Stress and Menstrual Health

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07566260
Status
Recruiting

Conditions

  • Menstrual Dysfunction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Heat stress — OTHER
    Stress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna
  • Sleep stress — OTHER
    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 — OTHER
    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 Details

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.

Key Dates

Start date
May 28, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Total daily energy expenditure (TDEE) [ Time Frame: Baseline (Month 2), Intervention (Month 4) ]

Locations (1)

FacilityCityStateZIP
Duke UniversityDurhamNorth Carolina27708

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