drugset / Trial / NCT01546454

Relationship Between the Menstrual Cycle and Heart Disease in Women

NCT01546454

Non-randomizedSingle-groupOpen-labelBasic science

Summary

Women who have regular menstrual cycles have a lower risk of heart disease than men of the same age or women who no longer have menstrual cycles. The purpose of this study is to help determine why the menstrual cycle causes a lower risk of heart disease. The investigators believe that the hormones (estradiol and progesterone) produced during the menstrual cycle, as well as the normal processes occurring in the follicle and corpus luteum (transformed follicle), change levels of "good" and "bad" cholesterol in the blood-stream. These levels of good and bad cholesterol are an important risk factor for heart disease. Therefore, our goal is to determine what effects each of these factors (estradiol, progesterone, follicle, corpus luteum) have on the levels of good and bad cholesterol in the woman's bloodstream. As many women take birth control pills, which contain synthetic forms of estradiol and progesterone that block ovulation and development of a corpus luteum, the investigators also want to determine what effect one common type of birth control pill has on levels of good and bad cholesterol.

Timeline

Start
2012-02
Primary completion
2012-06
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.05 mg Other
Subject Estradiol Other / unclassified 0.3 mg Other
Subject Leuprolide Other / unclassified 22.5 mg Subcutaneous
Subject Levonorgestrel Small molecule 0.15 mg Oral
Subject Progesterone Other / unclassified 50 mg Other
Subject Progesterone Other / unclassified 100 mg Other
Subject ethinyl estradiol Small molecule 0.03 mg Oral