Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

Study Overview
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Brief Summary
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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
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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).

Official Title
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Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

Conditions
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Premenstrual Dysphoric Disorder

Intervention / Treatment
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* Procedure: Individualized laboratory test


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Procedure (all participants)<br>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) | Procedure: Individualized laboratory test<br>* Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone Analysis | Allopregnanolone, cortisol, progesterone | 2 hours | 
| Cardiovascular function | Heart Rate, Heart Rate Variability | 2 hours | 
| Affect | Subjective Mood States | 2 hours | 
| Estradiol concentrations at 6 menstrual cycle sub-phases | Mean levels of estradiol | One menstrual cycle |