Trial Outcomes & Findings for The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) (NCT NCT01386606)
NCT ID: NCT01386606
Last Updated: 2015-09-23
Results Overview
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2015-09-23
Participant Flow
Participant milestones
| Measure |
Androxal 6.25 mg
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
16
|
14
|
|
Overall Study
COMPLETED
|
12
|
10
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
1
|
Reasons for withdrawal
| Measure |
Androxal 6.25 mg
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Overall Study
Subject incarcerated
|
0
|
1
|
0
|
0
|
|
Overall Study
Unable to draw PK
|
1
|
0
|
0
|
0
|
|
Overall Study
T levels too high
|
0
|
1
|
1
|
0
|
Baseline Characteristics
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
Baseline characteristics by cohort
| Measure |
Androxal 6.25 mg
n=16 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
n=14 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
n=16 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
n=14 Participants
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
51.7 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
51.8 years
STANDARD_DEVIATION 13.0 • n=206 Participants
|
53.5 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 10.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
16 participants
n=206 Participants
|
14 participants
n=7 Participants
|
60 participants
n=31 Participants
|
|
BMI
|
33.3 Kg/m^2
STANDARD_DEVIATION 5.9 • n=99 Participants
|
31.2 Kg/m^2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
31.6 Kg/m^2
STANDARD_DEVIATION 6.3 • n=206 Participants
|
31.0 Kg/m^2
STANDARD_DEVIATION 6.1 • n=7 Participants
|
31.8 Kg/m^2
STANDARD_DEVIATION 6.1 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
Outcome measures
| Measure |
Androxal 6.25 mg
n=12 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
n=10 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
n=13 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
n=13 Participants
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
24 Hour Average and Maximum Testosterone Concentration
TTavg at Baseline
|
262.3 ng/dL
Standard Deviation 80.3
|
373.6 ng/dL
Standard Deviation 172.1
|
298.3 ng/dL
Standard Deviation 100.5
|
322.4 ng/dL
Standard Deviation 102.9
|
|
24 Hour Average and Maximum Testosterone Concentration
TTavg at Week 6
|
392.4 ng/dL
Standard Deviation 152.6
|
460.8 ng/dL
Standard Deviation 129.1
|
586.7 ng/dL
Standard Deviation 142.4
|
543.9 ng/dL
Standard Deviation 229.8
|
|
24 Hour Average and Maximum Testosterone Concentration
TTmax at Baseline
|
358.5 ng/dL
Standard Deviation 120.5
|
513.7 ng/dL
Standard Deviation 222.2
|
425.9 ng/dL
Standard Deviation 114.3
|
562.3 ng/dL
Standard Deviation 488.5
|
|
24 Hour Average and Maximum Testosterone Concentration
TTmax at Week 6
|
524.5 ng/dL
Standard Deviation 178.7
|
607.5 ng/dL
Standard Deviation 167.7
|
764.3 ng/dL
Standard Deviation 158.7
|
930.1 ng/dL
Standard Deviation 550.4
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6Population: ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
Changes in morning LH after continuous dosing
Outcome measures
| Measure |
Androxal 6.25 mg
n=15 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
n=13 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
n=16 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
n=14 Participants
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Change in Leuteinizing Hormone (LH)
Morning LH at Baseline
|
3.63 mIU/mL
Standard Deviation 1.55
|
4.82 mIU/mL
Standard Deviation 1.63
|
4.98 mIU/mL
Standard Deviation 3.45
|
3.57 mIU/mL
Standard Deviation 2.23
|
|
Change in Leuteinizing Hormone (LH)
Morning LH at Week 2
|
5.49 mIU/mL
Standard Deviation 2.69
|
8.60 mIU/mL
Standard Deviation 4.11
|
9.64 mIU/mL
Standard Deviation 5.04
|
2.00 mIU/mL
Standard Deviation 2.12
|
|
Change in Leuteinizing Hormone (LH)
Morning LH Change from Baseline at Week 2
|
1.99 mIU/mL
Standard Deviation 2.38
|
3.78 mIU/mL
Standard Deviation 3.29
|
4.66 mIU/mL
Standard Deviation 3.56
|
-1.57 mIU/mL
Standard Deviation 2.20
|
|
Change in Leuteinizing Hormone (LH)
Morning LH at Week 4
|
6.92 mIU/mL
Standard Deviation 3.59
|
7.20 mIU/mL
Standard Deviation 2.97
|
11.78 mIU/mL
Standard Deviation 7.39
|
1.88 mIU/mL
Standard Deviation 2.68
|
|
Change in Leuteinizing Hormone (LH)
Morning LH Change from Baseline at Week 4
|
3.43 mIU/mL
Standard Deviation 3.20
|
2.38 mIU/mL
Standard Deviation 3.54
|
6.79 mIU/mL
Standard Deviation 5.54
|
-1.69 mIU/mL
Standard Deviation 1.58
|
|
Change in Leuteinizing Hormone (LH)
Morning LH at Week 6
|
6.1 mIU/mL
Standard Deviation 3.3
|
8.2 mIU/mL
Standard Deviation 3.3
|
14.5 mIU/mL
Standard Deviation 10.5
|
2.2 mIU/mL
Standard Deviation 2.8
|
|
Change in Leuteinizing Hormone (LH)
Morning LH Change from Baseline at Week 6
|
2.60 mIU/mL
Standard Deviation 3.32
|
3.39 mIU/mL
Standard Deviation 3.37
|
9.51 mIU/mL
Standard Deviation 8.15
|
-1.41 mIU/mL
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6Population: ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
Changes in morning FSH after continuous dosing
Outcome measures
| Measure |
Androxal 6.25 mg
n=15 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
n=13 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
n=16 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
n=14 Participants
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Change in Follicle Stimulating Hormone (FSH)
Morning FSH at Week 4
|
6.45 mIU/mL
Standard Deviation 2.70
|
7.12 mIU/mL
Standard Deviation 2.66
|
12.34 mIU/mL
Standard Deviation 9.59
|
3.72 mIU/mL
Standard Deviation 3.66
|
|
Change in Follicle Stimulating Hormone (FSH)
Morning FSH at Baseline
|
4.61 mIU/mL
Standard Deviation 1.97
|
5.63 mIU/mL
Standard Deviation 2.26
|
6.31 mIU/mL
Standard Deviation 4.28
|
6.38 mIU/mL
Standard Deviation 2.79
|
|
Change in Follicle Stimulating Hormone (FSH)
Morning FSH at Week 2
|
6.18 mIU/mL
Standard Deviation 2.56
|
7.77 mIU/mL
Standard Deviation 3.03
|
11.41 mIU/mL
Standard Deviation 8.19
|
3.80 mIU/mL
Standard Deviation 3.06
|
|
Change in Follicle Stimulating Hormone (FSH)
Morning FSH Change from Baseline at Week 2
|
1.60 mIU/mL
Standard Deviation 1.73
|
2.14 mIU/mL
Standard Deviation 2.15
|
5.09 mIU/mL
Standard Deviation 4.32
|
-2.58 mIU/mL
Standard Deviation 1.84
|
|
Change in Follicle Stimulating Hormone (FSH)
Morning FSH Change from Baseline at Week 4
|
1.66 mIU/mL
Standard Deviation 1.94
|
1.48 mIU/mL
Standard Deviation 2.58
|
6.03 mIU/mL
Standard Deviation 5.90
|
-2.66 mIU/mL
Standard Deviation 2.20
|
|
Change in Follicle Stimulating Hormone (FSH)
Morning FSH at Week 6
|
5.69 mIU/mL
Standard Deviation 3.34
|
8.19 mIU/mL
Standard Deviation 3.25
|
13.45 mIU/mL
Standard Deviation 10.84
|
3.35 mIU/mL
Standard Deviation 3.34
|
|
Change in Follicle Stimulating Hormone (FSH)
Morning FSH Change from Baseline at Week 6
|
1.42 mIU/mL
Standard Deviation 2.53
|
2.56 mIU/mL
Standard Deviation 2.53
|
7.14 mIU/mL
Standard Deviation 7.19
|
-3.03 mIU/mL
Standard Deviation 2.21
|
POST_HOC outcome
Timeframe: Week 6Population: All Androxal subjects with Week 6 serial testosterone measurements.
9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax. If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation.
Outcome measures
| Measure |
Androxal 6.25 mg
n=35 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Morning Testosterone Correlated With Serial Testosterone.
|
35 Number of Subjects
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: PK population
The Cmax for plasma concentration.
Outcome measures
| Measure |
Androxal 6.25 mg
n=12 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
n=10 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
n=13 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
|
1.8154 ng/mL
Standard Deviation 0.8358
|
3.3899 ng/mL
Standard Deviation 2.0239
|
16.2993 ng/mL
Standard Deviation 12.8952
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: PK population
The Tmax for plasma concentration.
Outcome measures
| Measure |
Androxal 6.25 mg
n=12 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
n=10 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
n=13 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
|
2.33 h
Standard Deviation 0.98
|
2.42 h
Standard Deviation 1.21
|
2.41 h
Standard Deviation 1.48
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6Population: PK population
The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).
Outcome measures
| Measure |
Androxal 6.25 mg
n=12 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
n=10 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
n=13 Participants
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
|
21.200 ng*h/mL
Standard Deviation 14.399
|
34.012 ng*h/mL
Standard Deviation 21.419
|
150.51 ng*h/mL
Standard Deviation 132.32
|
—
|
Adverse Events
Androxal 6.25 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Androxal 12.5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Androxal 25 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AndroGel
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Androxal 6.25 mg
n=16 participants at risk
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 12.5 mg
n=14 participants at risk
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
Androxal 25 mg
n=16 participants at risk
enclomiphene citrate: capsule oral
1X a day 6 weeks
|
AndroGel
n=14 participants at risk
AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks
|
|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
|
7.1%
1/14
|
6.2%
1/16
|
0.00%
0/14
|
|
General disorders
Irritability
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
7.1%
1/14
|
|
Nervous system disorders
Allodynia
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
7.1%
1/14
|
|
Psychiatric disorders
Aggression
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/16
|
0.00%
0/14
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
0.00%
0/14
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
7.1%
1/14
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/16
|
0.00%
0/14
|
|
Reproductive system and breast disorders
Epididymal cyst
|
6.2%
1/16
|
0.00%
0/14
|
0.00%
0/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/16
|
7.1%
1/14
|
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