Amenorrhea SecondaryFHANCT05967819
Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
A study testing Exercise Stress and Psychosocial Stress in people with Amenorrhea Secondary, run by University of Colorado, Colorado Springs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amenorrhea Secondary
- What is being tested?
- Exercise Stress and Psychosocial Stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristen Rudd, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Colorado Colorado Springs
Colorado Springs, Colorado, 80918
Marissa Baranauskas, PhD, 719-255-4475, mbaranau@uccs.edu
Kristen Rudd, PhD, krudd@uccs.edu
About this study
Official title: 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?
Read more
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.
- Conditions
- Amenorrhea Secondary
- Being tested
- Exercise Stress, Psychosocial Stress
- Keywords
- functional hypothalamic amenorrhea, menstrual cycle, female athlete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise StressBehavioural
Increased exercise volume
Psychosocial StressBehavioural
cognitive tasks
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will be asked to maintain their usual physical activity and lifestyle habits. |
| Exercise Stress | Experimental | The duration of participant's weekly running or cycling mileage will be increased by 30% while intensity is maintained. Receives: Behavioral: Exercise Stress |
| Psychosocial Stress | Experimental | Participants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits. Receives: Behavioral: Psychosocial Stress |
| Exercise + Psychosocial Stress | Experimental | 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. Receives: Behavioral: Exercise Stress; Behavioral: Psychosocial Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary estrone-3-glucuronide (E3G)
ng/mL
Measured: 3 months
Urinary pregnanediol glucuronide (PdG)
ug/mL
Measured: 3 months
Urinary luteinizing hormone (LH)
MIU/mL
Measured: 3 months
Menstrual cycle length
days
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start9 Aug 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amenorrhea SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marissa Baranauskas, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967819
- Sponsor's protocol ID
- CRCW FHA
- Acronym
- FHA
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent and Synergistic Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
- ClinicalTrials.gov ID
- NCT05967819
- Acronym / sponsor ID
- FHA / CRCW FHA
- Conditions
- Amenorrhea Secondary
- Keywords
- functional hypothalamic amenorrhea, menstrual cycle, female athlete
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will be asked to maintain their usual physical activity and lifestyle habits. |
| Exercise Stress | Experimental | Behavioral: Exercise StressThe duration of participant's weekly running or cycling mileage will be increased by 30% while intensity is maintained. |
| Psychosocial Stress | Experimental | Behavioral: Psychosocial StressParticipants will be asked to complete cognitive function tasks designed to be stressful while maintaining their usual physical activity habits. |
| Exercise + Psychosocial Stress | Experimental | Behavioral: Exercise Stress, Behavioral: Psychosocial StressParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise StressIncreased exercise volume | Behavioural | Exercise + Psychosocial Stress, Exercise Stress |
| Psychosocial Stresscognitive tasks | Behavioural | Exercise + Psychosocial Stress, Psychosocial Stress |
Primary outcome
Urinary estrone-3-glucuronide (E3G)
Time frame: 3 months
ng/mL
Urinary pregnanediol glucuronide (PdG)
Time frame: 3 months
ug/mL
Urinary luteinizing hormone (LH)
Time frame: 3 months
MIU/mL
Menstrual cycle length
Time frame: 3 months
days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen Rudd, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Stress and Psychosocial Stress in people with Amenorrhea Secondary, run by University of Colorado, Colorado Springs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marissa Baranauskas, PhD (719-255-4475, mbaranau@uccs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary estrone-3-glucuronide (E3G) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.