Using hypothalamic amenorrhea to assess cardiovascular health in women
Official title: Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
Run by Mayo Clinic · NCT05629377 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to see how hypothalamic amenorrhea in women might be connected to heart health and inflammation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05629377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are premenopausal women with secondary amenorrhea lasting three or more consecutive months.
✕Probably not a fit
Patients with secondary amenorrhea due to conditions like prolactinoma, PCOS, or other specified exclusions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pulsatile subcutaneous kisspeptin to trigger ovulation in women with hypothalamic amenorrhea
This trial tests whether two weeks of pulsed subcutaneous kisspeptin can trigger reproductive hormone release and stimulate ovarian follicle growth and egg release in women with hypothalamic amenorrhea.
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Registry for women with early estrogen loss due to hypothalamic amenorrhea
This study is creating a registry to learn more about women who have early estrogen loss from hypothalamic amenorrhea, focusing on their health, lifestyle, and the diversity of this condition.
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This study is trying to see how genetics might be linked to reproductive disorders and conditions like cleft lip and palate to better understand their causes.
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Feasibility of a 10-week self-guided digital program for functional hypothalamic amenorrhea
This pilot test checks whether a 10-week, self-guided web program for FHA is doable and acceptable for women, to pave the way for a larger trial.
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Combining Chinese and Western medicine to restore menstrual cycles in hypothalamic amenorrhea
This program will try a two-step approach—Western medicine to quickly restore menstrual bleeding and traditional Chinese medicine to support long-term hormonal balance—for women with functional hypothalamic amenorrhea.
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Mibavademab for adult women with functional hypothalamic amenorrhea
This trial tests whether the experimental drug mibavademab helps adult women with functional hypothalamic amenorrhea make the hormones needed to resume ovulation and menstrual cycles.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.