Clinical trial NCT03862469: Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Official title: Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Dysphoric Disorder
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

Eligibility criteria: 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)

Primary outcomes:
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Department of Pharmacy Practice
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Ajna Hamidovic, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
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