Relationship Between the Menstrual Cycle and Heart Disease in Women
Identification of the Menstrual Cycle-Associated Factors That Modulate Circulating Lipid Levels in Premenopausal Women
1 other identifier
interventional
5
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
October 23, 2014
CompletedMarch 22, 2017
February 1, 2017
4 months
February 22, 2012
April 11, 2014
February 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total to HDL Cholesterol Ratio
Entire Study
Study Arms (3)
Non-steroidal effects
EXPERIMENTALNatural menstrual cycle versus Estrogen/Progesterone replacement cycle. Interventions include leuprolide acetate to induce hypogonadism and estradiol and progesterone to replace hormone levels.
Contraceptive effects
EXPERIMENTALOral contraceptive cycle versus Eligard treatment. Interventions include ethinyl estradiol-levonorgestrel combination and leuprolide acetate.
Steroid effects
EXPERIMENTALEstrogen/Progesterone replacement cycle versus Eligard treatment. Interventions include leuprolide acetate, estradiol, and progesterone.
Interventions
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
Eligibility Criteria
You may qualify if:
- Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Sciences University, Department of Obstetrics and Gynecology, Women's Health Research Unit
Portland, Oregon, 97239-3098, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Randy Bogan
- Organization
- University of Arizona
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey T Jensen, MD, MPH
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Women's Health Research Unit
Study Record Dates
First Submitted
February 22, 2012
First Posted
March 7, 2012
Study Start
February 1, 2012
Primary Completion
June 1, 2012
Study Completion
January 1, 2013
Last Updated
March 22, 2017
Results First Posted
October 23, 2014
Record last verified: 2017-02