Impact of early menopause on blood pressure regulation in women
Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
This study is trying to see how early menopause affects blood pressure control in women aged 35 to 70 by comparing those who went through menopause early with those who haven’t.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04439370 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how premature and early menopause affects blood pressure regulation in women aged 35 to 70. It aims to identify the mechanisms behind autonomic dysregulation of blood pressure by comparing younger women who have experienced early menopause with age-matched premenopausal women, as well as older women who have been menopausal for over ten years with those who entered menopause at a typical age. The study employs microneurography to measure muscle sympathetic nerve activity, baroreflex sensitivity testing, and other assessments to explore these relationships.
Who should consider this trial
Good fit: Ideal candidates include women aged 35-49 who have experienced premature menopause or women aged 50-70 who have undergone early menopause.
Not a fit: Patients who are currently using tobacco, have diabetes, asthma, or significant cardiovascular or neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of blood pressure issues in women experiencing early menopause.
How similar studies have performed: While there is ongoing research in this area, this specific approach to studying the effects of early menopause on blood pressure regulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 35-49 or 50-70 years of age who experienced premature (\<40) or early (≤45) menopause * Premenopausal 35-49 years of age * Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old * Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of \>30 mIU/mL Exclusion Criteria: * Current nicotine/tobacco use within the past six months * Are diabetic or asthmatic * Have diagnosed significant carotid stenosis * Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury. * Have existing metabolic or endocrine abnormities * Take any heart/blood pressure medications that are determined to interfere with study outcomes * IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes * Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study * Are pregnant or breastfeeding
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Manda Keller-Ross, PhD, DPT, PT
- Email: kell0529@umn.edu
- Phone: 612-625-3175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.