600 Participants NeededMy employer runs this trial

Stress for Menstrual Dysfunction

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

HP

Herman Pontzer, PhD

Principal Investigator

Duke University Evolutionary Anthropology Department

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women aged 18-45. For the exercise group, participants must be mostly inactive (less than 60 minutes of moderate or vigorous activity per week).

Inclusion Criteria

Habitually sedentary (less than 60 minutes MVPA/week) for Exercise cohort
I am a pre-menopausal woman between 18 and 45 years old.

Exclusion Criteria

Individuals with incidence in the last 6 months of childbirth, lactation, pregnancy, or functional hypothalamic amenorrhea (FHA)
Individuals who have undergone or are undergoing menopause
MVPA >60 min/week (for Exercise cohort)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo baseline measurements for stress and sex hormone concentrations and energy expenditure

1 month
Multiple visits for sample collection and measurements

Control

Participants continue with normal activities while undergoing measurements for stress and sex hormone concentrations

1 month
Multiple visits for sample collection and measurements

Intervention

Participants undergo stress interventions including heat, sleep, and exercise stressors, with measurements for hormone concentrations and energy expenditure

2 months
Frequent visits for intervention and sample collection

Follow-up

Participants are monitored for changes in stress and sex hormone concentrations and energy expenditure after interventions

1 month
Multiple visits for follow-up measurements

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests how different types of stress—heat, sleep loss, and exercise—affect menstrual health and hormone levels in women. Participants will experience these stressors over two months during a six-month study period.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Sleep StressExperimental Treatment1 Intervention
Group II: Heat StressExperimental Treatment1 Intervention
Group III: Exercise StressExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+