Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premenstrual Dysphoric Disorder
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 129
- Locations
- 1
- Primary Endpoint
- Hormone Analysis
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Ajna Hamidovic, PharmD, MS
Assistant Professor
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- •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)
Outcomes
Primary Outcomes
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