An interventional study of Individualized laboratory test in Premenstrual Dysphoric Disorder, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Prevention
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).
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).
42 studies on the registry are indexed under Premenstrual Dysphoric Disorder; 10 are open to participants now.
This study's enrollment of 129 is above the median of 58 across 32 interventional studies indexed under Premenstrual Dysphoric Disorder.
Browse Premenstrual Dysphoric Disorder studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Individualized laboratory test
Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.
Hormone Analysis
Cortisol
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)
| Milestone | All Participants |
|---|---|
| Started | 129 |
| Pmdd | 17 |
| Healthy control | 17 |
| Completed | 34 |
| Not completed | 95 |
Cortisol
| ng/mL | PMDD Patients | Healthy Controls |
|---|---|---|
| -20 minute timepoint | 70.7 ± 26.4 | 57.8 ± 21.9 |
| +20 minute timepoint | 114 ± 53.4 | 97.3 ± 39.9 |
| +30 minute timepoint | 111 ± 43.6 | 109 ± 43.6 |
| +40 minute timepoint | 97 ± 48.9 | 100 ± 32.4 |
| +50 minute timepoint | 86.9 ± 39.4 | 93.3 ± 29.2 |
| +65 minute timepoint | 73.5 ± 31.6 | 78.4 ± 24 |
| +90 minute timepoint | 70.6 ± 36.6 | 69 ± 18.5 |
Collected over 12:00 to 15:30 on the day of the session in the late luteal phase of the 2nd menstrual cycle of the study (one day between -1 to -6 days of the subsequent menstrual cycle). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | PMDD | Controls | Total |
|---|---|---|---|
| Mean | 26.0 ± 4.8 | 26.36 ± 5.1 | 26.2 ± 5.0 |
| Sex: Female, Male(Participants) | PMDD | Controls | Total |
|---|---|---|---|
| Female | 15 | 14 | 29 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | PMDD | Controls | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 4 | 8 |
| Not Hispanic or Latino | 11 | 9 | 20 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | PMDD | Controls | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 5 | 4 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 5 | 7 | 12 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Age of Menarche(years) | PMDD | Controls | Total |
|---|---|---|---|
| Mean | 11.4 ± 1.71 | 12.0 ± 1.54 | 11.8 ± 1.60 |
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Premenstrual Dysphoric Disorder→
University of Illinois at Chicago