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NCT05967819 · ClinicalTrials.gov registry record · NA
Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
A NA study of Amenorrhea Secondary, sponsored by University of Colorado, Colorado Springs.
- Recruiting
- Registry status
- NA
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT05967819: Recruiting NA study of Amenorrhea Secondary, sponsored by University of Colorado, Colorado Springs.
NCT05967819 is a NA study of Amenorrhea Secondary that is actively recruiting participants, run by University of Colorado, Colorado Springs. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05967819, a NA study of Amenorrhea Secondary, is actively recruiting participants, sponsored by University of Colorado, Colorado Springs.
- RECRUITING
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists. The main questions it aims to answer are: * Does the implementation of exercise or psychosocial stress effect circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? * Is there an additive effect of combined exercise and psychosocial on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? Participants will be asked to do the following over the \~3 month enrollment period: * attend a laboratory visit at the beginning and end of the study to have their resting metabolic rate, aerobic fitness, and body composition tested * monitor their menstrual cycle length, daily perceived stress levels, physical activity, and diet each month * provide several urine and saliva samples each month * either maintain their usual physical activity and lifestyle habits (control group), increase the duration of their weekly running or cycling mileage by 30% (exercise stress group), complete cognitive function tasks designed to be stressful (psychosocial stress group), or increase the duration of their weekly running or cycling mileage by 30% and complete cognitive function tasks designed to be stressful (exercise + psychosocial stress group) during the final month of enrollment. Researchers will compare control, exercise stress, psychosocial stress, and exercise + psychosocial stress groups to see if there is an effect on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length.
Primary Outcome
ng/mL
Conditions Studied
Interventions
- BEHAVIORAL Exercise Stress
- BEHAVIORAL Psychosocial Stress
Study Locations (1)
Colorado
- University of Colorado Colorado Springs - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-08-09 |
| Est. Completion | 2026-08-30 |
| Phase | NA |
What NCT05967819 shows while recruiting
NCT05967819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Amenorrhea Secondary appearing as the primary indexed condition, and to 2 interventions - of which Exercise Stress is the first listed.
NCT05967819 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05967819 about?
NCT05967819 is a clinical study titled "Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women". The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists. The main questions it aims to answer are: * Does the implementation of exercise or psychosocial stress effect circ...
What is the current status of trial NCT05967819?
This trial is currently recruiting. It is a NA study. The enrollment target is 54 participants. The study started on 2023-08-09. Estimated completion is 2026-08-30.
What conditions does trial NCT05967819 study?
This clinical trial studies the following conditions: Amenorrhea Secondary.
What interventions are being tested in trial NCT05967819?
The interventions under investigation include: Exercise Stress (BEHAVIORAL), Psychosocial Stress (BEHAVIORAL).
Who is sponsoring clinical trial NCT05967819?
This trial is sponsored by University of Colorado, Colorado Springs, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05967819 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05967819's enrollment target sits among peer trials
54 1268th of 2000 higher than 730 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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