Menstrual DysfunctionNCT07566260
Stress and Menstrual Health
A study testing Heat stress, Sleep stress and Exercise stress in people with Menstrual Dysfunction, run by Duke University at 1 site in United States.
Trial summary
The goal of this experimental study is to determine how stressors that do not directly impact energy state or energy demands (hereafter called "non-energetic stressors") affect reproductive health in pre-menopausal women. Read more about this study
- Who is it for?
- Ages 22 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Dysfunction
- What is being tested?
- Heat stress, Sleep stress and Exercise stress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to Aug 2029
- 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 22 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult pre-menopausal females, 22-38 years old with a BMI of 18.5-30.0
- Habitually sedentary (less than 60 minutes MVPA/week) for Exercise cohort
Who cannot join
- Individuals on hormonal birth control (oral contraception, injection, implant, or intrauterine device)
- Individuals with incidence in the last 6 months of childbirth, lactation, pregnancy, or functional hypothalamic amenorrhea (FHA)
- Individuals with a BMI <18.5 or >30.0
- Individuals with reproductive disorders (e.g. endometriosis, polycystic ovarian syndrome (PCOS))
- Individuals taking thyroid medications
- Individuals who have undergone or are undergoing menopause
- MVPA >60 min/week (for Exercise cohort)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27708
Mary Joy, 7249317802, mary.joy@duke.edu
About this study
Official title: The Influence of Non-energetic Stressors on Human Menstrual Function
The goal of this experimental study is to determine how stressors that do not directly impact energy state or energy demands (hereafter called "non-energetic stressors") affect reproductive health in pre-menopausal women. It aims to do this by answering the following main questions: Do non-energetic stressors create a stress response? How does the stress response impact sex hormone concentration and thus menstrual dysfunction? If stress caused by non-energetic stressors does impact sex hormone concentration, does it do so primarily at the level of the brain or the level of the ovary? Participants will be enrolled in this study for 6 months. For two of these months, they will undergo a short stress intervention and provide samples to measure hormone concentration and total energy expenditure.
Read the detailed description
The Reproductive Suppression Model posits that due to the high cost and failure rate of human reproduction, the female body maximizes lifetime reproductive fitness by suppressing reproduction during poor conditions (where likelihood of offspring survival is low) until conditions are more favorable. The hormonal mechanism for this suppression when calories are scarce and the female body is in low energy availability (LEA) has been studied. However, the mechanism for this suppression in the presence of stressors unrelated to low energy availability, but which could still negatively impact offspring survival, is much less clear. The investigators define such stressors, which do not impact energy state or energetic demands, as "non-energetic stressors." Thus, the aim of this study is to determine if non-energetic stressors drive reproductive suppression in humans. The investigators will assess this by testing the impact of a stress intervention on the stress hormones cortisol and norepinephrine, and in turn if the levels of these stress hormones predict the levels of sex hormones associated with the menstrual cycle. Finally, the investigators will assess if changes in stress hormones change total and basal energy expenditure.
- Conditions
- Menstrual Dysfunction
- Being tested
- Heat stress, Sleep stress, Exercise stress
- Keywords
- Stress, Menstruation, Energy Expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat stressOther
Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna
Sleep stressOther
Stress-Sleep participants will be asked to sleep for between 4 and 6 hours per night, with compliance monitored via their activity monitors and self-reported sleep diaries. Participants will be requested to maintain normal wake cycles without midday sleep.
Exercise stressOther
Stress-Exercise participants will come to the Pontzer Lab to complete a one-hour cycling workout on a Lode Corival CPET ergometer/exercise bike at 60-75% predicted maximum heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Heat Stress | Experimental | Heat stress via 70-80°C sauna exposure for 45-min sessions on 5 consecutive days (days 4-8 or 5-9 of follicular phase). Receives: Other: Heat stress |
| Sleep Stress | Experimental | Sleep restriction to 4-6 hours/night for 5 consecutive nights (on days 3-8 or 4-9 of follicular phase). Receives: Other: Sleep stress |
| Exercise Stress | Experimental | One-hour cycling at 60-75% predicted max HR for 5 consecutive days (days 4-8 or 5-9 of follicular phase). Receives: Other: Exercise stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily energy expenditure (TDEE)
TDEE (kcal) will be measured over a 7-day period during the Baseline and first Intervention month using the doubly-labeled water (DLW) method. DLW is a safe and reliable method for capturing free-living TDEE and has been validated for human studies. The DLW method adds a known amount of stable isotopes, oxygen-18 (18O) and deuterium (2H), to a participant's total body water (TBW) via ingestion and then measures the depletion rate of these isotopes as they are removed from the body via urine and exhalation.
Measured: Control (Month 3), Intervention (Month 4)
Basal metabolic rate (BMR)
BMR (kcal/d) will be estimated via indirect calorimetry. Participants will be asked to come in for a lab visit on a day of their choice within 2-7 days post-ovulation prior to consuming breakfast or any non-water beverage and after having refrained from exercise for 24 hours pre-measurement. Participants will lie on an exam bed in the Pontzer Lab and have a clear plastic hood connected to a COSMED Quark RMR machine placed over their head for approximately 25-30 minutes. This hood will collect exhaled air, which will be measured for CO2 production to estimate BMR.
Measured: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Sex hormone concentration (estradiol)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
Measured: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Sex hormone concentration (progesterone)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
Measured: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Secondary outcomes (5)
Stress hormone concentration (norepinephrine)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
Measured: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Stress hormone concentration (cortisol)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
Measured: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Stress hormone concentration (salivary alpha-amylase)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
Measured: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Sex hormone concentration (luteinizing hormone (LH))
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
Measured: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Sex hormone concentration (follicle-stimulating hormone (FSH))
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
Measured: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start28 May 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual DysfunctionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herman Pontzer, PhD, Principal investigator, Duke University Evolutionary Anthropology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566260
- Sponsor's protocol ID
- Pro00119656
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Non-energetic Stressors on Human Menstrual Function
- ClinicalTrials.gov ID
- NCT07566260
- Acronym / sponsor ID
- Pro00119656
- Conditions
- Menstrual Dysfunction
- Keywords
- Stress, Menstruation, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 5 May 2026 (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 experimental study is to determine how stressors that do not directly impact energy state or energy demands (hereafter called "non-energetic stressors") affect reproductive health in pre-menopausal women. It aims to do this by answering the following main questions: Do non-energetic stressors create a stress response? How does the stress response impact sex hormone concentration and thus menstrual dysfunction? If stress caused by non-energetic stressors does impact sex hormone concentration, does it do so primarily at the level of the brain or the level of the ovary? Participants will be enrolled in this study for 6 months. For two of these months, they will undergo a short stress intervention and provide samples to measure hormone concentration and total energy expenditure.
Detailed description
The Reproductive Suppression Model posits that due to the high cost and failure rate of human reproduction, the female body maximizes lifetime reproductive fitness by suppressing reproduction during poor conditions (where likelihood of offspring survival is low) until conditions are more favorable. The hormonal mechanism for this suppression when calories are scarce and the female body is in low energy availability (LEA) has been studied. However, the mechanism for this suppression in the presence of stressors unrelated to low energy availability, but which could still negatively impact offspring survival, is much less clear. The investigators define such stressors, which do not impact energy state or energetic demands, as "non-energetic stressors." Thus, the aim of this study is to determine if non-energetic stressors drive reproductive suppression in humans. The investigators will assess this by testing the impact of a stress intervention on the stress hormones cortisol and norepinephrine, and in turn if the levels of these stress hormones predict the levels of sex hormones associated with the menstrual cycle. Finally, the investigators will assess if changes in stress hormones change total and basal energy expenditure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heat Stress | Experimental | Other: Heat stressHeat stress via 70-80°C sauna exposure for 45-min sessions on 5 consecutive days (days 4-8 or 5-9 of follicular phase). |
| Sleep Stress | Experimental | Other: Sleep stressSleep restriction to 4-6 hours/night for 5 consecutive nights (on days 3-8 or 4-9 of follicular phase). |
| Exercise Stress | Experimental | Other: Exercise stressOne-hour cycling at 60-75% predicted max HR for 5 consecutive days (days 4-8 or 5-9 of follicular phase). |
Who may qualify
- Ages
- 22 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult pre-menopausal females, 22-38 years old with a BMI of 18.5-30.0
- Habitually sedentary (less than 60 minutes MVPA/week) for Exercise cohort
Key exclusion criteria (7 listed)
- Individuals on hormonal birth control (oral contraception, injection, implant, or intrauterine device)
- Individuals with incidence in the last 6 months of childbirth, lactation, pregnancy, or functional hypothalamic amenorrhea (FHA)
- Individuals with a BMI <18.5 or >30.0
- Individuals with reproductive disorders (e.g. endometriosis, polycystic ovarian syndrome (PCOS))
- Individuals taking thyroid medications
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 |
|---|---|---|
| Heat stressStress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna | Other | Heat Stress |
| Sleep stressStress-Sleep participants will be asked to sleep for between 4 and 6 hours per night, with compliance monitored via their activity monitors and self-reported sleep diaries. Participants will be requested to maintain normal wake cycles without midday sleep. | Other | Sleep Stress |
| Exercise stressStress-Exercise participants will come to the Pontzer Lab to complete a one-hour cycling workout on a Lode Corival CPET ergometer/exercise bike at 60-75% predicted maximum heart rate. | Other | Exercise Stress |
Primary outcome
Total daily energy expenditure (TDEE)
Time frame: Control (Month 3), Intervention (Month 4)
TDEE (kcal) will be measured over a 7-day period during the Baseline and first Intervention month using the doubly-labeled water (DLW) method. DLW is a safe and reliable method for capturing free-living TDEE and has been validated for human studies. The DLW method adds a known amount of stable isotopes, oxygen-18 (18O) and deuterium (2H), to a participant's total body water (TBW) via ingestion and then measures the depletion rate of these isotopes as they are removed from the body via urine and exhalation.
Basal metabolic rate (BMR)
Time frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
BMR (kcal/d) will be estimated via indirect calorimetry. Participants will be asked to come in for a lab visit on a day of their choice within 2-7 days post-ovulation prior to consuming breakfast or any non-water beverage and after having refrained from exercise for 24 hours pre-measurement. Participants will lie on an exam bed in the Pontzer Lab and have a clear plastic hood connected to a COSMED Quark RMR machine placed over their head for approximately 25-30 minutes. This hood will collect exhaled air, which will be measured for CO2 production to estimate BMR.
Sex hormone concentration (estradiol)
Time frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
Sex hormone concentration (progesterone)
Time frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Samples will be assayed via enzyme-linked immunosorbent assay (ELISA) in the Pontzer Lab.
5 secondary outcomes
Stress hormone concentration (norepinephrine)
Time frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Stress hormone concentration (cortisol)
Time frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Stress hormone concentration (salivary alpha-amylase)
Time frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Sex hormone concentration (luteinizing hormone (LH))
Time frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
Sex hormone concentration (follicle-stimulating hormone (FSH))
Time frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6)
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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.
Herman Pontzer, PhD principal investigator
Duke University Evolutionary Anthropology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat stress, Sleep stress and Exercise stress in people with Menstrual Dysfunction, run by Duke University 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 2 inclusion and 7 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 9 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total daily energy expenditure (TDEE) (time frame: Control (Month 3), Intervention (Month 4)). 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 9 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.