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 — OTHERStress-Heat participants will undergo supervised 40-min sessions in a 70-80˚C sauna
- Sleep stress — OTHERStress-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 — OTHERStress-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 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).
- Experimental: Sleep StressSleep restriction to 4-6 hours/night for 5 consecutive nights (on days 3-8 or 4-9 of follicular phase).
- Experimental: Exercise StressOne-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)
| Facility | City | State | ZIP |
|---|---|---|---|
| Duke University | Durham | North Carolina | 27708 |