Trial Outcomes & Findings for Maintaining Suppression of Testosterone With Transdermal Estradiol Gel (NCT NCT02349386)
NCT ID: NCT02349386
Last Updated: 2022-03-31
Results Overview
Primary Efficacy Endpoint was the percentage of patients failing to maintain castrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Week 12
Results posted on
2022-03-31
Participant Flow
Participant milestones
| Measure |
BHR-200 Low Dose
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
24-Week Double-Blind Main Study
STARTED
|
9
|
8
|
9
|
8
|
|
24-Week Double-Blind Main Study
COMPLETED
|
3
|
2
|
4
|
0
|
|
24-Week Double-Blind Main Study
NOT COMPLETED
|
6
|
6
|
5
|
8
|
|
28-Week Double-Blind Optional Extension
STARTED
|
3
|
2
|
4
|
0
|
|
28-Week Double-Blind Optional Extension
COMPLETED
|
1
|
2
|
1
|
0
|
|
28-Week Double-Blind Optional Extension
NOT COMPLETED
|
2
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
BHR-200 Low Dose
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
24-Week Double-Blind Main Study
Adverse Event
|
0
|
0
|
1
|
1
|
|
24-Week Double-Blind Main Study
Lack of Efficacy
|
6
|
6
|
2
|
7
|
|
24-Week Double-Blind Main Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
24-Week Double-Blind Main Study
Patient underwent transurethral resection of prostate (exclusionary procedure)
|
0
|
0
|
1
|
0
|
|
28-Week Double-Blind Optional Extension
Lack of Efficacy
|
2
|
0
|
2
|
0
|
|
28-Week Double-Blind Optional Extension
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Maintaining Suppression of Testosterone With Transdermal Estradiol Gel
Baseline characteristics by cohort
| Measure |
BHR-200 Low Dose
n=9 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=9 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=8 Participants
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
34 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The Intent-to-treat (ITT) population contains all patients who are randomized into the study. All efficacy parameters were analyzed using the ITT population. In the case of a patient who was randomized but did not take the study drug, the analysis was done for this patient using the randomized treatment.
Primary Efficacy Endpoint was the percentage of patients failing to maintain castrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12.
Outcome measures
| Measure |
BHR-200 Low Dose
n=8 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=8 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=7 Participants
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Maintenance of Testosterone Suppression at Week 12
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The Intent-to-treat (ITT) population contains all patients who are randomized into the study. All efficacy parameters were analyzed using the ITT population. In the case of a patient who was randomized but did not take the study drug, the analysis was done for this patient using the randomized treatment.
Pproportion of patients failing to maintaincastrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 24.
Outcome measures
| Measure |
BHR-200 Low Dose
n=8 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=5 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=6 Participants
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Maintenance of Testosterone Suppression at Week 24
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension StudyPopulation: Safety Population
Number of patients and severity of thromboembolic adverse events
Outcome measures
| Measure |
BHR-200 Low Dose
n=9 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=9 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=8 Participants
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Number of Patients Reporting Thromboembolic Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48Population: Safety population: contains all patients who received at least one dose of study drug.
Serum concentrations of luteinizing hormone (LH)
Outcome measures
| Measure |
BHR-200 Low Dose
n=9 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=9 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=8 Participants
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Luteinizing Hormone (LH)
Baseline LH
|
0.380 IU/L
Standard Deviation 0.5700
|
0.470 IU/L
Standard Deviation 0.5949
|
0.190 IU/L
Standard Deviation 0.0000
|
0.530 IU/L
Standard Deviation 0.9576
|
|
Luteinizing Hormone (LH)
Week 12 LH
|
0.227 IU/L
Standard Deviation 0.0635
|
0.527 IU/L
Standard Deviation 0.5831
|
1.597 IU/L
Standard Deviation 2.1889
|
2.050 IU/L
Standard Deviation 2.1920
|
|
Luteinizing Hormone (LH)
Week 24 LH
|
0.997 IU/L
Standard Deviation 0.7267
|
0.395 IU/L
Standard Deviation 0.2899
|
0.393 IU/L
Standard Deviation 0.4050
|
—
|
|
Luteinizing Hormone (LH)
Week 36 LH
|
0.645 IU/L
Standard Deviation 0.6435
|
0.345 IU/L
Standard Deviation 0.2192
|
3.750 IU/L
Standard Deviation 4.7376
|
—
|
|
Luteinizing Hormone (LH)
Week 48 LH
|
0.600 IU/L
Standard Deviation 0
|
0.300 IU/L
Standard Deviation 0.1414
|
0.300 IU/L
Standard Deviation 0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48Population: Safety population: contains all patients who received at least one dose of study drug.
Serum concentrations of sex hormone binding globulin (SHBG)
Outcome measures
| Measure |
BHR-200 Low Dose
n=9 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=9 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=8 Participants
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Sex Hormone Binding Globulin (SHBG)
Week 24 SHBG
|
50.3 nmol/L
Standard Deviation 15.63
|
52.0 nmol/L
Standard Deviation 4.24
|
71.3 nmol/L
Standard Deviation 8.62
|
—
|
|
Sex Hormone Binding Globulin (SHBG)
Week 36 SHBG
|
37.0 nmol/L
Standard Deviation 7.07
|
53.5 nmol/L
Standard Deviation 3.54
|
47.0 nmol/L
Standard Deviation 12.73
|
—
|
|
Sex Hormone Binding Globulin (SHBG)
Week 48 SHBG
|
46.0 nmol/L
Standard Deviation 0
|
42.5 nmol/L
Standard Deviation 7.78
|
58.0 nmol/L
Standard Deviation 0
|
—
|
|
Sex Hormone Binding Globulin (SHBG)
Baseline SHBG
|
49.7 nmol/L
Standard Deviation 17.65
|
52.8 nmol/L
Standard Deviation 22.48
|
45.8 nmol/L
Standard Deviation 15.64
|
48.8 nmol/L
Standard Deviation 24.09
|
|
Sex Hormone Binding Globulin (SHBG)
Week 12 SHBG
|
48.7 nmol/L
Standard Deviation 18.01
|
55.7 nmol/L
Standard Deviation 3.06
|
55.2 nmol/L
Standard Deviation 10.62
|
27.0 nmol/L
Standard Deviation 2.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension StudyPopulation: Safety population: contains all patients who received at least one dose of study drug.
Serum concentrations of prostate specific antigen (PSA)
Outcome measures
| Measure |
BHR-200 Low Dose
n=9 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=9 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=8 Participants
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Prostate Specific Antigen (PSA)
Baseline PSA
|
0.374 ng/ML
Standard Deviation 0.4572
|
0.921 ng/ML
Standard Deviation 1.1726
|
8.058 ng/ML
Standard Deviation 22.2814
|
0.334 ng/ML
Standard Deviation 0.5623
|
|
Prostate Specific Antigen (PSA)
Week 4 PSA
|
0.459 ng/ML
Standard Deviation 0.6234
|
1.483 ng/ML
Standard Deviation 2.2501
|
5.170 ng/ML
Standard Deviation 13.1114
|
0.481 ng/ML
Standard Deviation 0.6153
|
|
Prostate Specific Antigen (PSA)
Week 8 PSA
|
0.545 ng/ML
Standard Deviation 0.7978
|
1.145 ng/ML
Standard Deviation 1.6158
|
4.995 ng/ML
Standard Deviation 12.0050
|
0.870 ng/ML
Standard Deviation 0.9449
|
|
Prostate Specific Antigen (PSA)
Week 12 PSA
|
0.330 ng/ML
Standard Deviation 0.3251
|
0.227 ng/ML
Standard Deviation 0.2367
|
4.380 ng/ML
Standard Deviation 10.4936
|
1.395 ng/ML
Standard Deviation 1.8455
|
|
Prostate Specific Antigen (PSA)
Week 16 PSA
|
0.297 ng/ML
Standard Deviation 0.2684
|
0.160 ng/ML
Standard Deviation 0.1212
|
6.960 ng/ML
Standard Deviation 11.8992
|
0.090 ng/ML
Standard Deviation 0
|
|
Prostate Specific Antigen (PSA)
Week 20 PSA
|
0.330 ng/ML
Standard Deviation 0.3251
|
0.127 ng/ML
Standard Deviation 0.0635
|
5.345 ng/ML
Standard Deviation 10.5033
|
—
|
|
Prostate Specific Antigen (PSA)
Week 24 PSA
|
0.363 ng/ML
Standard Deviation 0.3099
|
0.145 ng/ML
Standard Deviation 0.0778
|
4.745 ng/ML
Standard Deviation 9.3033
|
—
|
|
Prostate Specific Antigen (PSA)
Week 28 PSA
|
0.430 ng/ML
Standard Deviation 0.3110
|
0.090 ng/ML
Standard Deviation 0
|
4.863 ng/ML
Standard Deviation 8.2590
|
—
|
|
Prostate Specific Antigen (PSA)
Week 32 PSA
|
0.463 ng/ML
Standard Deviation 0.3272
|
0.145 ng/ML
Standard Deviation 0.0778
|
4.563 ng/ML
Standard Deviation 7.7394
|
—
|
|
Prostate Specific Antigen (PSA)
Week 36 PSA
|
0.650 ng/ML
Standard Deviation 0.0707
|
0.145 ng/ML
Standard Deviation 0.0778
|
7.050 ng/ML
Standard Deviation 9.5459
|
—
|
|
Prostate Specific Antigen (PSA)
Week 40 PSA
|
0.750 ng/ML
Standard Deviation 0.2121
|
0.145 ng/ML
Standard Deviation 0.0778
|
7.800 ng/ML
Standard Deviation 0
|
—
|
|
Prostate Specific Antigen (PSA)
Week 44 PSA
|
0.500 ng/ML
Standard Deviation 0
|
0.145 ng/ML
Standard Deviation 0.0778
|
12.600 ng/ML
Standard Deviation 0
|
—
|
|
Prostate Specific Antigen (PSA)
Week 48 PSA
|
0.700 ng/ML
Standard Deviation 0
|
0.145 ng/ML
Standard Deviation 0.0778
|
12.800 ng/ML
Standard Deviation 0
|
—
|
|
Prostate Specific Antigen (PSA)
Week 52 PSA
|
0.700 ng/ML
Standard Deviation 0
|
0.145 ng/ML
Standard Deviation 0.0778
|
13.300 ng/ML
Standard Deviation 0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48Population: Safety population: contains all patients who received at least one dose of study drug.
Serum concentrations of follicle-stimulating hormone (FSH)
Outcome measures
| Measure |
BHR-200 Low Dose
n=9 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=8 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=8 Participants
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Follicle-stimulating Hormone (FSH)
Baseline FSH
|
4.478 IU/L
Standard Deviation 1.9911
|
5.225 IU/L
Standard Deviation 1.8093
|
3.963 IU/L
Standard Deviation 2.1354
|
5.700 IU/L
Standard Deviation 2.0901
|
|
Follicle-stimulating Hormone (FSH)
Week 12 FSH
|
0.630 IU/L
Standard Deviation 0.2339
|
0.493 IU/L
Standard Deviation 0.0058
|
3.848 IU/L
Standard Deviation 5.0343
|
9.450 IU/L
Standard Deviation 5.4447
|
|
Follicle-stimulating Hormone (FSH)
Week 24 FSH
|
1.600 IU/L
Standard Deviation 0.9165
|
0.795 IU/L
Standard Deviation 0.4313
|
0.848 IU/L
Standard Deviation 0.5219
|
—
|
|
Follicle-stimulating Hormone (FSH)
Week 36 FSH
|
2.050 IU/L
Standard Deviation 1.3435
|
1.095 IU/L
Standard Deviation 0.8556
|
10.600 IU/L
Standard Deviation 12.7279
|
—
|
|
Follicle-stimulating Hormone (FSH)
Week 48 FSH
|
2.00 IU/L
Standard Deviation 0
|
0.795 IU/L
Standard Deviation 0.4313
|
1.500 IU/L
Standard Deviation 0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Double-blind 28-Week Optional Extension Study from Week 24 to Week 52/End of StudyPopulation: Intent-to-Treat
Proportion of patients failing to maintain castrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 24 to 52/End of Study
Outcome measures
| Measure |
BHR-200 Low Dose
n=3 Participants
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=2 Participants
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=4 Participants
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Maintenance of Testosterone Suppression at Week 52/ End of Study
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
BHR-200 Low Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BHR-200 Mid Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BHR-200 High Dose
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BHR-200 Low Dose
n=9 participants at risk
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 participants at risk
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=9 participants at risk
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=8 participants at risk
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • Number of events 1 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Surgical and medical procedures
Lymphoid tissue operation
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • Number of events 1 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
Other adverse events
| Measure |
BHR-200 Low Dose
n=9 participants at risk
3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 Mid Dose
n=8 participants at risk
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
BHR-200 High Dose
n=9 participants at risk
9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
|
Placebo
n=8 participants at risk
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Eye disorders
Diplopia
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
22.2%
2/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
General disorders
Application site pain
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
22.2%
2/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Investigations
Blood pressure increased
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Reproductive system and breast disorders
Breast tenderness
|
22.2%
2/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
37.5%
3/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Reproductive system and breast disorders
Nipple pain
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
33.3%
3/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Reproductive system and breast disorders
Breast enlargement
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Surgical and medical procedures
Lymphoid tissue operation
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
12.5%
1/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
22.2%
2/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
|
Vascular disorders
Hot flush
|
11.1%
1/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/9 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
0.00%
0/8 • AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
|
Additional Information
Global Chief Medical Officer
Besins Healthcare Ireland Ltd
Phone: +353 87 1039215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place