Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

University of Illinois at Chicago129 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

129

Conditions

Premenstrual Dysphoric Disorder

Interventions

Individualized laboratory testPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Illinois Department of Pharmacy Practice

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Hormone Analysis

Cortisol

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)

Data from ClinicalTrials.gov

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