Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Contact Information
Primary
Chrisandra Shufelt, MD
Shufelt.Chrisandra@mayo.edu
904-953-2160
Time Frame
Start Date: 2023-01-17
Estimated Completion Date: 2026-05
Participants
Target number of participants: 90
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov