Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT07566260

Conditions

Menstrual Dysfunction

Eligibility Criteria

Sex: Female

Age: 22 - 38

Healthy Volunteers: Accepted

Interventions

Heat stress

Sleep stress

Exercise stress

Study Details

Brief 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. 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.

Conditions

Menstrual Dysfunction

Study ID

NCT07566260

Start date

May 28, 2026

Status verified date

Apr, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 38

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Heat Stress

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).

experimental: Sleep Stress

Sleep restriction to 4-6 hours/night for 5 consecutive nights (on days 3-8 or 4-9 of follicular phase).

experimental: Exercise Stress

One-hour cycling at 60-75% predicted max HR for 5 consecutive days (days 4-8 or 5-9 of follicular phase).

Interventions

Heat stress

Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna

Sleep stress

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 stress

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.

Primary outcome measure

  • Total daily energy expenditure (TDEE) [ Time Frame: Control (Month 3), Intervention (Month 4) ]
  • Basal metabolic rate (BMR) [ Time Frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6) ]
  • Sex hormone concentration (estradiol) [ Time Frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6) ]
  • Sex hormone concentration (progesterone) [ Time Frame: Baseline (Month 2), Control (Month 3), Intervention (Months 4-5), and Follow-up (Month 6) ]

Central Contacts and Locations

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Mary Joy

7249317802mary.joy@duke.edu

More Information

Sponsor

Duke University

Last update posted

Sep 9, 2026

Last verified

Apr, 2026

Keywords

  • Stress
  • Menstruation
  • Energy Expenditure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.