Relationship Between the Menstrual Cycle and Heart Disease in Women
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 40 |
| Updated: | 11/8/2014 |
| Start Date: | February 2012 |
| End Date: | December 2012 |
| Contact: | Jeffrey T Jensen, MD, MPH |
| Email: | jensenje@ohsu.edu |
| Phone: | 503-494-0111 |
Identification of the Menstrual Cycle-Associated Factors That Modulate Circulating Lipid Levels in Premenopausal Women
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.
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.
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.
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.
Inclusion Criteria:
- Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles
- 21-40 years of age
- BMI > 18, < 30
- Serum P4 > 9 ng/ml on single sample collected between days 18-25 of self-reported
menstrual cycle
- Flexible schedule allowing morning blood draws on less than 48 hour notice
- In good general health
- Commit to remain on stable diet during study period (no changes to normal dietary
habits)
- Commit to using non-hormonal contraceptive methods during study period except those
prescribed in the experimental protocol
- No objections to taking study drugs
Exclusion Criteria:
- Oral contraceptive use or other hormone supplement within the preceding 2 months
- Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera®)
- Contraindications to study drugs
- Current or past pregnancy within the previous 6 months or currently trying to
conceive
- Desiring to conceive in the next 8 months
- Breastfeeding in the past 2 months
- Diagnosed Diabetes or Metabolic Syndrome
- Current or previous use of cholesterol lowering drugs within the preceding 12 months
- Diagnosed Polycystic Ovary Syndrome
- History of, or self-reported, substance abuse
- Smoker
- Previous infertility treatment excluding male factor issues
- Use of an investigational drug within the past 2 months
We found this trial at
1
site
Portland, Oregon 97239
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