Treatment for Atherogenesis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cedars-Sinai Barbra Streisand Women's Heart Center, Los Angeles, CA
Atherogenesis+6 More
Eligibility
18 - 65
Female
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Study Summary

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

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Eligible Conditions

  • Atherogenesis
  • Cardiovascular Disease (CVD)
  • hypoestrogenism
  • Hypothalamic Amenorrhea

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Atherogenesis

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 11 secondary outcomes in patients with Atherogenesis. Measurement will happen over the course of Baseline, week 6, 12, and 14 on trial.

Baseline
DEXA Scan
Week 6
Anxiety
Depression
Hormone levels
Quality of life (questionnaire)
Rate of change of distal common carotid artery, Carotid Intima-Media Thickness (cIMT)
Rate of change of peripheral arterial tonometry (PAT)
Rate of change of pulse wave analysis
Rate of change of pulse wave velocity
Serum Inflammatory Markers
Sleep changes
Stress

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Atherogenesis

Trial Design

2 Treatment Groups

17Beta Estradiol, Progesterone
1 of 2
Transdermal Placebo Patch, Placebo Pill
1 of 2
Active Control
Non-Treatment Group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

17Beta Estradiol, Progesterone17Beta Estradiol (0.1mg/day) , Progesterone (200mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 200mg is a peanut based product
Transdermal Placebo Patch, Placebo PillPlacebo Transdermal Patch, Placebo Pill

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 6, 12, and 14 on trial
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, week 6, 12, and 14 on trial for reporting.

Who is running the study

Principal Investigator
C. S.
Chrisandra Shufelt, Associate Director, Barbra Streisand Women's Heart Center
Cedars-Sinai Medical Center

Closest Location

Cedars-Sinai Barbra Streisand Women's Heart Center - Los Angeles, CA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The purpose of this assessment is to determine the speaker's ability to function in English. show original
, or surgical removal of ovaries If someone has a FSH level of greater than 30 and has been amenorrheic for 12 months, has experienced natural menopause within the past 3 years, or has had their ovaries surgically removed, then they are considered to have gone through early menopause. show original
The ideal body weight for women is between 90 and 110% of the weight listed in the 1983 Metropolitan height and weight table. show original
All participants with hypothalamic amenorrhea will be diagnosed based on exclusion of other etiologies for their amenorrhea, including pregnancy, thyroid dysfunction, hyperprolactinemia, premature ovarian insufficiency, and polycystic ovary disease
Within 90-110% of what is considered an ideal body weight. show original
Some women currently not on hormone therapy (HT) are premenopausal. show original
able to give informed consent
The individual is at least 10 years old since menarche, but has not yet reached 25 years old; and the person is at least 18 years old in chronological age. show original
English speaking
The patient is able to provide consent that is based on adequate information. show original

Patient Q&A Section

What causes cardiovascular diseases?

"The development of CVD is an interaction of the individual's profile of genetic vulnerability and exposure to environmental factors, which may act synergistically or operate independently." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cardiovascular diseases?

"It is important for patients, physicians and policy makers to become acquainted with the latest research in cardiovascular diseases. The latest scientific evidence on cardiovascular diseases from scientific research supports evidence-based interventions." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cardiovascular diseases?

"For general population with no previous history of CVD the leading CV medications/interventions are aspirin, and statins while those without known CVD are more inclined toward anti-platelet medications. Also there is a high prevalence of aspirin and CV-directed therapies in patients with CVD." - Anonymous Online Contributor

Unverified Answer

What are the signs of cardiovascular diseases?

"Some early signs of cardiovascular disease include the abnormal heart beat, dizziness or shortness of breath. Other early signs of heart disease include pain in the chest or chest pain with exertion.\n" - Anonymous Online Contributor

Unverified Answer

How many people get cardiovascular diseases a year in the United States?

"Cardiovascular Disease Prevention programmes aim at reducing the risk of major cardiovascular illnesses and total morbidity and mortality in the population. By identifying those populations and individuals at higher risk, cardiovascular disease prevention programmes should focus on the most important risk factors." - Anonymous Online Contributor

Unverified Answer

What is cardiovascular diseases?

"The current study indicates that cardiovascular diseases may be an aggravating factor in women with the metabolic syndrome. It is recommended that healthcare providers take note of the cardiovascular risk factors in women with metabolic syndrome in order to enhance their cardiovascular risk reduction strategies. More research is needed, especially regarding associations with metabolic syndrome and cardiovascular disease in women." - Anonymous Online Contributor

Unverified Answer

Can cardiovascular diseases be cured?

"This is the first meta-analysis to provide evidence that can heal chronic diseases of the cardiovascular system. While a full cure cannot be achieved, it seems that some chronic diseases can be controlled. In a recent study, findings could have significant impact on the design and implementation of future clinical trials." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cardiovascular diseases?

"There appears to be a trend that is associated with more advanced disease in people with a history of CVD. For example, men tend to have a higher risk of CVD even if they are younger and women have a lower risk. Although this trend is most pronounced early in life, we are all at risk for cardiovascular disease at any age." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"It is clear from this research that treatment and prognosis for patients with [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) are currently very different. Although the prognosis is better for patients diagnosed when the disease is minimal, treatment and options remain very limited and, even, are often unsuccessful. This has created a need for clinical research to investigate the causes and effects of myeloma. Future research should be directed at improving outcomes from myeloma." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"Patients undergoing therapy can experience some common side effects that are dose dependent and are related directly to the treatment itself. [Fever, loss of appetite, diarrhea, joint pain, chest discomfort and/or shortness of breath are a few of the common side effects of treatment.] These common side effects can be mitigated by seeking medical advice immediately after starting therapy. You can find side effects by using Power to search by treatment and side effects." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"A number of additional relevant investigations have been performed with the aim of detecting potential benefits such as reducing the risk of developing future cardiovascular disease. Although many of these studies have been conducted after the initial trial was concluded, the results of their primary investigations still need to be interpreted and assessed for their clinical relevance." - Anonymous Online Contributor

Unverified Answer

Does cardiovascular diseases run in families?

"Genetic counseling is a crucial part of medical genetics and family health. The incidence of common CVDs and their genetic loci may vary, depending on ethnicity, gender and geographic distribution. This is one of the first studies to explore the association of CVDs and genetic loci." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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