin-only rings, and in only 2 of 27 cycles with the combined models. No significant changes in total cholesterol or its HDL-fraction were observed. However, the only reduction observed in HDL-cholesterol was among users of the LNGA-only ring. It is concluded that the two combined CVR models offer good possibilities of high effectiveness and bleeding control and merit further development.
Alvarez-Sanchez
F
F
Department of Biomedical Research, Profamilia Santo Domingo, Dominican Republic.
Brache
V
V
Jackanicz
T
T
Faundes
A
A
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D003271:Contraceptive Agents, Female / Q000097:blood / Q000494:pharmacology; D003274:Contraceptive Devices, Female / Q000009:adverse effects; D004967:Estrogens / Q000097:blood; D004997:Ethinyl Estradiol / Q000097:blood / Q000494:pharmacology; D005069:Evaluation Studies as Topic; D005260:Female; D012739:Gonadal Steroid Hormones / Q000097:blood*; D006801:Humans; D016912:Levonorgestrel / Q000097:blood / Q000494:pharmacology; D008074:Lipoproteins / Q000097:blood*; D008597:Menstrual Cycle / Q000187:drug effects*; D008598:Menstruation / Q000187:drug effects*; D009653:Norprogesterones / Q000097:blood / Q000494:pharmacology; D011374:Progesterone / Q000097:blood; D011863:Radioimmunoassay
D003271:Contraceptive Agents, Female; D004967:Estrogens; D012739:Gonadal Steroid Hormones; D008074:Lipoproteins; D009653:Norprogesterones; D004997:Ethinyl Estradiol; D011374:Progesterone; D016912:Levonorgestrel; C029167:ST 1435