Trial Outcomes & Findings for Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men (NCT NCT01699178)
NCT ID: NCT01699178
Last Updated: 2021-06-28
Results Overview
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
COMPLETED
PHASE3
182 participants
Approximately 365 days
2021-06-28
Participant Flow
Participant milestones
| Measure |
Oral Testosterone Undecanoate
Oral testosterone undecanoate 100-300 mg T BID, for 12 months.
|
Transdermal Testosterone Gel (AndroGel)
Transdermal testosterone gel 2.5-10 g/applied once daily for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
94
|
|
Overall Study
COMPLETED
|
69
|
62
|
|
Overall Study
NOT COMPLETED
|
19
|
32
|
Reasons for withdrawal
| Measure |
Oral Testosterone Undecanoate
Oral testosterone undecanoate 100-300 mg T BID, for 12 months.
|
Transdermal Testosterone Gel (AndroGel)
Transdermal testosterone gel 2.5-10 g/applied once daily for 12 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
|
Overall Study
Non-compliance with Study Drug
|
3
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
12
|
|
Overall Study
Hematocrit >54%
|
1
|
1
|
|
Overall Study
PSA increase of >1.4 ng/mL
|
4
|
3
|
|
Overall Study
ineligible/noncompliant/ subject reason
|
4
|
4
|
Baseline Characteristics
Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
Baseline characteristics by cohort
| Measure |
Oral Testosterone Undecanoate
n=88 Participants
Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.
Oral testosterone undecanoate: Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
|
Transdermal Testosterone Gel (AndroGel)
n=94 Participants
Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months
Transdermal testosterone gel (AndroGel): Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 10.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=5 Participants
|
94 participants
n=7 Participants
|
182 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 365 daysPopulation: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Outcome measures
| Measure |
Oral TU
n=68 Participants
Subjects treated with Oral TU
|
Transdermal T-gel
n=62 Participants
Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.
|
|---|---|---|
|
Absolute Change From Baseline in T Cholesterol
|
0.2 mg/dL
Interval -8.4 to 8.9
|
8.2 mg/dL
Interval -0.1 to 16.6
|
PRIMARY outcome
Timeframe: Approximately 365 daysPopulation: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Outcome measures
| Measure |
Oral TU
n=68 Participants
Subjects treated with Oral TU
|
Transdermal T-gel
n=62 Participants
Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.
|
|---|---|---|
|
Absolute Change From Baseline in HDL
|
2.4 mg/dL
Interval 0.7 to 4.1
|
4.0 mg/dL
Interval 2.5 to 5.5
|
PRIMARY outcome
Timeframe: Approximately 365 daysPopulation: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Outcome measures
| Measure |
Oral TU
n=67 Participants
Subjects treated with Oral TU
|
Transdermal T-gel
n=61 Participants
Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.
|
|---|---|---|
|
Absolute Change From Baseline in LDL
|
-1.5 mg/dL
Interval -9.5 to 6.5
|
6.0 mg/dL
Interval -1.2 to 13.1
|
PRIMARY outcome
Timeframe: Approximately 365 daysPopulation: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Outcome measures
| Measure |
Oral TU
n=68 Participants
Subjects treated with Oral TU
|
Transdermal T-gel
n=62 Participants
Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.
|
|---|---|---|
|
Absolute Change From Baseline in Hgb
|
0.36 g/dL
Interval 0.11 to 0.61
|
0.36 g/dL
Interval 0.07 to 0.65
|
PRIMARY outcome
Timeframe: Approximately 365 daysPopulation: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Outcome measures
| Measure |
Oral TU
n=68 Participants
Subjects treated with Oral TU
|
Transdermal T-gel
n=62 Participants
Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.
|
|---|---|---|
|
Absolute Change From Baseline in Hct
|
0.38 percent
Interval -0.3 to 1.06
|
0.37 percent
Interval -0.44 to 1.19
|
PRIMARY outcome
Timeframe: Approximately 365 daysPopulation: The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.
Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Outcome measures
| Measure |
Oral TU
n=68 Participants
Subjects treated with Oral TU
|
Transdermal T-gel
n=61 Participants
Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment.
|
|---|---|---|
|
Absolute Change From Baseline in Prostate Volume
|
1.09 cc
Interval -0.78 to 2.97
|
0.40 cc
Interval -1.81 to 2.62
|
Adverse Events
Oral TU
Transdermal T-gel
Serious adverse events
| Measure |
Oral TU
n=88 participants at risk
Subjects treated with Oral TU with a measurement taken after approximately 365 days of treatment are used for safety laboratory values for comparisons to baseline. All subjects who received at least one dose of study drug were included in the reporting of treatment emergent adverse events.
|
Transdermal T-gel
n=94 participants at risk
Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment are used for safety laboratory values for comparisons to baseline. All subjects who received at least one dose of study drug were included in the reporting of treatment emergent adverse events.
|
|---|---|---|
|
Cardiac disorders
Prinzmetal angina
|
1.1%
1/88 • Number of events 1 • 365 days
|
0.00%
0/94 • 365 days
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/88 • 365 days
|
1.1%
1/94 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
gastric ulcer hemorrhage
|
0.00%
0/88 • 365 days
|
1.1%
1/94 • Number of events 1 • 365 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/88 • Number of events 1 • 365 days
|
0.00%
0/94 • 365 days
|
|
Infections and infestations
sepsis
|
0.00%
0/88 • 365 days
|
1.1%
1/94 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/88 • 365 days
|
1.1%
1/94 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
wound
|
1.1%
1/88 • Number of events 1 • 365 days
|
0.00%
0/94 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
1.1%
1/88 • Number of events 1 • 365 days
|
0.00%
0/94 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/88 • 365 days
|
1.1%
1/94 • Number of events 1 • 365 days
|
|
Nervous system disorders
Cerebellar Infarction
|
1.1%
1/88 • Number of events 1 • 365 days
|
0.00%
0/94 • 365 days
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.1%
1/88 • Number of events 1 • 365 days
|
1.1%
1/94 • Number of events 1 • 365 days
|
|
Nervous system disorders
Syncope
|
1.1%
1/88 • Number of events 1 • 365 days
|
0.00%
0/94 • 365 days
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/88 • 365 days
|
1.1%
1/94 • Number of events 1 • 365 days
|
Other adverse events
| Measure |
Oral TU
n=88 participants at risk
Subjects treated with Oral TU with a measurement taken after approximately 365 days of treatment are used for safety laboratory values for comparisons to baseline. All subjects who received at least one dose of study drug were included in the reporting of treatment emergent adverse events.
|
Transdermal T-gel
n=94 participants at risk
Subjects treated with Transdermal T-gel with a measurement taken after approximately 365 days of treatment are used for safety laboratory values for comparisons to baseline. All subjects who received at least one dose of study drug were included in the reporting of treatment emergent adverse events.
|
|---|---|---|
|
Blood and lymphatic system disorders
Polycythemia
|
5.7%
5/88 • Number of events 5 • 365 days
|
5.3%
5/94 • Number of events 5 • 365 days
|
|
Infections and infestations
Bronchitis
|
4.5%
4/88 • Number of events 4 • 365 days
|
4.3%
4/94 • Number of events 4 • 365 days
|
|
Infections and infestations
Sinusitis
|
4.5%
4/88 • Number of events 4 • 365 days
|
0.00%
0/94 • 365 days
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/88 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Investigations
Hematocrit Increased
|
4.5%
4/88 • Number of events 4 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Investigations
PSA Increased
|
2.3%
2/88 • Number of events 2 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Investigations
Hypertriglyceridemia
|
1.1%
1/88 • Number of events 1 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
0.00%
0/88 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
2/88 • Number of events 2 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Invertebral disc protrusion
|
0.00%
0/88 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/88 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Psychiatric disorders
Depression
|
2.3%
2/88 • Number of events 2 • 365 days
|
0.00%
0/94 • 365 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.3%
2/88 • Number of events 2 • 365 days
|
0.00%
0/94 • 365 days
|
|
Reproductive system and breast disorders
Prostatomegaly
|
1.1%
1/88 • Number of events 1 • 365 days
|
3.2%
3/94 • Number of events 3 • 365 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
3/88 • Number of events 3 • 365 days
|
2.1%
2/94 • Number of events 2 • 365 days
|
|
Vascular disorders
Hypertension
|
2.3%
2/88 • Number of events 2 • 365 days
|
3.2%
3/94 • Number of events 3 • 365 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60