Relationship Between the Menstrual Cycle and Heart Disease in Women
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Heart Disease |
Drug: Ethinyl Estradiol-Levonorgestrel combination Drug: leuprolide acetate Drug: Estradiol Drug: Progesterone |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Identification of the Menstrual Cycle-Associated Factors That Modulate Circulating Lipid Levels in Premenopausal Women |
- Change from baseline in total cholesterol to high density lipoprotein cholesterol ratio following ovarian suppression and steroid replacement [ Time Frame: Baseline month and one month of ovarian suppression with steroid replacement ] [ Designated as safety issue: No ]
- Change from baseline in total cholesterol to high density lipoprotein cholesterol ratio after estradiol and progesterone replacement [ Time Frame: 3 week baseline and 4 weeks of estradiol and progesterone replacement ] [ Designated as safety issue: No ]
- Change from baseline in total cholesterol to high density lipoprotein cholesterol ratio after monophasic hormonal oral contraceptive use [ Time Frame: Baseline month and 3 weeks of oral contraceptive use ] [ Designated as safety issue: No ]
- Change from baseline in serum low density lipoprotein cholesterol following ovarian suppression and steroid replacement [ Time Frame: Baseline month and one month of ovarian suppression with steroid replacement ] [ Designated as safety issue: No ]
- Change from baseline in serum low density lipoprotein cholesterol after estradiol and progesterone replacement [ Time Frame: 3 week baseline and 4 weeks of estradiol and progesterone replacement ] [ Designated as safety issue: No ]
- Change from baseline in serum low density lipoprotein cholesterol after monophasic combined hormonal oral contraceptive use [ Time Frame: One month baseline and 3 weeks of oral contraceptive use ] [ Designated as safety issue: No ]
- Change from baseline in serum high density lipoprotein cholesterol following ovarian suppression and steroid replacement [ Time Frame: Baseline month and one month of ovarian suppression with steroid replacement ] [ Designated as safety issue: No ]
- Change from baseline in serum high density lipoprotein cholesterol after estradiol and progesterone replacement [ Time Frame: 3 week baseline and 4 weeks of estradiol and progesterone replacement ] [ Designated as safety issue: No ]
- Change from baseline in serum high density lipoprotein cholesterol after monophasic combined hormonal oral contraceptive use [ Time Frame: One month baseline and 3 weeks of oral contraceptive use ] [ Designated as safety issue: No ]
- Change from baseline in serum triglycerides following ovarian suppression and steroid replacement [ Time Frame: Baseline month and one month of ovarian suppression with steroid replacement ] [ Designated as safety issue: No ]
- Change from baseline in serum triglycerides after estradiol and progesterone replacement [ Time Frame: 3 week baseline and 4 weeks of estradiol and progesterone replacement ] [ Designated as safety issue: No ]
- Change from baseline in serum triglycerides after monophasic combined hormonal oral contraceptive use [ Time Frame: One month baseline and 3 weeks of oral contraceptive use ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
-
Drug: Ethinyl Estradiol-Levonorgestrel combination
- Portia 21
- Portia 28
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.
Eligibility| Ages Eligible for Study: | 21 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Jeffrey T Jensen, MD, MPH | 503-494-0111 | jensenje@ohsu.edu |
| Contact: Randy L Bogan, PhD | 503-614-3751 | boganr@ohsu.edu |
| United States, Oregon | |
| Oregon Health & Sciences University, Department of Obstetrics and Gynecology, Women's Health Research Unit | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Principal Investigator: Jeffrey T Jensen, MD, MPH | |
| Sub-Investigator: Randy L Bogan, PhD | |
| Principal Investigator: | Jeffrey T Jensen, MD, MPH | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | Jeffrey Jensen, Director, Women's Health Research Unit, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01546454 History of Changes |
| Other Study ID Numbers: | IRB8023 |
| Study First Received: | February 22, 2012 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Premenopausal women coronary heart disease menstrual cycle lipids |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Estradiol Polyestradiol phosphate Ethinyl Estradiol Progesterone Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate |
Levonorgestrel Ethinyl estradiol, levonorgestrel drug combination Leuprolide Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral Progestins |
ClinicalTrials.gov processed this record on May 22, 2013