Trial Outcomes & Findings for Safety and Efficacy Trial of Testosterone Undecanoate (NCT NCT01765179)
NCT ID: NCT01765179
Last Updated: 2017-12-12
Results Overview
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Results posted on
2017-12-12
Participant Flow
Participant milestones
| Measure |
Oral Testosterone Undecanoate
Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
|
|---|---|
|
Overall Study
STARTED
|
144
|
|
Overall Study
COMPLETED
|
117
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Oral Testosterone Undecanoate
Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Non-compliance with study drug
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Hematocrit >54%
|
3
|
|
Overall Study
prohibited med
|
1
|
|
Overall Study
Out of country unable to finish study
|
1
|
|
Overall Study
lack of venous access
|
1
|
|
Overall Study
work conflict
|
1
|
|
Overall Study
Ca elevated 10.6
|
1
|
Baseline Characteristics
Safety and Efficacy Trial of Testosterone Undecanoate
Baseline characteristics by cohort
| Measure |
Oral Testosterone Undecanoate
n=144 Participants
Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
116 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=99 Participants
|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 10.60 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
15 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
114 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
144 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114Population: The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
Outcome measures
| Measure |
Oral Testosterone Undecanoate
n=116 Participants
Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
|
|---|---|
|
Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
|
87 Participants
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114Population: The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
Outcome measures
| Measure |
Oral Testosterone Undecanoate
n=116 Participants
Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
|
|---|---|
|
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
Cmax less that 1500 ng/dL
|
95 Participants
|
|
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
Cmax between 1500 and 1800 ng/dL
|
10 Participants
|
|
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
Cmax >1800 to 2500 ng/dL
|
7 Participants
|
|
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
Cmax >2500 ng/dL
|
4 Participants
|
Adverse Events
Oral Testosterone Undecanoate
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Testosterone Undecanoate
n=144 participants at risk
Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
|
|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.69%
1/144 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.69%
1/144 • Number of events 1
|
Other adverse events
| Measure |
Oral Testosterone Undecanoate
n=144 participants at risk
Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
|
|---|---|
|
Gastrointestinal disorders
diarrhea
|
3.5%
5/144
|
|
Gastrointestinal disorders
dyspepsia
|
2.8%
4/144
|
|
Gastrointestinal disorders
eructation
|
2.1%
3/144
|
|
Gastrointestinal disorders
haemorrhoids
|
2.1%
3/144
|
|
General disorders
oedema peripheral
|
2.8%
4/144
|
|
Infections and infestations
nasopharyngitis
|
2.1%
3/144
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection
|
3.5%
5/144
|
|
Investigations
blood creatinine increased
|
2.1%
3/144
|
|
Investigations
blood glucose increased
|
2.1%
3/144
|
|
Investigations
haematocrit
|
2.1%
3/144
|
|
Metabolism and nutrition disorders
gout
|
2.1%
3/144
|
|
Reproductive system and breast disorders
prostatomegaly
|
2.1%
3/144
|
|
Vascular disorders
hypertension
|
2.8%
4/144
|
Additional Information
Sr. VP Clinical and Medical Affairs
Clarus Therapeutics
Phone: 847-562-4300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60