N/A
N=4
Relationship Between the Menstrual Cycle and Heart Disease in Women
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT01546454 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Total to HDL Cholesterol Ratio — 0.146; 0.148; -0.89 Total to HDL Cholesterol Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ethinyl Estradiol-Levonorgestrel combination (Drug); leuprolide acetate (Drug); Estradiol (Drug); Progesterone (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total to HDL Cholesterol Ratio |
0.146; 0.148; -0.89 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles
- 21-40 years of age
- BMI > 18, 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
Data sourced from ClinicalTrials.gov (NCT01546454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.