drugset / Trial / NCT01590849
Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
Non-randomizedParallel-groupSingle-blind
Summary
The use of combined oral contraceptives has been associated with increased risk of adverse cardiovascular events. The exact mechanism by which these drugs exert this influence is uncertain. It is possible that changes in autonomic nervous system are involved. The objective of these study was to evaluate the effect of the use of a contraceptive containing 20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous system in healthy women. Few studies have been conducted in the field of hormonal contraception and evaluation of the autonomic nervous system work and no prospective, controlled study was published so far. These study will be the first.
Timeline
- Start
- 2011-01
- Primary completion
- 2012-05
- Completion
- —
Publications
- Background Carter JR, Klein JC, Schwartz CE. Effects of oral contraceptives on sympathetic nerve activity during orthostatic stress in young, healthy women. Am J Physiol Regul Integr Comp Physiol. 2010 Jan;298(1):R9-R14. doi: 10.1152/ajpregu.00554.2009. Epub 2009 Oct 14.
- Background Minson CT, Halliwill JR, Young TM, Joyner MJ. Sympathetic activity and baroreflex sensitivity in young women taking oral contraceptives. Circulation. 2000 Sep 26;102(13):1473-6. doi: 10.1161/01.cir.102.13.1473.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | drospirenone | Unknown | 3 mg | Oral |
| Comparator | ethinyl estradiol | Small molecule | 20 ug | Oral |
Indications
No indication recorded.