Trial Outcomes & Findings for Premenstrual Hormonal and Affective State Evaluation (PHASE) Project (NCT NCT03862469)
NCT ID: NCT03862469
Last Updated: 2025-04-24
Results Overview
Cortisol
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome 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)
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
All Participants
Participants were retroactively assigned to PMDD versus healthy control cohort after they were diagnosed during their 2nd or 3rd menstrual cycle
|
|---|---|
|
Overall Study
STARTED
|
129
|
|
Overall Study
PMDD
|
17
|
|
Overall Study
Healthy Control
|
17
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
95
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age, Continuous
Baseline characteristics by cohort
| Measure |
PMDD
n=15 Participants
PMDD patients
|
Controls
n=14 Participants
Healthy Controls
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.0 years
STANDARD_DEVIATION 4.8 • n=5 Participants • Age, Continuous
|
26.36 years
STANDARD_DEVIATION 5.1 • n=7 Participants • Age, Continuous
|
26.2 years
STANDARD_DEVIATION 5.0 • n=5 Participants • Age, Continuous
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants • Sex: Female, Male
|
14 Participants
n=7 Participants • Sex: Female, Male
|
29 Participants
n=5 Participants • Sex: Female, Male
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • Sex: Female, Male
|
0 Participants
n=7 Participants • Sex: Female, Male
|
0 Participants
n=5 Participants • Sex: Female, Male
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants • Ethnicity (NIH/OMB)
|
4 Participants
n=7 Participants • Ethnicity (NIH/OMB)
|
8 Participants
n=5 Participants • Ethnicity (NIH/OMB)
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants • Ethnicity (NIH/OMB)
|
9 Participants
n=7 Participants • Ethnicity (NIH/OMB)
|
20 Participants
n=5 Participants • Ethnicity (NIH/OMB)
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Ethnicity (NIH/OMB)
|
1 Participants
n=7 Participants • Ethnicity (NIH/OMB)
|
1 Participants
n=5 Participants • Ethnicity (NIH/OMB)
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants • Race (NIH/OMB)
|
0 Participants
n=7 Participants • Race (NIH/OMB)
|
1 Participants
n=5 Participants • Race (NIH/OMB)
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants • Race (NIH/OMB)
|
4 Participants
n=7 Participants • Race (NIH/OMB)
|
9 Participants
n=5 Participants • Race (NIH/OMB)
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Race (NIH/OMB)
|
0 Participants
n=7 Participants • Race (NIH/OMB)
|
0 Participants
n=5 Participants • Race (NIH/OMB)
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • Race (NIH/OMB)
|
2 Participants
n=7 Participants • Race (NIH/OMB)
|
4 Participants
n=5 Participants • Race (NIH/OMB)
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants • Race (NIH/OMB)
|
7 Participants
n=7 Participants • Race (NIH/OMB)
|
12 Participants
n=5 Participants • Race (NIH/OMB)
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants • Race (NIH/OMB)
|
1 Participants
n=7 Participants • Race (NIH/OMB)
|
2 Participants
n=5 Participants • Race (NIH/OMB)
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • Race (NIH/OMB)
|
0 Participants
n=7 Participants • Race (NIH/OMB)
|
1 Participants
n=5 Participants • Race (NIH/OMB)
|
|
Age of Menarche
|
11.4 years
STANDARD_DEVIATION 1.71 • n=5 Participants • Age of Menarche
|
12.0 years
STANDARD_DEVIATION 1.54 • n=7 Participants • Age of Menarche
|
11.8 years
STANDARD_DEVIATION 1.60 • n=5 Participants • Age of Menarche
|
PRIMARY outcome
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)Cortisol
Outcome measures
| Measure |
PMDD Patients
n=15 Participants
PMDD patients
|
Healthy Controls
n=14 Participants
Healthy Controls
|
|---|---|---|
|
Hormone Analysis
-20 minute timepoint
|
70.7 ng/mL
Standard Deviation 26.4
|
57.8 ng/mL
Standard Deviation 21.9
|
|
Hormone Analysis
+20 minute timepoint
|
114 ng/mL
Standard Deviation 53.4
|
97.3 ng/mL
Standard Deviation 39.9
|
|
Hormone Analysis
+30 minute timepoint
|
111 ng/mL
Standard Deviation 43.6
|
109 ng/mL
Standard Deviation 43.6
|
|
Hormone Analysis
+40 minute timepoint
|
97 ng/mL
Standard Deviation 48.9
|
100 ng/mL
Standard Deviation 32.4
|
|
Hormone Analysis
+50 minute timepoint
|
86.9 ng/mL
Standard Deviation 39.4
|
93.3 ng/mL
Standard Deviation 29.2
|
|
Hormone Analysis
+65 minute timepoint
|
73.5 ng/mL
Standard Deviation 31.6
|
78.4 ng/mL
Standard Deviation 24
|
|
Hormone Analysis
+90 minute timepoint
|
70.6 ng/mL
Standard Deviation 36.6
|
69 ng/mL
Standard Deviation 18.5
|
Adverse Events
Total
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place