Using hypothalamic amenorrhea to assess cardiovascular health in women
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
This study is trying to see how hypothalamic amenorrhea in women might be connected to heart health and inflammation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05629377 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between hypothalamic amenorrhea (HA) and cardiovascular health in women. It focuses on women experiencing secondary amenorrhea for three or more consecutive months, utilizing remote patient monitoring and questionnaires to gather data on various HA phenotypes. The study aims to identify which specific HA characteristics are linked to preclinical cardiovascular disease and inflammation, thereby using HA as a potential marker for fertility status and cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women with secondary amenorrhea lasting three or more consecutive months.
Not a fit: Patients with secondary amenorrhea due to conditions like prolactinoma, PCOS, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the cardiovascular risks associated with hypothalamic amenorrhea, potentially guiding better health management for affected women.
How similar studies have performed: While the specific approach of using HA as a marker for cardiovascular health is novel, related studies have indicated a connection between reproductive health and cardiovascular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Secondary amenorrhea of 3 or more consecutive months duration * Include the screening hormones (eg, estradiol (E2) \< 50 pg/ml, Follicle-Stimulating Hormone (FSH) \<10 mIU/ml, and Luteinizing Hormone (LH) \< 10mIU/ml and other HA-defining hormones); or clinical diagnosis of HA by medical providers. * Pre-menopause status. * Able to give informed consent. Exclusion Criteria: * A diagnosis for secondary amenorrhea including prolactinoma, Polycystic Ovary Syndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection or infarction * Pregnancy * Psychotropic/illicit drug use * Mental/neurological/major psychological disorders (other than depression and anxiety). * Parturition/lactating in the last 6-12 months.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Chrisandra Shufelt, MD — Mayo Clinic
- Study coordinator: Chrisandra Shufelt, MD
- Email: Shufelt.Chrisandra@mayo.edu
- Phone: 904-953-2160
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.