Trial Outcomes & Findings for Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism (NCT NCT01270841)
NCT ID: NCT01270841
Last Updated: 2014-07-28
Results Overview
Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
3 months
Results posted on
2014-07-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
33
|
29
|
33
|
|
Overall Study
COMPLETED
|
16
|
19
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
11
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
4
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Did not qualify
|
6
|
3
|
4
|
5
|
|
Overall Study
Protocol Violation
|
1
|
5
|
0
|
0
|
|
Overall Study
Enrolled in error
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
n=33 Participants
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
n=27 Participants
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
n=33 Participants
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 11.7 • n=39 Participants
|
52.0 years
STANDARD_DEVIATION 10.6 • n=41 Participants
|
49.7 years
STANDARD_DEVIATION 11.6 • n=35 Participants
|
49.2 years
STANDARD_DEVIATION 10.9 • n=31 Participants
|
50.6 years
STANDARD_DEVIATION 11.2 • n=146 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
33 Participants
n=31 Participants
|
121 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
18 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
22 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
78 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=39 Participants
|
33 participants
n=41 Participants
|
27 participants
n=35 Participants
|
33 participants
n=31 Participants
|
121 participants
n=146 Participants
|
|
BMI
|
30.9 kg/m2
STANDARD_DEVIATION 4.2 • n=39 Participants
|
33.1 kg/m2
STANDARD_DEVIATION 5.9 • n=41 Participants
|
32.6 kg/m2
STANDARD_DEVIATION 5.2 • n=35 Participants
|
31.7 kg/m2
STANDARD_DEVIATION 4.9 • n=31 Participants
|
32.1 kg/m2
STANDARD_DEVIATION 5.1 • n=146 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intent to treat subjects with an assessment after baseline
Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
n=30 Participants
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
n=25 Participants
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
n=32 Participants
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
|---|---|---|---|---|
|
Change in Total Morning Testosterone
|
-16.9 ng/dL
Standard Deviation 47.5
|
253.7 ng/dL
Standard Deviation 292.3
|
258.5 ng/dL
Standard Deviation 201.5
|
197.3 ng/dL
Standard Deviation 162.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT population
Changes in values from baseline in LH at month 3
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
n=30 Participants
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
n=25 Participants
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
n=32 Participants
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
|---|---|---|---|---|
|
Change in Luteinizing Hormone Levels
|
-0.1 mIU/mL
Standard Deviation 1.0
|
-2.4 mIU/mL
Standard Deviation 2.4
|
4.8 mIU/mL
Standard Deviation 4.7
|
6.9 mIU/mL
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT population
Outcome measures
| Measure |
Placebo
n=26 Participants
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
n=30 Participants
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
n=25 Participants
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
n=32 Participants
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
|---|---|---|---|---|
|
Change in FSH After 3 Months of Treatment
|
-0.2 mIU/mL
Standard Deviation 0.7
|
-4.4 mIU/mL
Standard Deviation 2.9
|
5.1 mIU/mL
Standard Deviation 6.2
|
7.4 mIU/mL
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Subjects with end of study assessments
Change from baseline in sperm concentration
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
n=13 Participants
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
n=12 Participants
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
n=19 Participants
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
|---|---|---|---|---|
|
Reproductive Safety
|
-19.1 millions/mL
Standard Deviation 93.4
|
-29.5 millions/mL
Standard Deviation 39.0
|
8.2 millions/mL
Standard Deviation 233.1
|
-2.8 millions/mL
Standard Deviation 167.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Testim (Topical Testosterone)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Androxal 12.5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Androxal 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
n=33 participants at risk
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
n=27 participants at risk
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
n=33 participants at risk
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/28
|
3.0%
1/33 • Number of events 1
|
0.00%
0/27
|
0.00%
0/33
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Testim (Topical Testosterone)
n=33 participants at risk
Testim (topical testosterone)
topical testosterone: testosterone gel applied 1x daily for 3 months
|
Androxal 12.5 mg
n=27 participants at risk
Androxal 12.5 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
Androxal 25 mg
n=33 participants at risk
Androxal 25 mg/day
Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28
|
3.0%
1/33
|
3.7%
1/27
|
6.1%
2/33
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28
|
3.0%
1/33
|
7.4%
2/27
|
3.0%
1/33
|
|
Gastrointestinal disorders
Addominal Pain Upper
|
7.1%
2/28
|
3.0%
1/33
|
0.00%
0/27
|
0.00%
0/33
|
|
Infections and infestations
Sinusitis
|
0.00%
0/28
|
6.1%
2/33
|
0.00%
0/27
|
0.00%
0/33
|
|
Investigations
Sperm concentration decreased
|
0.00%
0/28
|
24.2%
8/33
|
0.00%
0/27
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/28
|
6.1%
2/33
|
0.00%
0/27
|
0.00%
0/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER