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Physical and Psychosocial Stress for Amenorrhea (FHA Trial)
N/A
Recruiting
Research Sponsored by University of Colorado, Colorado Springs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
FHA Trial Summary
This trial will explore how exercise and psychosocial stress can affect menstrual cycle irregularities in female runners.
Who is the study for?
This trial is for female runners and cyclists who can complete a 5-km race in under 25 minutes, have regular menstrual cycles every 21 to 35 days, haven't used hormonal contraceptives or been pregnant/breastfeeding for the past six months, exercise regularly, and don't have metabolic diseases or menstrual disorders.Check my eligibility
What is being tested?
The study examines how increased physical activity and stress affect reproductive hormones and menstrual cycle length. Women will be divided into groups: some maintain their routine while others add more exercise or stressful cognitive tasks to see if these changes impact hormone levels and menstruation.See study design
What are the potential side effects?
Potential side effects are not explicitly mentioned but may include changes in menstrual patterns, stress-related symptoms due to increased psychosocial challenges, fatigue from additional exercise, and possible psychological impacts of altered hormone levels.
FHA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Menstrual cycle length
Urinary estrone-3-glucuronide (E3G)
Urinary luteinizing hormone (LH)
+1 moreFHA Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Psychosocial StressExperimental Treatment1 Intervention
Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits.
Group II: Exercise StressExperimental Treatment1 Intervention
The duration of participant's weekly running or cycling mileage will be increased by 30% while intensity is maintained.
Group III: Exercise + Psychosocial StressExperimental Treatment2 Interventions
Participants will be asked to complete cognitive function tasks designed to be stressful while the duration of their weekly running or cycling mileage is increased by 30% and intensity maintained.
Group IV: ControlActive Control1 Intervention
Participants will be asked to maintain their usual physical activity and lifestyle habits.
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Who is running the clinical trial?
University of Colorado, Colorado SpringsLead Sponsor
15 Previous Clinical Trials
4,711 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed menstrual cycle disorder.I haven't used hormonal birth control in the last 6 months.I have a major heart, lung, or muscle/bone condition.I have never been diagnosed with any menstrual cycle disorders.I have never been diagnosed with a metabolic disease.I have been diagnosed with a metabolic disease like diabetes or thyroid issues.I am able to follow all medical instructions and procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Psychosocial Stress
- Group 2: Control
- Group 3: Exercise Stress
- Group 4: Exercise + Psychosocial Stress
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can geriatric patients participate in this experimental program?
"This trial requires all participants to be between 18 and 35 years old, in accordance with the pre-determined eligibility criteria."
Answered by AI
How can I participate in this clinical research study?
"To qualify for enrollment in this medical trial, potential participants must have the absence of periods and be between 18 to 35 years old. 54 candidates are needed to complete the study."
Answered by AI
How many participants are currently accepted in this medical experiment?
"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial, which was initially posted on August 1st 2023, is currently recruiting patients. The study requires 54 participants from a single location to complete it."
Answered by AI
Is recruitment for this research experiment still ongoing?
"According to the details on clinicaltrials.gov, this study is currently seeking enrollees. The recruitment process began on August 1st 2023 and was recently updated on July 21st 2023."
Answered by AI
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