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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Relationship Between the Menstrual Cycle and Heart Disease in Women

NCTNCT01546454 (opens ClinicalTrials.gov in a new tab)Other idIRB8023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
5 participants (actual)
Sponsor
Oregon Health and Science University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Feb 2012
Primary completion
Jun 2012
Completion
Jan 2013
First posted
7 Mar 2012 (estimated)
Last update posted
22 Mar 2017
Conditions
Coronary Heart Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. N/A

    Relationship Between the Menstrual Cycle and Heart Disease in Women

    NCT01546454

    Feb 2012 to Jan 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Ethinyl Estradiol-Levonorgestrel combinationDrug
  • leuprolide acetateDrug
  • EstradiolDrug
  • ProgesteroneDrug

Arms3

  • Experimental

    Non-steroidal effects

    Natural menstrual cycle versus Estrogen/Progesterone replacement cycle. Interventions include leuprolide acetate to induce hypogonadism and estradiol and progesterone to replace hormone levels.

  • Experimental

    Contraceptive effects

    Oral contraceptive cycle versus Eligard treatment. Interventions include ethinyl estradiol-levonorgestrel combination and leuprolide acetate.

  • Experimental

    Steroid effects

    Estrogen/Progesterone replacement cycle versus Eligard treatment. Interventions include leuprolide acetate, estradiol, and progesterone.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total to HDL Cholesterol Ratio

    Time frame · Entire Study

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Entire Study

Total to HDL Cholesterol Ratio

GroupValue (Total to HDL Cholesterol Ratio)
Non-steroidal Effects0.146
Contraceptive Effects0.148
Steroid Effects-0.89

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
All Study Participants–0 / 40 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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