Trial Outcomes & Findings for Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men (NCT NCT01403116)
NCT ID: NCT01403116
Last Updated: 2018-08-14
Results Overview
The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
325 participants
Primary outcome timeframe
Following 90 days of treatment
Results posted on
2018-08-14
Participant Flow
Participant milestones
| Measure |
Oral Testosterone Undecanoate (TU)
Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
* 100 mg BID
* 150 mg BID
* 100 mg BID
* 100 mg and 150 mg BID
* 150 mg capsules BID
Safety Follow-up Phase:
Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses
Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
Topical Testosterone Gel
Treatment Period 1: 5 g of 1% transdermal T-gel applied QD
Treatment Period 2:
* 2.5 g of 1% transdermal T-gel applied QD
* 5 g of 1% transdermal T-gel applied QD
* 7.5 g of 1% transdermal T-gel applied QD
* 10 g of 1% transdermal T-gel applied QD
Safety Follow-up Phase:
Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses
topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
160
|
|
Overall Study
Randomized
|
162
|
163
|
|
Overall Study
Randomized in Error/ No Treatment Recvd
|
1
|
3
|
|
Overall Study
COMPLETED
|
129
|
133
|
|
Overall Study
NOT COMPLETED
|
32
|
27
|
Reasons for withdrawal
| Measure |
Oral Testosterone Undecanoate (TU)
Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
* 100 mg BID
* 150 mg BID
* 100 mg BID
* 100 mg and 150 mg BID
* 150 mg capsules BID
Safety Follow-up Phase:
Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses
Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
Topical Testosterone Gel
Treatment Period 1: 5 g of 1% transdermal T-gel applied QD
Treatment Period 2:
* 2.5 g of 1% transdermal T-gel applied QD
* 5 g of 1% transdermal T-gel applied QD
* 7.5 g of 1% transdermal T-gel applied QD
* 10 g of 1% transdermal T-gel applied QD
Safety Follow-up Phase:
Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses
topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
12
|
15
|
|
Overall Study
Non-compliance of study drug
|
3
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
undisclosed Hx of Prostate Ca
|
1
|
0
|
|
Overall Study
Hct >54%
|
2
|
0
|
|
Overall Study
unable to keep appointments
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Baseline characteristics by cohort
| Measure |
Oral Testosterone Undecanoate (TU)
n=161 Participants
Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
* 100 mg BID
* 150 mg BID
* 100 mg BID
* 100 mg and 150 mg BID
* 150 mg capsules BID
Safety Follow-up Phase:
Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses
Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
Topical Testosterone Gel
n=160 Participants
Treatment Period 1: 5 g of 1% transdermal T-gel applied QD
Treatment Period 2:
* 2.5 g of 1% transdermal T-gel applied QD
* 5 g of 1% transdermal T-gel applied QD
* 7.5 g of 1% transdermal T-gel applied QD
* 10 g of 1% transdermal T-gel applied QD
Safety Follow-up Phase:
Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses
topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
134 Participants
n=99 Participants
|
136 Participants
n=107 Participants
|
270 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 11.06 • n=99 Participants
|
54.7 years
STANDARD_DEVIATION 11.18 • n=107 Participants
|
54.9 years
STANDARD_DEVIATION 11.10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
321 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
141 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Following 90 days of treatmentPopulation: Intent to treat population
The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL
Outcome measures
| Measure |
Oral Testosterone Undecanoate (TU)
n=146 Participants
Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
* 100 mg BID
* 150 mg BID
* 100 mg BID
* 100 mg and 150 mg BID
* 150 mg capsules BID
Safety Follow-up Phase:
Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses
Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
Topical Testosterone Gel
n=149 Participants
Treatment Period 1: 5 g of 1% transdermal T-gel applied QD
Treatment Period 2:
* 2.5 g of 1% transdermal T-gel applied QD
* 5 g of 1% transdermal T-gel applied QD
* 7.5 g of 1% transdermal T-gel applied QD
* 10 g of 1% transdermal T-gel applied QD
Safety Follow-up Phase:
Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses
topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
|---|---|---|
|
Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL
|
83.6 percentage of partipants
Interval 76.5 to 89.2
|
79.2 percentage of partipants
Interval 71.8 to 85.4
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Percent of oral TU treated subjects with Cmax \>1500 ng/dL at Study Day 90
Percentage of Oral TU treated patients who reached study day 90 and had a maximum serum T concentrations (Cmax) values greater than 1500 ng/dL(objective to meet \<15%).
Outcome measures
| Measure |
Oral Testosterone Undecanoate (TU)
n=149 Participants
Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
* 100 mg BID
* 150 mg BID
* 100 mg BID
* 100 mg and 150 mg BID
* 150 mg capsules BID
Safety Follow-up Phase:
Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses
Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
Topical Testosterone Gel
Treatment Period 1: 5 g of 1% transdermal T-gel applied QD
Treatment Period 2:
* 2.5 g of 1% transdermal T-gel applied QD
* 5 g of 1% transdermal T-gel applied QD
* 7.5 g of 1% transdermal T-gel applied QD
* 10 g of 1% transdermal T-gel applied QD
Safety Follow-up Phase:
Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses
topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
|---|---|---|
|
% of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90
|
61 Participants
|
—
|
Adverse Events
Oral Testosterone Undecanoate (TU)
Serious events: 11 serious events
Other events: 110 other events
Deaths: 0 deaths
Topical Testosterone Gel
Serious events: 6 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Testosterone Undecanoate (TU)
n=161 participants at risk
Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
* 100 mg BID
* 150 mg BID
* 100 mg BID
* 100 mg and 150 mg BID
* 150 mg capsules BID
Safety Follow-up Phase:
Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses
Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
Topical Testosterone Gel
n=160 participants at risk
Treatment Period 1: 5 g of 1% transdermal T-gel applied QD
Treatment Period 2:
* 2.5 g of 1% transdermal T-gel applied QD
* 5 g of 1% transdermal T-gel applied QD
* 7.5 g of 1% transdermal T-gel applied QD
* 10 g of 1% transdermal T-gel applied QD
Safety Follow-up Phase:
Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses
topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
2/161
|
0.00%
0/160
|
|
Cardiac disorders
Angina pectoris
|
0.62%
1/161
|
0.00%
0/160
|
|
Cardiac disorders
Coronary Artery Disease
|
1.2%
2/161
|
0.62%
1/160
|
|
Infections and infestations
Appendicitis
|
0.00%
0/161
|
1.2%
2/160
|
|
Infections and infestations
Gastroenteritis
|
0.62%
1/161
|
0.00%
0/160
|
|
Infections and infestations
Peritonitis
|
0.00%
0/161
|
0.62%
1/160
|
|
Infections and infestations
Pneumonia
|
0.62%
1/161
|
0.00%
0/160
|
|
Infections and infestations
Sinusitis
|
0.62%
1/161
|
0.00%
0/160
|
|
Infections and infestations
Urosepsis
|
0.62%
1/161
|
0.00%
0/160
|
|
Injury, poisoning and procedural complications
Brachial plexus injury
|
0.00%
0/161
|
0.62%
1/160
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/161
|
0.62%
1/160
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.62%
1/161
|
0.00%
0/160
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
1/161
|
0.00%
0/160
|
|
Musculoskeletal and connective tissue disorders
Inverterbral disc degeneration
|
1.9%
3/161
|
0.62%
1/160
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.62%
1/161
|
0.00%
0/160
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.62%
1/161
|
0.00%
0/160
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
1/161
|
0.00%
0/160
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolosis
|
0.00%
0/161
|
0.62%
1/160
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.62%
1/161
|
0.00%
0/160
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.62%
1/161
|
0.00%
0/160
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/161
|
0.62%
1/160
|
|
Nervous system disorders
Epilepsy
|
0.62%
1/161
|
0.00%
0/160
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.62%
1/161
|
0.00%
0/160
|
|
Nervous system disorders
Nervous system disorder
|
0.62%
1/161
|
0.00%
0/160
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/161
|
0.62%
1/160
|
Other adverse events
| Measure |
Oral Testosterone Undecanoate (TU)
n=161 participants at risk
Treatment Period 1: 100 mg capsules, BID, with food
Treatment Period 2: One of the following dosages:
* 100 mg BID
* 150 mg BID
* 100 mg BID
* 100 mg and 150 mg BID
* 150 mg capsules BID
Safety Follow-up Phase:
Initial dose: \~84 doses Maintenance dose-Titrated dose: \~96 doses Safety follow-up at maintenance dose: \~540 doses
Oral testosterone undecanoate: Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
Topical Testosterone Gel
n=160 participants at risk
Treatment Period 1: 5 g of 1% transdermal T-gel applied QD
Treatment Period 2:
* 2.5 g of 1% transdermal T-gel applied QD
* 5 g of 1% transdermal T-gel applied QD
* 7.5 g of 1% transdermal T-gel applied QD
* 10 g of 1% transdermal T-gel applied QD
Safety Follow-up Phase:
Initial dose: \~42 doses Maintenance dose-Titrated dose: \~48 doses Safety follow-up at maintenance dose: \~270 doses
topical testosterone gel: Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
|
|---|---|---|
|
Blood and lymphatic system disorders
Polycythaemia
|
8.1%
13/161
|
3.8%
6/160
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.1%
5/161
|
0.00%
0/160
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
9/161
|
1.9%
3/160
|
|
Gastrointestinal disorders
Eructation
|
2.5%
4/161
|
0.00%
0/160
|
|
Gastrointestinal disorders
Nausea
|
2.5%
4/161
|
2.5%
4/160
|
|
General disorders
Oedema peripheral
|
5.6%
9/161
|
1.2%
2/160
|
|
Infections and infestations
Gastroenteritis viral
|
2.5%
4/161
|
1.2%
2/160
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
10/161
|
4.4%
7/160
|
|
Infections and infestations
Sinusitis
|
3.1%
5/161
|
3.1%
5/160
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
11/161
|
2.5%
4/160
|
|
Investigations
Prostatic specific antigen
|
3.1%
5/161
|
5.0%
8/160
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
2.5%
4/161
|
3.8%
6/160
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
4/161
|
1.2%
2/160
|
|
Nervous system disorders
Dizziness
|
2.5%
4/161
|
1.2%
2/160
|
|
Nervous system disorders
Headache
|
2.5%
4/161
|
3.1%
5/160
|
|
Reproductive system and breast disorders
Prostatitis
|
2.5%
4/161
|
1.2%
2/160
|
|
Reproductive system and breast disorders
Prostatomegaly
|
5.6%
9/161
|
3.1%
5/160
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
3/161
|
2.5%
4/160
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.62%
1/161
|
2.5%
4/160
|
|
Vascular disorders
Hypertension
|
3.7%
6/161
|
6.9%
11/160
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60