| NCT ID | NCT07566260 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Menstrual Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-05-28 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2026-05-28 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Adult pre-menopausal females, 18-45 years old * 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 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)
Contact & Investigator
Herman Pontzer, PhD
PRINCIPAL INVESTIGATOR
Duke University Evolutionary Anthropology Department
Frequently Asked Questions
Who can join the NCT07566260 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Menstrual Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07566260 currently recruiting?
Yes, NCT07566260 is actively recruiting participants. Visit ClinicalTrials.gov or contact Duke University to inquire about joining.
Where is the NCT07566260 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07566260 clinical trial?
NCT07566260 is sponsored by Duke University. The principal investigator is Herman Pontzer, PhD at Duke University Evolutionary Anthropology Department. The trial plans to enroll 600 participants.