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Comparison of the impact of vaginal and oral administration of combined hormonal contraceptives on hepatic proteins sensitive to estrogen
- Publication Year :
- 2007
-
Abstract
- Objective: We evaluated the effects of a new combined hormonal contraceptive vaginal ring (CVR) delivering the nonandrogenic progestin Nestorone® (NES) and ethinyl estradiol (EE) on several key estrogen-sensitive hepatic proteins that may be markers for the risk of arterial or venous disease events and on blood pressure (BP). Because the pharmacologic androgenicity of the progestin in these formulations influences the hepatic impact of EE, we selected an oral contraceptive (OC) delivering the androgenic progestin levonorgestrel (LNG) and EE as the comparator. We also investigated the effect of delivery route, which is known to modify the hepatic effects of estradiol, but has not been widely studied with EE. Study Methods: Women, aged 18-34 years, with no contraindications to the use of combined OCs, were randomized to three cycles of treatment with a CVR delivering NES/EE (150/15 μg/day) or a combined OC providing LNG and EE (150/30 μg per tablet). Each cycle consisted of 21 days of active treatment, followed by 7 days without treatment. During the last weeks of the pretreatment and third treatment cycles, blood samples were obtained for determinations of plasma concentrations of angiotensinogen, an estrogen-sensitive hepatic protein, and serum concentrations of sex hormone-binding globulin (SHBG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) and estrogen- and androgen-sensitive proteins. BP was also measured. Results: Of 47 women randomized, 45 completed the study (CVR: 23; OC: 22). Within-group comparisons over time by repeated-measure analysis of variance demonstrated statistically significant changes over time with both treatments for all hepatic proteins (p
- Subjects :
- systolic blood pressure
Biomedical Research
vein disease
Angiotensinogen
Ethinyl Estradiol
low density lipoprotein cholesterol
high density lipoprotein cholesterol
Sex Hormone-Binding Globulin
estrogen
Combined
adult
hormonal contraception
article
contraceptive agent
clinical trial
Contraceptives
Blood Proteins
sex hormone binding globulin
female
Cholesterol
liver protein
triacylglycerol
hormones, hormone substitutes, and hormone antagonists
Norprogesterones
Oral
ethinylestradiol plus norelgestromin
Adolescent
HDL
Contraceptive vaginal ring
Levonorgestrel
artery disease
menstrual cycle
ethinylestradiol plus levonorgestrel
LDL
elcometrine
Contraceptive Agents
Nestorone®
Humans
controlled study
human
normal human
SHBG
intermethod comparison
Triglycerides
controlled clinical trial
vagina ring
diastolic blood pressure
drug blood level
randomized controlled trial
Contraceptive Devices
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.dris...00893..3bf79db73c8b2bb036f67cc2751f878d