CompletedNot Applicable

Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

United States129 participantsStarted 2019-09-26

Plain-language 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).

Who can participate

Age range18 Years – 35 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Hormone Analysis

Timeframe: -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)

Trial details

NCT IDNCT03862469

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

Results submitted2025-02-06

View on ClinicalTrials.gov More Premenstrual Dysphoric Disorder trials