CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
Ethinyl Estradiol-Levonorgestrel combination +3 moredrug
Likely dose
Ethinyl Estradiol-Levonorgestrel combination 0.03 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01546454
NCT01546454N/ACompleted

Identification of the Menstrual Cycle-Associated Factors That Modulate Circulating Lipid Levels in Premenopausal Women

Oregon Health and Science University·interventional·Posted Mar 7, 2012·Updated Mar 22, 2017

In Brief

A clinical study evaluating Ethinyl Estradiol-Levonorgestrel combination, leuprolide acetate, and 2 other interventions for Coronary Heart Disease. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.3 years ago

Interventions

Ethinyl Estradiol-Levonorgestrel combinationdrug

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

leuprolide acetatedrug

single 22.5 mg subcutaneous depot suspension

Estradioldrug

0.05 to 0.3 mg transdermal daily for 26 days

Progesteronedrug

50 to 100 mg vaginal suppositories twice daily for 13 days