Relationship Between the Menstrual Cycle and Heart Disease in Women
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

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.
    

Detailed description: 
      Premenopausal women are at a lower age-adjusted risk of coronary heart disease (CHD) than men
      or postmenopausal women. This decreased risk of CHD is likely due, in part, to the more
      favorable lipid profile observed in premenopausal women. The menstrual cycle is associated
      with the ovarian processes of follicular growth and ovulation, and corpus luteum (CL)
      development, function, and regression. The steroids estrogen (E2) and progesterone (P4) are
      secreted from the follicle and CL, which travel via the bloodstream to elicit their effects
      on target tissues. The production of E2 has been implicated as the menstrual cycle-associated
      factor underlying the favorable lipid profile as it is known to increase atheroprotective
      high density lipoprotein and decrease atherogenic low density lipoprotein. However, other
      factors may play a role such as direct ovarian metabolism of circulating lipids. Furthermore,
      the role of P4 is unclear and there is some evidence that it may inhibit the beneficial
      effects of E2. Therefore, we aim to determine the contributions of ovarian metabolism of
      lipids, independent of the effects of ovarian-derived E2 and P4, to the circulating lipid
      profile in premenopausal women. Also, we will determine the relationship between E2 and P4,
      both natural and synthetic forms found in hormonal oral contraceptives, on circulating
      lipids. With the recent controversial findings of the Women's Health Initiative, further
      evaluation of the factors underlying menstrual cycle protection from CHD is warranted. This
      study may have implications for the management of CHD and the use of hormonal therapies in
      women.
    

Intervention name(s): Ethinyl Estradiol-Levonorgestrel combination; leuprolide acetate; Estradiol; Progesterone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days; single 22.5 mg subcutaneous depot suspension; 0.05 to 0.3 mg transdermal daily for 26 days; 50 to 100 mg vaginal suppositories twice daily for 13 days
Other intervention name(s): Portia 21; Portia 28; Eligard; Vivelle-Dot; First-Progesterone VGS
Intervention MeSH terms: Leuprolide; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Premenopausal women; coronary heart disease; menstrual cycle; lipids