MedTrace Logo

Relationship Between the Menstrual Cycle and Heart Disease in Women

NCT01546454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-03-22

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Ethinyl Estradiol-Levonorgestrel combination

0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days

DRUG

leuprolide acetate

single 22.5 mg subcutaneous depot suspension

DRUG

Estradiol

0.05 to 0.3 mg transdermal daily for 26 days

DRUG

Progesterone

50 to 100 mg vaginal suppositories twice daily for 13 days

Sponsors & Collaborators

  • Medical Research Foundation, Oregon

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jeffrey T Jensen, MD, MPH · Oregon Health and Science University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-06-30
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01546454 on ClinicalTrials.gov