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NCT03862469: PHASE Project

Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

Completed NA Results posted Last updated 24 April 2025
What this trial tests

NA trial testing Individualized laboratory test in Premenstrual Dysphoric Disorder in 129 participants. Completed in 1 September 2023.

Timeline
26 September 2019
Primary endpoint
1 September 2023
1 September 2023

Quick facts

Lead sponsorUniversity of Illinois at Chicago
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment129
Start date26 September 2019
Primary completion1 September 2023
Estimated completion1 September 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Illinois at Chicago

Who can join

Adults 18 to 35, female only, with Premenstrual Dysphoric Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hormone Analysis Primary · -20, +20, +30, +40, +50, +65, +90 minutes in the late luteal phase of the menstrual cycle (one day between -1 to -6 days of the subsequent menstrual cycle)

Cortisol

-20 minute timepoint
GroupValue95% CI
PMDD Patients70.7± 26.4
Healthy Controls57.8± 21.9
+20 minute timepoint
GroupValue95% CI
PMDD Patients114± 53.4
Healthy Controls97.3± 39.9
+30 minute timepoint
GroupValue95% CI
PMDD Patients111± 43.6
Healthy Controls109± 43.6
+40 minute timepoint
GroupValue95% CI
PMDD Patients97± 48.9
Healthy Controls100± 32.4
+50 minute timepoint
GroupValue95% CI
PMDD Patients86.9± 39.4
Healthy Controls93.3± 29.2
+65 minute timepoint
GroupValue95% CI
PMDD Patients73.5± 31.6
Healthy Controls78.4± 24
+90 minute timepoint
GroupValue95% CI
PMDD Patients70.6± 36.6
Healthy Controls69± 18.5

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Reduced Dehydroepiandrosterone-Sulfate Levels in the Mid-Luteal Subphase of the Menstrual Cycle: Implications to Women's Health Research.
    Hamidovic A, Soumare F, Naveed A, Davis J, et al · · 2022 · cited 14× · PMID 36295844 · DOI 10.3390/metabo12100941
  2. Allopregnanolone Is Associated with a Stress-Induced Reduction of Heart Rate Variability in Premenstrual Dysphoric Disorder.
    Hamidovic A, Davis J, Soumare F, Naveed A, et al · · 2023 · cited 10× · PMID 36836088 · DOI 10.3390/jcm12041553
  3. Blunted Cortisol Response to Acute Psychosocial Stress in Women With Premenstrual Dysphoric Disorder.
    Hamidovic A, Davis J, Soumare F. · · 2024 · cited 6× · PMID 38451747 · DOI 10.1093/ijnp/pyae015
  4. Association between Neuroticism and Premenstrual Affective/Psychological Symptomatology.
    Hamidovic A, Dang N, Khalil D, Sun J. · · 2022 · cited 6× · PMID 36381676 · DOI 10.3390/psychiatryint3010005
  5. Trajectories of Allopregnanolone and Allopregnanolone to Progesterone Ratio across the Six Subphases of Menstrual Cycle.
    Hamidovic A, Davis J, Soumare F, Datta A, et al · · 2023 · cited 4× · PMID 37189398 · DOI 10.3390/biom13040652
  6. Mid-Luteal Progesterone Is Inversely Associated with Premenstrual Food Cravings.
    Hamidovic A, Soumare F, Naveed A, Davis J. · · 2023 · cited 3× · PMID 36904096 · DOI 10.3390/nu15051097
  7. Waist Circumference and Its Association With Premenstrual Food Craving: The PHASE Longitudinal Study.
    Dang N, Khalil D, Sun J, Naveed A, et al · · 2022 · cited 3× · PMID 35573360 · DOI 10.3389/fpsyt.2022.784316
  8. Behavioral Symptomatology in the Premenstruum.
    Dang N, Khalil D, Sun J, Naveed A, et al · · 2022 · cited 1× · PMID 35884622 · DOI 10.3390/brainsci12070814

Verify or expand the search:

Other recruiting trials for Premenstrual Dysphoric Disorder

Currently open trials in the same condition.

Other University of Illinois at Chicago trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing