Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

Not Applicable

Completed

• Conditions: Premenstrual Dysphoric Disorder
• Interventions: Procedure: Individualized laboratory test

• Registration Number: NCT03862469
• Lead Sponsor: University of Illinois at Chicago

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 (i.e., premenstrual dysphoric disorder).

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 ovulation. Study participants will continue to perform ovulation testing during their third menstrual cycle in which they will attend one individualized task session and provide 8 serum samples at different timepoints across the menstrual cycle. Primary analyses will contrast neuroactive hormone trajectories across the menstrual cycle and stress reactivity according to study groups (PMDD vs healthy).

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Study Start: 2019-09-26
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Results First Submitted: 2025-02-06
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Results First Posted: 2025-04-24
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Procedure (all participants)	Individualized laboratory test	Diagnostic Phase (2 months): at-home urine hormone testing and completion of daily online surveys. Individualized Task (-6 to -2 days from the subsequent menstrual cycle)

Primary Outcome Measures

Name	Time	Method
Hormone Analysis	-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

Trial Locations

Locations (1)

University of Illinois Department of Pharmacy Practice; 🇺🇸 Chicago, Illinois, United States