Trial Outcomes & Findings for A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene (NCT NCT02651688)
NCT ID: NCT02651688
Last Updated: 2019-06-27
Results Overview
LBM was assessed using dual-energy X-ray absorptiometry (DXA). A positive change from Baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline (Day 0) to Week 48
Results posted on
2019-06-27
Participant Flow
Participant milestones
| Measure |
Enclomiphene 12.5 mg
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
15
|
|
Overall Study
COMPLETED
|
16
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
3
|
Reasons for withdrawal
| Measure |
Enclomiphene 12.5 mg
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Overall Study
Non-compliance
|
0
|
0
|
1
|
|
Overall Study
Principal Investigator (PI) decision
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
Baseline Characteristics
Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
Baseline characteristics by cohort
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
n=18 Participants • Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
|
44.9 years
n=17 Participants • Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
|
44.9 years
n=15 Participants • Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
|
44.0 years
n=50 Participants • Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
|
|
Sex/Gender, Customized
Male
|
18 Participants
n=18 Participants • Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
|
17 Participants
n=17 Participants • Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
|
15 Participants
n=15 Participants • Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
|
50 Participants
n=50 Participants • Safety population included all participants who received at least one treatment (with either enclomiphene or placebo).
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: Intent to treat (ITT) population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
LBM was assessed using dual-energy X-ray absorptiometry (DXA). A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Lean Body Mass (LBM) at Week 48
Baseline
|
65.23 kg
Standard Deviation 7.08
|
65.60 kg
Standard Deviation 7.88
|
68.12 kg
Standard Deviation 7.43
|
|
Change From Baseline in Lean Body Mass (LBM) at Week 48
Change from Baseline to week 48
|
3.14 kg
Standard Deviation 4.03
|
2.40 kg
Standard Deviation 3.54
|
1.05 kg
Standard Deviation 4.10
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Body Strength (Chest Press Weight) at Week 48
Baseline
|
169.00 pounds (lbs)
Standard Deviation 56.46
|
180.93 pounds (lbs)
Standard Deviation 95.43
|
151.50 pounds (lbs)
Standard Deviation 63.68
|
|
Change From Baseline in Body Strength (Chest Press Weight) at Week 48
Change from Baseline to Week 48
|
75.00 pounds (lbs)
Standard Deviation 28.80
|
76.90 pounds (lbs)
Standard Deviation 51.55
|
87.27 pounds (lbs)
Standard Deviation 50.61
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Body Strength (Leg Press Weight) at Week 48
Baseline
|
466.06 pounds (lbs)
Standard Deviation 291.7
|
464.20 pounds (lbs)
Standard Deviation 288.2
|
580.86 pounds (lbs)
Standard Deviation 264.2
|
|
Change From Baseline in Body Strength (Leg Press Weight) at Week 48
Change from Baseline to Week 48
|
406.92 pounds (lbs)
Standard Deviation 222.2
|
323.80 pounds (lbs)
Standard Deviation 200.3
|
351.50 pounds (lbs)
Standard Deviation 216.2
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter LH measured in milli-International Units per milliliter (mIU/mL). A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48
Baseline
|
3.93 mIU/mL
Standard Deviation 1.82
|
3.41 mIU/mL
Standard Deviation 0.93
|
3.51 mIU/mL
Standard Deviation 1.31
|
|
Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48
Change from Baseline to Week 48
|
2.40 mIU/mL
Standard Deviation 3.39
|
3.01 mIU/mL
Standard Deviation 4.70
|
0.83 mIU/mL
Standard Deviation 1.25
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter T. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Testosterone (T) Level at Week 48
Baseline
|
243.56 ng/dL
Standard Deviation 55.03
|
218.24 ng/dL
Standard Deviation 43.39
|
223.53 ng/dL
Standard Deviation 58.01
|
|
Change From Baseline in Blood Testosterone (T) Level at Week 48
Change from Baseline to Week 48
|
173.81 ng/dL
Standard Deviation 130.7
|
237.17 ng/dL
Standard Deviation 181.4
|
43.33 ng/dL
Standard Deviation 59.50
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter DHT. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48
Baseline
|
18.78 nanogram per deciliter (ng/dL)
Standard Deviation 7.74
|
16.06 nanogram per deciliter (ng/dL)
Standard Deviation 5.76
|
15.73 nanogram per deciliter (ng/dL)
Standard Deviation 5.92
|
|
Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48
Change from Baseline to Week 48
|
15.13 nanogram per deciliter (ng/dL)
Standard Deviation 12.92
|
20.75 nanogram per deciliter (ng/dL)
Standard Deviation 15.21
|
4.25 nanogram per deciliter (ng/dL)
Standard Deviation 5.96
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter E2. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Estradiol (E2) Level at Week 48
Baseline
|
50.04 pg/mL
Standard Deviation 16.80
|
48.43 pg/mL
Standard Deviation 15.15
|
45.49 pg/mL
Standard Deviation 12.05
|
|
Change From Baseline in Blood Estradiol (E2) Level at Week 48
Change from Baseline to Week 48
|
-3.00 pg/mL
Standard Deviation 28.02
|
13.03 pg/mL
Standard Deviation 26.20
|
-11.46 pg/mL
Standard Deviation 15.41
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
The T:E2 ratio was calculated as the value of T/value of E2 using the same units. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48
Baseline
|
5.26 ratio
Standard Deviation 1.73
|
4.93 ratio
Standard Deviation 1.96
|
5.21 ratio
Standard Deviation 1.88
|
|
Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48
Change from Baseline to Week 48
|
5.11 ratio
Standard Deviation 7.57
|
2.89 ratio
Standard Deviation 3.09
|
2.85 ratio
Standard Deviation 3.36
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
The DHT:T ratio was calculated as the value of DHT/value of T using the same units. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48
Baseline
|
0.08 ratio
Standard Deviation 0.02
|
0.08 ratio
Standard Deviation 0.03
|
0.07 ratio
Standard Deviation 0.03
|
|
Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48
Change from Baseline to Week 48
|
0.01 ratio
Standard Deviation 0.03
|
0.00 ratio
Standard Deviation 0.02
|
0.00 ratio
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter HbA1c. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48
Baseline
|
5.56 percentage of HbA1c
Standard Deviation 0.35
|
5.95 percentage of HbA1c
Standard Deviation 0.74
|
5.77 percentage of HbA1c
Standard Deviation 0.32
|
|
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48
Change from Baseline to Week 48
|
-0.34 percentage of HbA1c
Standard Deviation 0.37
|
-0.54 percentage of HbA1c
Standard Deviation 0.27
|
-0.65 percentage of HbA1c
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter Glucose. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Glucose Level at Week 48
Baseline
|
98.39 pg/mL
Standard Deviation 14.71
|
101.41 pg/mL
Standard Deviation 10.69
|
97.93 pg/mL
Standard Deviation 13.22
|
|
Change From Baseline in Blood Glucose Level at Week 48
Change from Baseline to Week 48
|
-1.81 pg/mL
Standard Deviation 16.69
|
-5.25 pg/mL
Standard Deviation 8.70
|
-4.33 pg/mL
Standard Deviation 13.29
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter CRP. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48
Baseline
|
0.25 mg/dL
Standard Deviation 0.22
|
0.35 mg/dL
Standard Deviation 0.41
|
0.35 mg/dL
Standard Deviation 0.35
|
|
Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48
Change from Baseline to Week 48
|
0.06 mg/dL
Standard Deviation 0.50
|
-0.05 mg/dL
Standard Deviation 0.29
|
-0.15 mg/dL
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter IL-6. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48
Baseline
|
2.23 pg/mL
Standard Deviation 0.98
|
3.38 pg/mL
Standard Deviation 1.76
|
2.75 pg/mL
Standard Deviation 1.25
|
|
Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48
Change from Baseline to Week 48
|
0.56 pg/mL
Standard Deviation 1.55
|
-0.21 pg/mL
Standard Deviation 1.50
|
-0.78 pg/mL
Standard Deviation 1.57
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter TNF-α . A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48
Baseline
|
1.77 pg/mL
Standard Deviation 0.68
|
1.93 pg/mL
Standard Deviation 1.19
|
1.94 pg/mL
Standard Deviation 0.84
|
|
Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48
Change from Baseline to Week 48
|
-0.63 pg/mL
Standard Deviation 0.69
|
-0.35 pg/mL
Standard Deviation 0.88
|
-0.70 pg/mL
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter leptin. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Leptin Level at Week 48
Baseline
|
9.88 ng/mL
Standard Deviation 4.64
|
16.55 ng/mL
Standard Deviation 9.14
|
15.16 ng/mL
Standard Deviation 4.65
|
|
Change From Baseline in Blood Leptin Level at Week 48
Change from Baseline to Week 48
|
1.14 ng/mL
Standard Deviation 5.81
|
2.63 ng/mL
Standard Deviation 12.10
|
-2.27 ng/mL
Standard Deviation 11.27
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
The HOMA-IR is the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/mL) × fasting plasma glucose (mmol/L)/22.5. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48
Baseline
|
4.88 units on a scale
Standard Deviation 3.59
|
4.99 units on a scale
Standard Deviation 2.92
|
4.74 units on a scale
Standard Deviation 2.16
|
|
Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48
Change from Baseline to Week 48
|
-1.14 units on a scale
Standard Deviation 4.50
|
-0.75 units on a scale
Standard Deviation 3.17
|
-1.80 units on a scale
Standard Deviation 2.01
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
Quantose-IR is a laboratory-developed test that assesses insulin resistance. Quantose-IR score is based on a linear regression algorithm utilizing the quantitative measures (natural log transformed) of alpha-hydroxybutyrate, oleate, linoleoylglycerophosphocholine and insulin and was designed to estimate the natural log of insulin-induced glucose infusion rate normalized by whole body mass. The algorithm score is converted to the Quantose-IR score within a range of 1-120 by an arithmetic calculation where higher scores denote greater insulin resistance. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48
Baseline
|
75.74 Quantose-IR score
Standard Deviation 11.98
|
76.50 Quantose-IR score
Standard Deviation 8.40
|
78.05 Quantose-IR score
Standard Deviation 12.41
|
|
Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48
Change from Baseline to Week 48
|
-3.96 Quantose-IR score
Standard Deviation 10.65
|
-6.59 Quantose-IR score
Standard Deviation 17.41
|
-6.50 Quantose-IR score
Standard Deviation 13.71
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
BMI is calculated as weight (kg)/height(cm\^2). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI) at Week 48
Change from Baseline to Week 48
|
-1.43 kg/cm^2
Standard Deviation 3.27
|
-2.29 kg/cm^2
Standard Deviation 2.78
|
-4.38 kg/cm^2
Standard Deviation 2.94
|
|
Change From Baseline in Body Mass Index (BMI) at Week 48
Baseline
|
35.45 kg/cm^2
Standard Deviation 3.01
|
37.38 kg/cm^2
Standard Deviation 3.62
|
38.05 kg/cm^2
Standard Deviation 2.63
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Waist Circumference at Week 48
Baseline
|
115.34 cm
Standard Deviation 7.12
|
120.87 cm
Standard Deviation 10.89
|
123.96 cm
Standard Deviation 12.09
|
|
Change From Baseline in Waist Circumference at Week 48
Change from Baseline to Week 48
|
-6.71 cm
Standard Deviation 6.68
|
-6.52 cm
Standard Deviation 13.04
|
-12.62 cm
Standard Deviation 10.59
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 48Population: ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.
A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Enclomiphene 12.5 mg
n=18 Participants
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 Participants
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 Participants
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Change From Baseline in Weight at Week 48
Baseline
|
114.13 kg
Standard Deviation 11.31
|
121.75 kg
Standard Deviation 13.76
|
124.58 kg
Standard Deviation 10.96
|
|
Change From Baseline in Weight at Week 48
Change from Baseline to Week 48
|
-4.36 kg
Standard Deviation 9.95
|
-6.15 kg
Standard Deviation 9.46
|
-14.51 kg
Standard Deviation 10.34
|
Adverse Events
Enclomiphene 12.5 mg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Enclomiphene 25 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enclomiphene 12.5 mg
n=18 participants at risk
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 participants at risk
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 participants at risk
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Vascular disorders
Ischaemic stroke
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
Other adverse events
| Measure |
Enclomiphene 12.5 mg
n=18 participants at risk
Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Enclomiphene 25 mg
n=17 participants at risk
Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
Placebo
n=15 participants at risk
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
|
|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Gastrointestinal disorders
Abdominal hernia
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Gastrointestinal disorders
Umbilical hernia
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
General disorders
Asthenia
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
General disorders
Chest discomfort
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
General disorders
Night sweats
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
2/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
11.8%
2/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Infections and infestations
Coxsackie viral infection
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Infections and infestations
Gastroenteritis viral
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
13.3%
2/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Infections and infestations
Viral pharyngitis
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Infections and infestations
Food poisoning
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Investigations
Electrocardiogram abnormal
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Investigations
Haematocrit increased
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Investigations
Heart rate increased
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
13.3%
2/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
20.0%
3/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Nervous system disorders
Seizure
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Psychiatric disorders
Irritability
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Psychiatric disorders
Panic attack
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Reproductive system and breast disorders
Prostatomegaly
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Skin and subcutaneous tissue disorders
Laceration
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
5.9%
1/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Surgical and medical procedures
Vasectomy
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Vascular disorders
Haemorrhoids
|
5.6%
1/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
0.00%
0/17 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
6.7%
1/15 • From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER