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NCT05629377 · ClinicalTrials.gov registry record
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)
A clinical trial of Hypothalamic Amenorrhea, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- 90
- Enrollment target
- 1
- Study location
NCT05629377: Recruiting study of Hypothalamic Amenorrhea, sponsored by Mayo Clinic.
NCT05629377 is a study of Hypothalamic Amenorrhea that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 90 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05629377, a study of Hypothalamic Amenorrhea, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- 90 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Duration of HA by month of amenorrhea (absence of menstruation)
Conditions Studied
Study Locations (1)
Florida
- Mayo Clinic Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-01-17 |
| Est. Completion | 2026-05 |
What NCT05629377 shows while recruiting
NCT05629377 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 90 participants, a relatively small participant target.
The record links to 1 condition, with Hypothalamic Amenorrhea appearing as the primary indexed condition, and to 0 interventions.
NCT05629377 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05629377 about?
NCT05629377 is a clinical study titled "Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)". 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 f...
What is the current status of trial NCT05629377?
This trial is currently recruiting. The enrollment target is 90 participants. The study started on 2023-01-17. Estimated completion is 2026-05.
What conditions does trial NCT05629377 study?
This clinical trial studies the following conditions: Hypothalamic Amenorrhea.
Who is sponsoring clinical trial NCT05629377?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05629377 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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