Trial Outcomes & Findings for Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men (NCT NCT01200862)
NCT ID: NCT01200862
Last Updated: 2020-10-08
Results Overview
Percentage of patients achieving normal testosterone (2.50 - 9.50 ng/mL) levels at Week 4 and Week 12
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
At Week 4 and 12
Results posted on
2020-10-08
Participant Flow
14 participants enrolled in Part 1 and 15 participants enrolled in part 2.
Participant milestones
| Measure |
BGS649 Part 1
BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
|
BGS649 Part 2
BGS649 0.3mg hard gelatin capsule given orally on Day 1 and 0.1mg BGS649 capsule on other treatment visits (week 1 to 11).
|
Placebo to BGS649
Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
|
|---|---|---|---|
|
Part 1
STARTED
|
14
|
0
|
0
|
|
Part 1
COMPLETED
|
13
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
1
|
0
|
0
|
|
Part 2
STARTED
|
0
|
7
|
8
|
|
Part 2
COMPLETED
|
0
|
6
|
8
|
|
Part 2
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Part 1 and Part 2 results were analysed completed separately throughout the study
Baseline characteristics by cohort
| Measure |
BGS649 (Part 1)
n=14 Participants
BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
|
BGS649 (Part 2)
n=7 Participants
BGS649 0.3mg hard gelatin capsule given orally on Day 1 and 0.1mg BGS649 capsule on other treatment visits (week 1 to 11).
|
Placebo to BGS649 (Part 2)
n=8 Participants
Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age (Part 1)
|
50 years
STANDARD_DEVIATION 9.54 • n=14 Participants • Part 1 and Part 2 results were analysed completed separately throughout the study
|
—
|
—
|
50 years
STANDARD_DEVIATION 10.1 • n=14 Participants • Part 1 and Part 2 results were analysed completed separately throughout the study
|
|
Age, Continuous
Age (Part 2)
|
—
|
51 years
STANDARD_DEVIATION 10.1 • n=7 Participants • Part 1 and Part 2 results were analysed completed separately throughout the study
|
50 years
STANDARD_DEVIATION 11.1 • n=8 Participants • Part 1 and Part 2 results were analysed completed separately throughout the study
|
50 years
STANDARD_DEVIATION 10.3 • n=15 Participants • Part 1 and Part 2 results were analysed completed separately throughout the study
|
|
Sex: Female, Male
Sex (Part 1) · Female
|
0 Participants
n=14 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
—
|
—
|
0 Participants
n=14 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
|
Sex: Female, Male
Sex (Part 1) · Male
|
14 Participants
n=14 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
—
|
—
|
14 Participants
n=14 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
|
Sex: Female, Male
Sex (Part 2) · Female
|
—
|
0 Participants
n=7 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
0 Participants
n=8 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
0 Participants
n=15 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
|
Sex: Female, Male
Sex (Part 2) · Male
|
—
|
7 Participants
n=7 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
8 Participants
n=8 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
15 Participants
n=15 Participants • Part 1 and Part 2 patients were analysed completed separately throughout the study
|
|
Race/Ethnicity, Customized
Part 1 · Caucasian
|
12 Participants
n=14 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
—
|
—
|
12 Participants
n=14 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
|
Race/Ethnicity, Customized
Part 1 · Black
|
2 Participants
n=14 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
—
|
—
|
2 Participants
n=14 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
|
Race/Ethnicity, Customized
Part 1 · Native American
|
0 Participants
n=14 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
—
|
—
|
0 Participants
n=14 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
|
Race/Ethnicity, Customized
Part 2 · Caucasian
|
—
|
6 Participants
n=7 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
7 Participants
n=8 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
13 Participants
n=15 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
|
Race/Ethnicity, Customized
Part 2 · Black
|
—
|
0 Participants
n=7 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
1 Participants
n=8 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
1 Participants
n=15 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
|
Race/Ethnicity, Customized
Part 2 · Native American
|
—
|
1 Participants
n=7 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
0 Participants
n=8 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
1 Participants
n=15 Participants • Part 1 and Part 2 of the study were reported/analysed separately and so combined totals are not available
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
7 participants
n=7 Participants
|
8 participants
n=8 Participants
|
29 participants
n=29 Participants
|
|
Body Mass Index
BMI (Part 1)
|
34 kg/m2
STANDARD_DEVIATION 3.21 • n=14 Participants • Part A and Part B were analysed and reported separately in the study
|
—
|
—
|
36.6 kg/m2
STANDARD_DEVIATION 4.10 • n=14 Participants • Part A and Part B were analysed and reported separately in the study
|
|
Body Mass Index
BMI (Part 2)
|
—
|
37 kg/m2
STANDARD_DEVIATION 2.9 • n=7 Participants • Part A and Part B were analysed and reported separately in the study
|
39 kg/m2
STANDARD_DEVIATION 6.2 • n=8 Participants • Part A and Part B were analysed and reported separately in the study
|
38 kg/m2
STANDARD_DEVIATION 4.9 • n=15 Participants • Part A and Part B were analysed and reported separately in the study
|
PRIMARY outcome
Timeframe: At Week 4 and 12Population: Number/percentage of patients achieving normal sex hormone levels at Week 4 and Week 12 (Part 1 Only)
Percentage of patients achieving normal testosterone (2.50 - 9.50 ng/mL) levels at Week 4 and Week 12
Outcome measures
| Measure |
BGS649 (Part 1)
n=14 Participants
BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
|
Placebo to BGS649
Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
|
|---|---|---|
|
Percentage of Patients Achieving Normal Testosterone Levels
Week 4
|
14 Participants
|
—
|
|
Percentage of Patients Achieving Normal Testosterone Levels
Week 12
|
13 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: Could not be analysed due to drug administration errors. Week 12 data is missing because they were inaccuracies in the dosing of patients and so the study was terminated early and efficacy data not reported for the affected patients.
Pharmacodynamic change from baseline in HOMA-IR. Score at week 4 and week 12 as an assessment of insulin resistance. Low score representing high insulin sensitivity and a high score representing low insulin sensitivity or insulin resistance. HOMA-IR is a ration of Fasting insulin (mIU/L) : Fasting glucose (mmol). Pharmacodynamic change in QUICKI score at week 4 and week 12 as an assessment of insulin resistance. The QUICKI scale is a log score and a high score representing high insulin sensitivity and low score indicating low insulin sensitivity. Patients with a score below 0.3 are considered diabetic. Week 12 data is missing because there were inaccuracies in dosing of patients and so the study was terminated, only safety data was collected.
Outcome measures
| Measure |
BGS649 (Part 1)
n=7 Participants
BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
|
Placebo to BGS649
n=5 Participants
Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
|
|---|---|---|
|
Part 2: Change From Baseline at Homeostatic Model Assessment of Insulin Resistance (HOMA-IR & QUICKI Scores) at Week 4 and 12
HOMA-IR at 4 weeks
|
7.94 units on a scale
Interval 3.72 to 16.92
|
7.45 units on a scale
Interval 2.74 to 20.29
|
|
Part 2: Change From Baseline at Homeostatic Model Assessment of Insulin Resistance (HOMA-IR & QUICKI Scores) at Week 4 and 12
QUICKI at 4 weeks
|
0.12 units on a scale
Interval 0.11 to 0.14
|
0.13 units on a scale
Interval 0.11 to 0.14
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: PK Analysis Set included 7 patients given BGS649 in Part 2.
PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11. The AUC 0-168 measures the amount of drug within the subjects blood over the 168h post-dosing at these timepoints.
Outcome measures
| Measure |
BGS649 (Part 1)
n=7 Participants
BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
|
Placebo to BGS649
Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve From Time Zero to Time 't' (AUC0-168)
Week 1
|
114 ng*hr/mL
Standard Deviation 36.9
|
—
|
|
Part 2: Area Under the Concentration-time Curve From Time Zero to Time 't' (AUC0-168)
Week 4
|
152 ng*hr/mL
Standard Deviation 48.8
|
—
|
|
Part 2: Area Under the Concentration-time Curve From Time Zero to Time 't' (AUC0-168)
Week 11
|
167 ng*hr/mL
Standard Deviation 21.5
|
—
|
SECONDARY outcome
Timeframe: Week 1 to Week 11Population: PK Analysis Set
PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11.
Outcome measures
| Measure |
BGS649 (Part 1)
n=7 Participants
BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
|
Placebo to BGS649
Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
|
|---|---|---|
|
Part 2: Pharmacokinetics of BGS649: Maximum (Peak) Observed Blood Drug Concentration After Single Dose Administration (Cmax)
Week 1
|
2.83 ng/mL
Standard Deviation 0.998
|
—
|
|
Part 2: Pharmacokinetics of BGS649: Maximum (Peak) Observed Blood Drug Concentration After Single Dose Administration (Cmax)
Week 4
|
1.69 ng/mL
Standard Deviation 0.610
|
—
|
|
Part 2: Pharmacokinetics of BGS649: Maximum (Peak) Observed Blood Drug Concentration After Single Dose Administration (Cmax)
Week 11
|
1.69 ng/mL
Standard Deviation 0.261
|
—
|
SECONDARY outcome
Timeframe: Week 1 to Week 11Population: PK Population
PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11.
Outcome measures
| Measure |
BGS649 (Part 1)
n=7 Participants
BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
|
Placebo to BGS649
Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
|
|---|---|---|
|
Part 2: Pharmacokinetics of BGS649: Time to Reach Maximum (Peak) Blood Drug Concentration After Single Dose Administration (Tmax)
Week 1
|
1.02 hours
Standard Deviation 0.00339
|
—
|
|
Part 2: Pharmacokinetics of BGS649: Time to Reach Maximum (Peak) Blood Drug Concentration After Single Dose Administration (Tmax)
Week 4
|
1.01 hours
Standard Deviation 0.0136
|
—
|
|
Part 2: Pharmacokinetics of BGS649: Time to Reach Maximum (Peak) Blood Drug Concentration After Single Dose Administration (Tmax)
Week 11
|
0.993 hours
Standard Deviation 0.0450
|
—
|
SECONDARY outcome
Timeframe: Week 1 to Week 11Population: PK Analysis Set. Sparse PK sampling (4 samples over 672 h) was included for the PK profile for Week 4; Cmax was included in λz estimation, therefore T1/2 was not reported for all profiles in Week 4.
PK sampling was performed at 0hr (pre-dose), 1 hr, 8 hr, 24 hr, 72 hr, and 168 hr on the following occasions Week 1, Week 4 and week 11.
Outcome measures
| Measure |
BGS649 (Part 1)
n=7 Participants
BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided.
|
Placebo to BGS649
Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11).
|
|---|---|---|
|
PK of BGS649 Elimination Half-life Associated With the Terminal Slope of a Semi Logarithmic Concentration-time Curve (T1/2)
Week 1
|
474 hours
Standard Deviation 114
|
—
|
|
PK of BGS649 Elimination Half-life Associated With the Terminal Slope of a Semi Logarithmic Concentration-time Curve (T1/2)
Week 11
|
489 hours
Standard Deviation 83
|
—
|
Adverse Events
BGS649 (Part 1) Open Label
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
BGS649 (Part 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo to BGS649 (Part 2)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BGS649 (Part 1) Open Label
n=14 participants at risk
Individualised doses to titrate testosterone levels to within normal range. Doses ranged between 0.003mg and 5mg in total over the 11 week treatment period. For doses below 0.1mg, separate pharmacy instructions were provided to dilute an oral solution of BGS649.
|
BGS649 (Part 2)
n=7 participants at risk
All subjects were given 0.3mg on Day 1 and then 0.1mg on all other dosing visits (weeks 2-11).
|
Placebo to BGS649 (Part 2)
n=8 participants at risk
Matching placebo capsules on Day 1 and all other dosing visits (weeks 2-11).
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
Other adverse events
| Measure |
BGS649 (Part 1) Open Label
n=14 participants at risk
Individualised doses to titrate testosterone levels to within normal range. Doses ranged between 0.003mg and 5mg in total over the 11 week treatment period. For doses below 0.1mg, separate pharmacy instructions were provided to dilute an oral solution of BGS649.
|
BGS649 (Part 2)
n=7 participants at risk
All subjects were given 0.3mg on Day 1 and then 0.1mg on all other dosing visits (weeks 2-11).
|
Placebo to BGS649 (Part 2)
n=8 participants at risk
Matching placebo capsules on Day 1 and all other dosing visits (weeks 2-11).
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Number of events 3 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Gastrointestinal disorders
Frequent bowel movements
|
14.3%
2/14 • Number of events 2 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • Number of events 4 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
28.6%
2/7 • Number of events 2 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Number of events 2 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
2/14 • Number of events 2 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
28.6%
4/14 • Number of events 4 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
21.4%
3/14 • Number of events 3 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Reproductive system and breast disorders
Oropharyngeal pain
|
21.4%
3/14 • Number of events 3 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Nervous system disorders
Amnesia
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
25.0%
2/8 • Number of events 2 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Metabolism and nutrition disorders
Increased appetitie
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Reproductive system and breast disorders
Libido increased
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Nervous system disorders
Night sweats
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
General disorders
Pain
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Nervous system disorders
Pyrexia
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
14.3%
1/7 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
25.0%
2/8 • Number of events 2 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Nervous system disorders
Stress
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Nervous system disorders
Terminal insomnia
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Blood and lymphatic system disorders
Thrombosis
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
General disorders
Vaccination site pain
|
7.1%
1/14 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/8 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
0.00%
0/7 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
12.5%
1/8 • Number of events 1 • 16 weeks
Does not differ to clinicaltrials.gov. definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All PIs must seek written permission from the sponsor prior to publication of any trial results.
- Publication restrictions are in place
Restriction type: OTHER