N/A N=129 Prevention

Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

Premenstrual Dysphoric Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03862469 ↗

Enrolled (actual)

129

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Hormone Analysis — 70.7; 57.8; 114; 97.3 ng/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Individualized laboratory test (Procedure)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Illinois at Chicago
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Hormone Analysis	70.7; 57.8; 114; 97.3; 111; 109	—

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 (i.e., premenstrual dysphoric disorder).

Eligibility Criteria

Inclusion Criteria

Female
Aged 18-35 years, established by visual inspection of a government-issued ID
Average menstrual cycle 21-35 days

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03862469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.