Trial Outcomes & Findings for Sex Differences in the Dilatory Response of Compound 21 (NCT NCT05576155)
NCT ID: NCT05576155
Last Updated: 2024-12-31
Results Overview
cutaneous vascular vasodilator response to exogenous Compound 21 perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of Compound 21 in young men and women
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
26 participants
Primary outcome timeframe
post 1 hour of local control treatment
Results posted on
2024-12-31
Participant Flow
Participant milestones
| Measure |
Young Men
Young men aged 18-35
|
Young Women
Premenopausal women aged 18-35
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Young Men
Young men aged 18-35
|
Young Women
Premenopausal women aged 18-35
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Sex Differences in the Dilatory Response of Compound 21
Baseline characteristics by cohort
| Measure |
Young Men
n=12 Participants
Young men aged 18-35
|
Young Women
n=12 Participants
Premenopausal women aged 18-35
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 5 • n=5 Participants
|
22 years
STANDARD_DEVIATION 3 • n=7 Participants
|
22 years
STANDARD_DEVIATION 24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Heart rate
|
59 bpm
STANDARD_DEVIATION 11 • n=5 Participants
|
64 bpm
STANDARD_DEVIATION 11 • n=7 Participants
|
62 bpm
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Mean Arterial Pressure
|
82 mmHg
STANDARD_DEVIATION 6 • n=5 Participants
|
79 mmHg
STANDARD_DEVIATION 6 • n=7 Participants
|
80 mmHg
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Body Mass Index
|
25 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
|
24 kg/m^2
STANDARD_DEVIATION 2 • n=7 Participants
|
24 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
|
PRIMARY outcome
Timeframe: post 1 hour of local control treatmentcutaneous vascular vasodilator response to exogenous Compound 21 perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of Compound 21 in young men and women
Outcome measures
| Measure |
Young Men
n=12 Participants
Young men aged 18-35
|
Young Women
n=12 Participants
Premenopausal women aged 18-35
|
|---|---|---|
|
Microvascular AT2R Sensitivity Following Local Control Treatment
|
15 percentage of maximal blood flow
Standard Error 2
|
25 percentage of maximal blood flow
Standard Error 4
|
PRIMARY outcome
Timeframe: post 1 hour of local losartan treatmentcutaneous vascular vasodilator response to exogenous Compound 21 perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of Compound 21 co-infused with losartan young men and women
Outcome measures
| Measure |
Young Men
n=12 Participants
Young men aged 18-35
|
Young Women
n=12 Participants
Premenopausal women aged 18-35
|
|---|---|---|
|
Microvascular AT2R Sensitivity Following Local AT1R Inhibition
|
26 percentage of maximal blood flow
Standard Error 4
|
27 percentage of maximal blood flow
Standard Error 6
|
SECONDARY outcome
Timeframe: at the start of the experimental visit, immediately prior to local losartan treatmentplasma measurement of circulating progesterone and testosterone; measured by ELISA in plasma samples
Outcome measures
| Measure |
Young Men
n=10 Participants
Young men aged 18-35
|
Young Women
n=8 Participants
Premenopausal women aged 18-35
|
|---|---|---|
|
Circulating Progesterone and Testosterone
Progesterone
|
0.9 ng/mL
Standard Deviation 0.8
|
0.7 ng/mL
Standard Deviation 0.4
|
|
Circulating Progesterone and Testosterone
Testosterone
|
1029.4 ng/mL
Standard Deviation 556.1
|
174.1 ng/mL
Standard Deviation 97.4
|
SECONDARY outcome
Timeframe: at the start of the experimental visit, immediately prior to local losartan treatmentplasma measurement of circulating estradiol, measured by ELISA in plasma samples
Outcome measures
| Measure |
Young Men
n=10 Participants
Young men aged 18-35
|
Young Women
n=8 Participants
Premenopausal women aged 18-35
|
|---|---|---|
|
Circulating Estradiol
|
134.1 pg/mL
Standard Deviation 83.4
|
138.5 pg/mL
Standard Deviation 133.1
|
Adverse Events
Young Men
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Young Women
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