Trial Outcomes & Findings for Effects of DHEA in Pulmonary Hypertension (NCT NCT03648385)
NCT ID: NCT03648385
Last Updated: 2025-11-05
Results Overview
Longitudinal strain is determined using standard cine imaging and Tissue Tracking (Strain) software (Tissue Tracking plugin, Circle Cardiovascular Imaging). Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. 2D RV longitudinal strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)
Results posted on
2025-11-05
Participant Flow
Participant milestones
| Measure |
DHEA to Placebo
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
Following washout period of 4 weeks. Placebo (1 tablet once a day) for 18 weeks
|
Placebo to DHEA
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of DHEA in Pulmonary Hypertension
Baseline characteristics by cohort
| Measure |
DHEA to placebo
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=15 Participants
|
8 Participants
n=161 Participants
|
20 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
6 Participants
n=100 Participants
|
|
Age, Continuous
|
44 years
n=15 Participants
|
54 years
n=161 Participants
|
48 years
n=100 Participants
|
|
Sex: Female, Male
Total · Female
|
10 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
12 Participants
n=100 Participants
|
|
Sex: Female, Male
Total · Male
|
4 Participants
n=15 Participants
|
10 Participants
n=161 Participants
|
14 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=15 Participants
|
11 Participants
n=161 Participants
|
22 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=15 Participants
|
9 Participants
n=161 Participants
|
19 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
6 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=15 Participants
|
12 participants
n=161 Participants
|
26 participants
n=100 Participants
|
|
BMI
|
32 kg/m2
n=15 Participants
|
34 kg/m2
n=161 Participants
|
32 kg/m2
n=100 Participants
|
|
6MWD
|
437 meters
n=15 Participants
|
420 meters
n=161 Participants
|
430 meters
n=100 Participants
|
|
Functional Class
II
|
11 Participants
n=15 Participants
|
8 Participants
n=161 Participants
|
19 Participants
n=100 Participants
|
|
Functional Class
III
|
3 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
7 Participants
n=100 Participants
|
|
PAH Diagnosis
Idiopathic
|
5 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
PAH Diagnosis
Heritable
|
3 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
5 Participants
n=100 Participants
|
|
PAH Diagnosis
Drug and Toxin
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
PAH Diagnosis
Connective Tissue Disease
|
5 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
9 Participants
n=100 Participants
|
|
PAH Diagnosis
Congenital Heart Disease
|
1 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
EmPHasis10
|
25 units on a scale
n=15 Participants
|
19 units on a scale
n=161 Participants
|
25 units on a scale
n=100 Participants
|
|
Mean PAP
|
43 mmHg
n=15 Participants
|
50 mmHg
n=161 Participants
|
45 mmHg
n=100 Participants
|
|
N-terminal proBNP, pg/mL
|
79.9 pg/mL
n=15 Participants
|
193.2 pg/mL
n=161 Participants
|
127.6 pg/mL
n=100 Participants
|
|
Right atrial pressure, mmHg
|
7 mmHg
n=15 Participants
|
10 mmHg
n=161 Participants
|
10 mmHg
n=100 Participants
|
|
PAOP, mm Hg
|
11 mmHg
n=15 Participants
|
13 mmHg
n=161 Participants
|
11 mmHg
n=100 Participants
|
|
PVR, Wood units
|
5 woods units
n=15 Participants
|
8 woods units
n=161 Participants
|
6 woods units
n=100 Participants
|
|
Cardiac Index L/min/m^2
|
2.9 L/min/m^2
n=15 Participants
|
2.7 L/min/m^2
n=161 Participants
|
2.8 L/min/m^2
n=100 Participants
|
|
Short-Form 36 PCS
|
38 units on a scale
n=15 Participants
|
45 units on a scale
n=161 Participants
|
40 units on a scale
n=100 Participants
|
|
Short-Form 36 MCS
|
48 units on a scale
n=15 Participants
|
54 units on a scale
n=161 Participants
|
49 units on a scale
n=100 Participants
|
|
RV Longitudinal Strain, %
|
-18.4 %
n=15 Participants
|
-18.8 %
n=161 Participants
|
-18.8 %
n=100 Participants
|
|
RV peak global radial strain, %
|
22.4 %
n=15 Participants
|
18.9 %
n=161 Participants
|
20 %
n=100 Participants
|
|
RV circumferential strain, %
|
-14.8 %
n=15 Participants
|
-12.2 %
n=161 Participants
|
-13.3 %
n=100 Participants
|
|
†RV radial strain, %
|
22.4 %
n=15 Participants
|
18.9 %
n=161 Participants
|
20 %
n=100 Participants
|
|
RVEF, %
|
55 %
n=15 Participants
|
51 %
n=161 Participants
|
53 %
n=100 Participants
|
|
RVEDV, mL
|
147 mL
n=15 Participants
|
181 mL
n=161 Participants
|
163 mL
n=100 Participants
|
|
RVESV, mL
|
62 mL
n=15 Participants
|
92 mL
n=161 Participants
|
71 mL
n=100 Participants
|
|
RV stroke volume, mL
|
82 mL
n=15 Participants
|
83 mL
n=161 Participants
|
82 mL
n=100 Participants
|
|
RV mass, g
|
55 grams
n=15 Participants
|
55 grams
n=161 Participants
|
55 grams
n=100 Participants
|
PRIMARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Population: All patients receive both DHEA and placebo during this crossover study. One group received DHEA first, followed by a washout period, then placebo. The second group received placebo first, followed by a washout period, then DHEA.
Longitudinal strain is determined using standard cine imaging and Tissue Tracking (Strain) software (Tissue Tracking plugin, Circle Cardiovascular Imaging). Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. 2D RV longitudinal strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Right Ventricular (RV) Longitudinal Strain, % Cardiac Magnetic Resonance Imaging (MRI)
|
-16.7 % Change in RV Longitudinal Strain
Interval -19.1 to -14.3
|
-16.8 % Change in RV Longitudinal Strain
Interval -21.36 to -12.18
|
-16.9 % Change in RV Longitudinal Strain
Interval -19.06 to -14.68
|
-17.7 % Change in RV Longitudinal Strain
Interval -19.9 to -15.5
|
-18.3 % Change in RV Longitudinal Strain
Interval -20.5 to -16.0
|
-17.2 % Change in RV Longitudinal Strain
Interval -19.7 to -14.7
|
PRIMARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)†Short axis, RV radial strain, % by Cardiac Magnetic Resonance Imaging (MRI). Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. Measurements were made using CVI42, Circle Cardiovascular Imaging. 2D RV longitudinal strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Right Ventricular (RV) †RV Radial Strain, %,
|
23.1 % Change in RV radial strain
Interval 19.5 to 26.7
|
22.2 % Change in RV radial strain
Interval 18.7 to 25.66
|
19.1 % Change in RV radial strain
Interval 16.03 to 22.06
|
21.1 % Change in RV radial strain
Interval 18.1 to 24.0
|
20.7 % Change in RV radial strain
Interval 16.7 to 24.6
|
19.3 % Change in RV radial strain
Interval 16.5 to 22.2
|
PRIMARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Circumferential strain is determined using standard cine imaging and Tissue Tracking (Strain) software (Tissue Tracking plugin, Circle Cardiovascular Imaging). Cardiac Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. Measurements were made using CVI42, Circle Cardiovascular Imaging. 2D RV circumferential strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positive, which indicates lengthening, or negative, which indicates shortening. Normal circumferential and longitudinal strain are negative numbers, those for radial strain are positive.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
†RV Circumferential Strain, %
|
-14.4 % Change in RV circumferential strain
Interval -16.2 to -12.6
|
-14.3 % Change in RV circumferential strain
Interval -15.94 to -12.58
|
-12.3 % Change in RV circumferential strain
Interval -13.93 to -10.63
|
-13.7 % Change in RV circumferential strain
Interval -15.2 to -12.2
|
-13.3 % Change in RV circumferential strain
Interval -15.5 to -12.2
|
-12.8 % Change in RV circumferential strain
Interval -14.4 to -11.3
|
PRIMARY outcome
Timeframe: 18 Weeks, 40 Weeks% Change in RV End Diastolic Volume (RVEDV), mL by Cardiac Magnetic Resonance Imaging (MRI), strain from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
RV End Diastolic Volume (RVEDV), mL
|
161.3 mL
Interval 129.8 to 200.4
|
156.7 mL
Interval 133.7 to 183.86
|
173.8 mL
Interval 140.19 to 215.47
|
160.4 mL
Interval 137.3 to 187.4
|
159.8 mL
Interval 130.1 to 196.3
|
161.4 mL
Interval 134.9 to 193.1
|
PRIMARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in RV ejection fraction measured by Cardiac Magnetic Resonance Imaging (MRI), % Change in strain from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex. Ventricular EFs are calculated by dividing respective stroke volumes (EDV-ESV) by EDVs.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in RV Ejection Fraction Measured by Cardiac MRI
|
49.2 % Change in RV ejection fraction
Interval 43.8 to 54.6
|
52.1 % Change in RV ejection fraction
Interval 47.0 to 57.1
|
49.4 % Change in RV ejection fraction
Interval 43.9 to 55.0
|
52.6 % Change in RV ejection fraction
Interval 47.0 to 58.2
|
50.3 % Change in RV ejection fraction
Interval 44.8 to 55.7
|
50.7 % Change in RV ejection fraction
Interval 46.1 to 55.4
|
PRIMARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in right ventricular end-systolic volume from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
RVESV, mL
|
81.1 mL
Interval 61.7 to 106.6
|
73.6 mL
Interval 57.4 to 94.4
|
86.6 mL
Interval 65.6 to 114.26
|
74.2 mL
Interval 57.6 to 95.7
|
78.1 mL
Interval 59.3 to 102.9
|
78.2 mL
Interval 60.7 to 100.9
|
PRIMARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Right ventricular stroke volume by cardiac MRI from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Stroke volume is calculated through breath-hold through-plane phase contrast imaging with a velocity encoding gradient (VENC) of \<120 cm/s (larger if aliasing present) in the main PA \~2-3 cm above the pulmonary valve plane, with imaging plane oriented orthogonal to the main PA. Free-breathing phase contrast imaging in the same plane and VENC with averaging over 4 respiratory cycles.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
RV Stroke Volume, mL
|
77.7 mL
Interval 62.9 to 95.9
|
80.1 mL
Interval 73.7 to 87.0
|
83.9 mL
Interval 68.64 to 102.6
|
81.6 mL
Interval 72.0 to 92.3
|
80.3 mL
Interval 66.9 to 96.3
|
80.9 mL
Interval 70.9 to 92.4
|
PRIMARY outcome
Timeframe: 18 weeks, 40 weeksRight ventricular mass, Change in RV mass from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex. RV mass is determined at the end-diastole phase as the difference between end-diastolic epicardial and endocardial volumes X heart specific gravity (1.05 g/cm3).
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
RV Mass, g
|
54.1 g
Interval 42.4 to 69.2
|
58.8 g
Interval 46.16 to 74.9
|
55.7 g
Interval 44.66 to 69.4
|
58.2 g
Interval 45.2 to 74.9
|
52.2 g
Interval 42.3 to 64.4
|
55.9 g
Interval 45.1 to 69.3
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in 6MWD from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Six Minute Walk Distance (6MWD) Between DHEA and Placebo
|
364.6 meters
Interval 268.6 to 495.0
|
433.58 meters
Interval 375.4 to 500.7
|
355.2 meters
Interval 266.8 to 472.9
|
428.3 meters
Interval 379.2 to 483.9
|
356.2 meters
Interval 263.4 to 481.7
|
402.1 meters
Interval 323.0 to 500.4
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in WHO Functional Class (I - IV with IV indicating worse symptoms) between DHEA and placebo.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in World Health Organization (WHO) Functional Class
|
2.3 score on a scale
Interval 2.1 to 2.6
|
2.2 score on a scale
Interval 2.0 to 2.4
|
2.3 score on a scale
Interval 2.1 to 2.6
|
2.2 score on a scale
Interval 2.0 to 2.4
|
2.4 score on a scale
Interval 2.1 to 2.7
|
2.1 score on a scale
Interval 1.8 to 2.4
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Short Form-36 summary scores for physical and mental components (range 0 - 100, higher scores indicating better quality of life).
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Short Form-36 Summary Scores for Physical and Mental Components
SF-36, PCS
|
41.7 score on a scale
Interval 37.0 to 46.4
|
39.4 score on a scale
Interval 36.0 to 42.7
|
42.8 score on a scale
Interval 38.4 to 47.2
|
39.7 score on a scale
Interval 36.2 to 43.1
|
38.9 score on a scale
Interval 32.6 to 45.3
|
37.0 score on a scale
Interval 32.2 to 41.8
|
|
Change in Short Form-36 Summary Scores for Physical and Mental Components
SF-36, MCS
|
47.9 score on a scale
Interval 40.8 to 54.9
|
45.1 score on a scale
Interval 37.1 to 53.1
|
49.1 score on a scale
Interval 41.8 to 56.3
|
43.6 score on a scale
Interval 37.1 to 50.2
|
46.2 score on a scale
Interval 39.5 to 53.0
|
45.2 score on a scale
Interval 38.8 to 51.5
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in emPHasis-10 score (range 0 - 50, higher scores indicating worse quality of life) between DHEA and placebo.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in emPHasis-10
|
18.1 score on a scale
Interval 11.8 to 24.3
|
25.4 score on a scale
Interval 20.8 to 29.9
|
21.7 score on a scale
Interval 13.9 to 29.5
|
25.5 score on a scale
Interval 20.7 to 30.3
|
22.7 score on a scale
Interval 16.1 to 29.4
|
27.3 score on a scale
Interval 21.0 to 33.6
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in serum level of NT-proBNP between DHEA and placebo.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in NT-proBNP Between DHEA and Placebo
|
146.9 pg/mL
Interval 77.2 to 279.9
|
106.8 pg/mL
Interval 75.5 to 151.2
|
205.9 pg/mL
Interval 105.8 to 400.6
|
156.4 pg/mL
Interval 103.5 to 236.2
|
139.3 pg/mL
Interval 70.0 to 289.9
|
170.3 pg/mL
Interval 88.5 to 327.7
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in DHEA-S from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in DHEA-S (ug/dL)
|
169.9 ug/dL
Interval 87.0 to 332.0
|
77.8 ug/dL
Interval 49.0 to 123.8
|
48.2 ug/dL
Interval 26.6 to 87.5
|
287.8 ug/dL
Interval 197.5 to 419.3
|
49.3 ug/dL
Interval 28.2 to 86.1
|
75.9 ug/dL
Interval 55.0 to 104.6
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Estradiol, pg/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Estradiol, pg/mL
|
25.3 pg/mL
Interval 14.3 to 44.8
|
46.3 pg/mL
Interval 22.9 to 93.6
|
26.3 pg/mL
Interval 13.9 to 49.7
|
60.7 pg/mL
Interval 33.0 to 111.7
|
24.7 pg/mL
Interval 11.2 to 54.3
|
34.5 pg/mL
Interval 18.0 to 66.3
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Testosterone, ng/dL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Testosterone, ng/dL
|
35.3 ng/dL
Interval 14.2 to 87.7
|
23.8 ng/dL
Interval 9.0 to 62.7
|
10.2 ng/dL
Interval 3.8 to 27.3
|
65.6 ng/dL
Interval 37.3 to 115.4
|
10.4 ng/dL
Interval 3.7 to 29.3
|
27 ng/dL
Interval 10.8 to 67.4
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Progesterone, ng/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Progesterone, ng/mL
|
0.4 ng/mL
Interval 0.2 to 0.6
|
0.6 ng/mL
Interval 0.4 to 1.0
|
0.6 ng/mL
Interval 0.3 to 1.3
|
0.6 ng/mL
Interval 0.3 to 0.9
|
0.4 ng/mL
Interval 0.3 to 0.6
|
0.8 ng/mL
Interval 0.4 to 1.6
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in FSH, mIU/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Follicle Stimulating Hormone (FSH), mIU/mL
|
25.5 mIU/mL
Interval 14.7 to 44.2
|
11.3 mIU/mL
Interval 6.7 to 18.9
|
21.5 mIU/mL
Interval 11.8 to 39.1
|
9.7 mIU/mL
Interval 5.7 to 16.6
|
23.5 mIU/mL
Interval 13.0 to 42.7
|
9.4 mIU/mL
Interval 5.4 to 16.7
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in SHBG, nmol/L from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Sex Hormone Binding Globulin (SHBG), Nmol/L
|
48 nmol/L
Interval 34.2 to 67.5
|
57.8 nmol/L
Interval 41.7 to 79.9
|
61 nmol/L
Interval 44.2 to 84.21
|
50.2 nmol/L
Interval 38.1 to 66.1
|
62.2 nmol/L
Interval 44.2 to 87.4
|
59.3 nmol/L
Interval 43.1 to 81.6
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Luteinizing hormone, mIU/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Luteinizing Hormone, mIU/mL
|
17.5 mIU/mL
Interval 11.8 to 26.1
|
12.5 mIU/mL
Interval 7.9 to 12.5
|
14.3 mIU/mL
Interval 8.4 to 24.3
|
10.3 mIU/mL
Interval 6.3 to 16.7
|
14.5 mIU/mL
Interval 8.3 to 25.4
|
8.6 mIU/mL
Interval 4.7 to 15.6
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Prolactin, μIU/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Prolactin, μIU/mL
|
271.4 μIU/mL
Interval 190.1 to 387.6
|
329.5 μIU/mL
Interval 274.8 to 395.1
|
287.8 μIU/mL
Interval 206.4 to 401.1
|
327.4 μIU/mL
Interval 256.2 to 418.2
|
293.8 μIU/mL
Interval 212.6 to 406.1
|
305.2 μIU/mL
Interval 267.3 to 348.5
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in C-peptide, ng/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in C-peptide, ng/mL
|
3.4 ng/mL
Interval 2.5 to 4.6
|
3.3 ng/mL
Interval 2.5 to 4.5
|
3.6 ng/mL
Interval 2.5 to 5.3
|
3.1 ng/mL
Interval 2.3 to 4.1
|
3.3 ng/mL
Interval 2.3 to 4.7
|
3 ng/mL
Interval 2.3 to 4.0
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Insulin, μU/mL from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Change in Insulin, μU/mL
|
13.5 μU/mL
Interval 8.0 to 22.8
|
11.4 μU/mL
Interval 7.5 to 17.4
|
13.2 μU/mL
Interval 7.5 to 23.4
|
10.7 μU/mL
Interval 6.7 to 17.0
|
12.1 μU/mL
Interval 7.2 to 20.2
|
10.8 μU/mL
Interval 7.1 to 16.4
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Cortisol, μg/dL\^2 (micrograms per deciliter squared) from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Cortisol, μg/dL^2
|
11.7 μg/dL^2
Interval 9.7 to 14.4
|
11.7 μg/dL^2
Interval 8.9 to 15.4
|
9.1 μg/dL^2
Interval 6.8 to 12.1
|
9.2 μg/dL^2
Interval 6.7 to 12.8
|
12.6 μg/dL^2
Interval 10.3 to 15.4
|
12.9 μg/dL^2
Interval 9.9 to 16.6
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in left ventricular ejection fraction (%) measured by Cardiac Magnetic Resonance Imaging (MRI). Change in LVEG from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex was used.. Ventricular EFs are calculated by dividing respective stroke volumes (EDV-ESV) by EDVs. Normal Values: 56-78% for both males and females.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Left Ventricular Ejection Fraction, %
|
73.4 % Change in LVEF
Interval 68.6 to 77.6
|
66.2 % Change in LVEF
Interval 58.3 to 73.3
|
71.8 % Change in LVEF
Interval 67.2 to 75.9
|
69.1 % Change in LVEF
Interval 65.4 to 72.6
|
71.4 % Change in LVEF
Interval 66.5 to 75.8
|
68.4 % Change in LVEF
Interval 65.0 to 71.7
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in left ventricular LVEDV measured by Cardiac Magnetic Resonance Imaging (MRI). Change in LVEDV from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap. Normal values (Male):77-195 ml. Normal values (female):58-154 ml.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Left Ventricular End-diastolic Volume (LVEDV) (mL)
|
101 mL
Interval 87.2 to 117.1
|
104.9 mL
Interval 94.8 to 116.1
|
109.9 mL
Interval 95.5 to 126.4
|
107.7 mL
Interval 94.8 to 122.4
|
102.7 mL
Interval 87.0 to 121.3
|
105.3 mL
Interval 90.7 to 122.3
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in LVESV measured by Cardiac Magnetic Resonance Imaging (MRI). Change in LVEDV from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging was obtained from the base of the heart through the apex. The endocardial and epicardial borders of both ventricles are be traced manually on short axis cine images at end-diastole and end-systole with exclusion of the papillary muscles and trabeculae. EDV and ESV are calculated using Simpson's rule by summation of areas on each slice multiplied by the sum of slice thickness and image gap. Normal Values (Female):13-51 ml. Normal values (Male):19-72 ml
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Left Ventricular End-systolic Volume (LVESV) (mL)
|
26.1 mL
Interval 19.9 to 34.4
|
31 mL
Interval 25.8 to 37.2
|
31.4 mL
Interval 23.7 to 41.5
|
32.7 mL
Interval 26.7 to 40.0
|
30.5 mL
Interval 22.1 to 42.1
|
32.5 mL
Interval 25.8 to 41.1
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Left ventricular stroke volume measured by Cardiac Magnetic Resonance Imaging (MRI). Change in Left ventricular stroke volume from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Stroke volume is calculated through breath-hold through-plane phase contrast imaging with a velocity encoding gradient (VENC) of \<120 cm/s (larger if aliasing present) in the main PA \~2-3 cm above the pulmonary valve plane, with imaging plane oriented orthogonal to the main PA. Free-breathing phase contrast imaging in the same plane and VENC with averaging over 4 respiratory cycles.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Left Ventricular Stroke Volume (mL)
|
72.2 mL
Interval 62.6 to 83.2
|
72.8 mL
Interval 66.8 to 79.3
|
78.4 mL
Interval 68.0 to 90.4
|
74.0 mL
Interval 65.9 to 83.2
|
75.5 mL
Interval 65.7 to 86.6
|
71.5 mL
Interval 62.6 to 81.6
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks (treatment period 1), 18 weeks to 40 weeks (treatment period 2)Change in Left ventricular end diastolic mass, g measured by Cardiac Magnetic Resonance Imaging (MRI). Change in Left ventricular end diastolic mass, g from baseline to 18 weeks (treatment period 1) and 18 week to 40 weeks (treatment period 2) in both groups: DHEA to Placebo (DHEA taken first, followed by washout and then Placebo) and Placebo to DHEA (placebo taken first, followed by washout and then DHEA). Short-axis steady state free precession (SSFP) imaging from the base of the heart through the apex. LV mass is determined at the end-diastole phase as the difference between end-diastolic epicardial and endocardial volumes X heart specific gravity (1.05 g/cm3).
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
n=12 Participants
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
n=12 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
n=14 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Left Ventricular End Diastolic Mass, g
|
114 g
Interval 100.2 to 129.7
|
117.8 g
Interval 97.0 to 143.0
|
119.3 g
Interval 102.5 to 138.9
|
122.2 g
Interval 104.3 to 143.2
|
119.5 g
Interval 104.5 to 136.6
|
116.6 g
Interval 98.8 to 137.7
|
SECONDARY outcome
Timeframe: 18 weeks, 40 weeksPopulation: Data shown as n (%) of all adverse events during DHEA, placebo or the washout period. Includes only events that occurred ≥ 2 times during the study. \*Specifically queried at each study visit.
Treatment-related side effects and adverse events (as assessed by CTCAE v4.0). All participants in this trial received both DHEA and Placebo during the trial, therefore, side-effects and adverse events are listed according to the treatment or washout period in which they occurred.
Outcome measures
| Measure |
Placebo to DHEA, 40 weeks
Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks
|
DHEA to Placebo Baseline
n=26 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA Baseline
n=26 Participants
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 18 Weeks
n=26 Participants
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
Placebo to DHEA, 18 weeks
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
then
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
|
DHEA to Placebo, 40 weeks
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 week
then
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
|---|---|---|---|---|---|---|
|
Treatment-related Side Effects and Adverse Events
Catheter related infection
|
—
|
2 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Seborrhoea
|
—
|
3 participants
|
1 participants
|
1 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Hair Growth
|
—
|
2 participants
|
0 participants
|
1 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Diarrhea
|
—
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Dizziness
|
—
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Dry skin
|
—
|
1 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Hypokalemia
|
—
|
2 participants
|
0 participants
|
0 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Peripheral swelling
|
—
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Pruritis
|
—
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Rash
|
—
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Sepsis
|
—
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Hair Loss
|
—
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Headache
|
—
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
|
Treatment-related Side Effects and Adverse Events
Acne
|
—
|
6 participants
|
0 participants
|
0 participants
|
—
|
—
|
Adverse Events
DHEA
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
DHEA Washout
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Washout
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DHEA
n=26 participants at risk
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
|
Placebo
n=26 participants at risk
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
DHEA Washout
n=26 participants at risk
Washout Period between Placebo and DHEA
|
Placebo Washout
n=26 participants at risk
Washout Period DHEA and Placebo
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
10016450
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Musculoskeletal and connective tissue disorders
10053206
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Musculoskeletal and connective tissue disorders
10073974
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10056871
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10060842
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Blood and lymphatic system disorders
10040047
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Endocrine disorders
10020850
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
11.5%
3/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Blood and lymphatic system disorders
10002272
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Product Issues
10007810
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10038695
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Gastrointestinal disorders
10000081
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Infections and infestations
10084268
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
General disorders
10042772
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Blood and lymphatic system disorders
10002034
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Nervous system disorders
10039911
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
Other adverse events
| Measure |
DHEA
n=26 participants at risk
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
DHEA tablet: DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
|
Placebo
n=26 participants at risk
1 placebo tablet taken by mouth once a day for 18 weeks
Placebo: 1 placebo tablet taken by mouth once a day for 18 weeks
|
DHEA Washout
n=26 participants at risk
Washout Period between Placebo and DHEA
|
Placebo Washout
n=26 participants at risk
Washout Period DHEA and Placebo
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
10000147
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10000496
|
19.2%
5/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10001760
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Psychiatric disorders
10002856
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Cardiac disorders
10003664
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Immune system disorders
10003875
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Musculoskeletal and connective tissue disorders
10003988
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10006373
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Infections and infestations
10007810
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10007909
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Infections and infestations
10009851
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Gastrointestinal disorders
10012727
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Eye disorders
10013036
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Ear and labyrinth disorders
10013573
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Ear and labyrinth disorders
10013582
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Eye disorders
10013774
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10013786
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Vascular disorders
10013877
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Gastrointestinal disorders
10014542
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10015573
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Eye disorders
10015988
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Infections and infestations
10016791
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Gastrointestinal disorders
10016952
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Gastrointestinal disorders
10017853
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10019044
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10019045
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Nervous system disorders
10019211
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Blood and lymphatic system disorders
10019428
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10019523
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Blood and lymphatic system disorders
10021018
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10021143
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Nervous system disorders
10021282
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10021680
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Psychiatric disorders
10022437
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10023086
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Eye disorders
10023090
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Musculoskeletal and connective tissue disorders
10023222
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Nervous system disorders
10027192
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
General disorders
10028050
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
General disorders
10029410
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Musculoskeletal and connective tissue disorders
10033411
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Musculoskeletal and connective tissue disorders
10033432
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Cardiac disorders
10033557
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10033733
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Cardiac disorders
10034474
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
General disorders
10036653
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10037402
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10037844
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10039792
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10040604
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
General disorders
10042702
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Infections and infestations
10046300
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Reproductive system and breast disorders
10046901
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Vascular disorders
10047115
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10049201
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10049498
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Eye disorders
10051626
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Product Issues
10051792
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Blood and lymphatic system disorders
10056739
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10059294
|
7.7%
2/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Skin and subcutaneous tissue disorders
10059295
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Product Issues
10073974
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
Respiratory, thoracic and mediastinal disorders
10077730
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
|
General disorders
10080818
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
3.8%
1/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
0.00%
0/26 • Adverse event data was collected at 2 weeks, 18 weeks, 19 weeks, 22 weeks, 24 weeks, 40 weeks and 42 weeks
|
Additional Information
Corey Ventetuolo, MD
Brown University Health, Center for Advanced Lung Care
Phone: 401-444-2733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place