Premenstrual Hormonal and Affective State Evaluation (PHASE) Project (NCT03862469) | Clinical Trial Compass
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 range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)