Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
Launched by CEDARS-SINAI MEDICAL CENTER · Jan 10, 2017
Trial Information
Current as of June 18, 2025
Completed
Keywords
ClinConnect Summary
Study Aims:
1. To test the hypothesis premenopausal HypoE (women with FHA) is associated with pre-clinical CVD as determined by reductions in vascular endothelial function.
2. To test the hypothesis premenopausal HypoE (women with FHA) is associated with increased immune-mediated inflammation.
3. To test the hypothesis whether estrogen replacement can reduce inflammation and improve vascular endothelial function in premenopausal HypoE women (women with FHA).
In a randomized, double-blind placebo-controlled trial in premenopausal HypoE women (women with FHA) the investigators will test 12 ...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- For premenopausal Hypo E and normal control women, inclusions include:
- • Premenopausal currently not on hormone therapy,
- • English speaking (for the purposes of complete psychosocial assessment)
- • able to give informed consent
- • a gynecological age (age since menarche) \> 10 and \< 25 years, and chronological age \> 18 years
- • Within 90-110% of ideal body weight as determined by the 1983 Metropolitan Height and weight table for women
- • 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
- For recently menopausal women inclusions include:
- • Follicle stimulating hormones (FSH) \>30 and 12 months of amenorrhea, within 3 years of final menstrual period with natural menopausal not on hormone therapy
- • English speaking
- • Able to give informed consent
- • Within 90-110% of ideal body weight
- Exclusion Criteria:
- For premenopausal Hypo E and normal control women exclusions include:
- • Smoking
- • Hypertension
- • Hyperlipidemia
- • Diabetes
- • Medications including psychotropic or illicit drugs, medical, neurological
- • Ophthalmologic disease except acuity problems
- • Major Axis I disorder other than depression
- • Pregnancy in the last 12 months and/or lactating in the last 6 months
- • Current use of hormone contraceptive or any estrogen or progestin therapy
- For HypoE women, exclusion criteria include:
- • - Allergy to adhesive or tape
- For recently menopausal women exclusions also include:
- • Previous or current use of hormone therapy, estrogen or progestin
- • Surgical or chemotherapy induced menopause
- • Premature ovarian failure
About Cedars Sinai Medical Center
Cedars-Sinai Medical Center is a renowned nonprofit academic medical center located in Los Angeles, California, recognized for its commitment to patient care, research, and education. As a leading institution in clinical trials, Cedars-Sinai harnesses innovative approaches to advance medical knowledge and improve treatment outcomes across various specialties. With a multidisciplinary team of experts, state-of-the-art facilities, and a patient-centered approach, Cedars-Sinai actively contributes to the development of novel therapies and interventions, ensuring the highest standards of clinical research while prioritizing patient safety and ethical considerations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Patients applied
Trial Officials
Chrisandra Shufelt, MD
Principal Investigator
Cedars-Sinai Medical Center
Noel Bairey-Merz, MD
Study Director
Cedars-Sinai Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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