Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women (FHA)

Independent and Synergistic 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 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.

Study Overview

• Status: Recruiting
• Conditions: Amenorrhea Secondary
• Intervention / Treatment: Behavioral: Exercise Stress; Behavioral: Psychosocial Stress

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marissa Baranauskas, PhD; Phone Number: 719-255-4475; Email: mbaranau@uccs.edu
• Study Contact Backup: Name: Kristen Rudd, PhD; Email: krudd@uccs.edu

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Recruiting
      • University of Colorado Colorado Springs
      • Contact: Marissa Baranauskas, PhD; Phone Number: 719-255-4475; Email: mbaranau@uccs.edu
      • Contact: Kristen Rudd, PhD; Email: krudd@uccs.edu
      • Principal Investigator: Marissa Baranauskas, PhD
      • Principal Investigator: Kristen Rudd, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• participates in structured running or cycling exercise for at least 30 minutes on 4 days per week or more
• have regular periods every 21 to 35 days
• have not used hormonal contraceptives for at least the past 6 months
• are not currently or trying to become pregnant or are breastfeeding, and have not been pregnant or breastfeeding for the past 12 months
• have never been diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome [PCOS], endometriosis, premenstrual dysphoric disorder [PMDD], menstrual migraines, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
• have never been diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)

Exclusion Criteria:

• missing > 4 consecutive days of aerobic exercise (i.e., running, cycling, cross training) if assigned to the exercise intervention groups
• they indicate they "Could not participate at all due to a health problem" or have had to modify their exercise training, felt their injury, illness, or other health problem has affected their exercise performance, or experienced symptoms/ health complaints greater than "To a minor extent" on the Oslo Sports Trauma Research Center Questionnaire (exercise training intervention group)
• demonstrate clinical low energy availability as defined as energy availability <30 Kcal/kg fat free mass in the first two months of at-home monitoring
• report menstrual cycle lengths <21 days or >35 days in the first two months of at-home monitoring
• do not demonstrate an anticipated rise in progesterone levels during the latter half of their cycle and luteinizing hormone levels at mid-cycle compared to tests taken during the first few days after menses in the first two months of at-home monitoring
• begin taking a hormonal contraceptive
• become pregnant
• are diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome [PCOS], endometriosis, premenstrual dysphoric disorder [PMDD], menstrual migraines, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
• are diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes), 10) are diagnosed with a major cardiovascular disease, respiratory disease, or musculoskeletal injury
• are unable to follow instructions for any of the procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will be asked to maintain their usual physical activity and lifestyle habits.
Experimental: Psychosocial Stress; Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits.	Behavioral: Psychosocial Stress; cognitive tasks
Experimental: Exercise Stress; The duration of participant's weekly running or cycling mileage will be increased by 30% while intensity is maintained.	Behavioral: Exercise Stress; Increased exercise volume
Experimental: Exercise + Psychosocial Stress; 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.	Behavioral: Exercise Stress; Increased exercise volume; Behavioral: Psychosocial Stress; cognitive tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary estrone-3-glucuronide (E3G)	ng/mL	3 months
Urinary pregnanediol glucuronide (PdG)	ug/mL	3 months
Urinary luteinizing hormone (LH)	MIU/mL	3 months
Menstrual cycle length	days	3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Colorado Springs

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: menstrual cycle; functional hypothalamic amenorrhea; female athlete
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Amenorrhea; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Respiratory Function Tests; Ergometry; Exercise Test
• Other Study ID Numbers: CRCW FHA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No