Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)

Last updated: March 18, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amenorrhea

Treatment

N/A

Clinical Study ID

NCT05629377
22-006348
R01HD106096
  • Ages 18-40
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Secondary amenorrhea of 3 or more consecutive months duration

  • Include the screening hormones (eg, estradiol (E2) < 50 pg/ml, Follicle-StimulatingHormone (FSH) <10 mIU/ml, and Luteinizing Hormone (LH) < 10mIU/ml and otherHA-defining hormones); or clinical diagnosis of HA by medical providers.

  • Pre-menopause status.

  • Able to give informed consent.

Exclusion

Exclusion Criteria:

  • A diagnosis for secondary amenorrhea including prolactinoma, Polycystic OvarySyndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection orinfarction

  • Pregnancy

  • Psychotropic/illicit drug use

  • Mental/neurological/major psychological disorders (other than depression andanxiety).

  • Parturition/lactating in the last 6-12 months.

Study Design

Total Participants: 90
Study Start date:
January 17, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

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