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Completed

NCT Number: NCT03862469

Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

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).

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Key information

Conditions

Premenstrual Dysphoric Disorder Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Department of Pharmacy Practice

Chicago, Illinois, 60612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Individualized laboratory test

Procedure

Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.

Primary outcomes

  1. Hormone Analysis

    Time frame: -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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Acronym: PHASE Project

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2019
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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