N/A
Completed N=129
Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Source: ClinicalTrials.gov NCT03862469 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Hormone Analysis — 70.7; 57.8; 114; 97.3 ng/mL
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hormone Analysis |
70.7; 57.8; 114; 97.3; 111; 109 | — |
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)
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. Informational only — not medical advice.