search
Back to results

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

Primary Purpose

Amenorrhea Secondary

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Stress
Psychosocial Stress
Sponsored by
University of Colorado, Colorado Springs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Amenorrhea Secondary focused on measuring functional hypothalamic amenorrhea, menstrual cycle, female athlete

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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 structured running or cycling exercise 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 or 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

Sites / Locations

  • University of Colorado Colorado SpringsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Exercise Stress

Psychosocial Stress

Exercise + Psychosocial Stress

Arm Description

Participants will be asked to maintain their usual physical activity and lifestyle habits.

The duration of participant's weekly running or cycling mileage will be increased by 30% while intensity is maintained.

Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits.

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.

Outcomes

Primary Outcome Measures

Urinary estrone-3-glucuronide (E3G)
ng/mL
Urinary pregnanediol glucuronide (PdG)
ug/mL
Urinary luteinizing hormone (LH)
MIU/mL
Menstrual cycle length
days

Secondary Outcome Measures

Full Information

First Posted
July 21, 2023
Last Updated
September 29, 2023
Sponsor
University of Colorado, Colorado Springs
search

1. Study Identification

Unique Protocol Identification Number
NCT05967819
Brief Title
Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
Acronym
FHA
Official Title
Independent and Synergistic Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Colorado Springs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amenorrhea Secondary
Keywords
functional hypothalamic amenorrhea, menstrual cycle, female athlete

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be asked to maintain their usual physical activity and lifestyle habits.
Arm Title
Exercise Stress
Arm Type
Experimental
Arm Description
The duration of participant's weekly running or cycling mileage will be increased by 30% while intensity is maintained.
Arm Title
Psychosocial Stress
Arm Type
Experimental
Arm Description
Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits.
Arm Title
Exercise + Psychosocial Stress
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Stress
Intervention Description
Increased exercise volume
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Stress
Intervention Description
cognitive tasks
Primary Outcome Measure Information:
Title
Urinary estrone-3-glucuronide (E3G)
Description
ng/mL
Time Frame
3 months
Title
Urinary pregnanediol glucuronide (PdG)
Description
ug/mL
Time Frame
3 months
Title
Urinary luteinizing hormone (LH)
Description
MIU/mL
Time Frame
3 months
Title
Menstrual cycle length
Description
days
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 structured running or cycling exercise 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 or 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa Baranauskas, PhD
Phone
719-255-4475
Email
mbaranau@uccs.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Rudd, PhD
Email
krudd@uccs.edu
Facility Information:
Facility Name
University of Colorado Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marissa Baranauskas, PhD
Phone
719-255-4475
Email
mbaranau@uccs.edu
First Name & Middle Initial & Last Name & Degree
Kristen Rudd, PhD
Email
krudd@uccs.edu
First Name & Middle Initial & Last Name & Degree
Marissa Baranauskas, PhD
First Name & Middle Initial & Last Name & Degree
Kristen Rudd, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs