Status:
COMPLETED
Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Premenstrual Dysphoric Disorder
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
PHASE is designed to evaluate neuroactive hormone trajectories across the menstrual cycle and endocrine, autonomic, and subjective responses to psychosocial stress in women suffering from severe PMS (...
Detailed Description
Female volunteers will be recruited from the community for participation in this 3-menstrual cycle study. In the first two menstrual cycles, study participants will chart their symptoms and and ovulat...
Eligibility Criteria
Inclusion
- Female
- Aged 18-35 years, established by visual inspection of a government-issued ID
- Average menstrual cycle 21-35 days
Exclusion
- Lifetime DSM-5 Axis 1 disorder (except anxiety and depression), as documented in the Mental Health Interview
- Current DSM-5 Axis depressive or anxiety disorder, as documented in the Mental Health Interview
- Positive urine drug screen test
- Breath alcohol concentration \>0.00%
- Self-reported smoker or carbon monoxide concentration ≥ 6 ppm
- Irregular menstrual cycle
- Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant
- Moderate or high suicide risk
- Shipley IQ (vocabulary standard score) \> 80
- Any prescription medications (including hormonal forms of birth control)
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03862469
Start Date
September 26 2019
End Date
September 1 2023
Last Update
April 24 2025
Active Locations (1)
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1
University of Illinois Department of Pharmacy Practice
Chicago, Illinois, United States, 60612