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Trial record 47 of 213 for:    "Hypogonadism" | "Androgens"

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

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ClinicalTrials.gov Identifier: NCT01270841
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Secondary Hypogonadism
Interventions Drug: Placebo
Drug: topical testosterone
Drug: Androxal
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Period Title: Overall Study
Started 29 33 29 33
Completed 16 19 18 20
Not Completed 13 14 11 13
Reason Not Completed
Adverse Event             0             1             0             3
Withdrawal by Subject             3             2             3             3
Lost to Follow-up             3             1             4             2
Physician Decision             0             1             0             0
Did not qualify             6             3             4             5
Protocol Violation             1             5             0             0
Enrolled in error             0             1             0             0
Arm/Group Title Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg Total
Hide Arm/Group Description

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Total of all reporting groups
Overall Number of Baseline Participants 28 33 27 33 121
Hide Baseline Analysis Population Description
Safety population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 33 participants 27 participants 33 participants 121 participants
51.6  (11.7) 52.0  (10.6) 49.7  (11.6) 49.2  (10.9) 50.6  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 33 participants 27 participants 33 participants 121 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
28
 100.0%
33
 100.0%
27
 100.0%
33
 100.0%
121
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 33 participants 27 participants 33 participants 121 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   3.7%
1
   3.0%
2
   1.7%
Asian
4
  14.3%
6
  18.2%
2
   7.4%
6
  18.2%
18
  14.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   3.7%
0
   0.0%
1
   0.8%
Black or African American
7
  25.0%
4
  12.1%
5
  18.5%
6
  18.2%
22
  18.2%
White
17
  60.7%
23
  69.7%
18
  66.7%
20
  60.6%
78
  64.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 33 participants 27 participants 33 participants 121 participants
28 33 27 33 121
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 28 participants 33 participants 27 participants 33 participants 121 participants
30.9  (4.2) 33.1  (5.9) 32.6  (5.2) 31.7  (4.9) 32.1  (5.1)
1.Primary Outcome
Title Change in Total Morning Testosterone
Hide Description Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat subjects with an assessment after baseline
Arm/Group Title Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Overall Number of Participants Analyzed 26 30 25 32
Mean (Standard Deviation)
Unit of Measure: ng/dL
-16.9  (47.5) 253.7  (292.3) 258.5  (201.5) 197.3  (162.6)
2.Secondary Outcome
Title Change in Luteinizing Hormone Levels
Hide Description Changes in values from baseline in LH at month 3
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Overall Number of Participants Analyzed 26 30 25 32
Mean (Standard Deviation)
Unit of Measure: mIU/mL
-0.1  (1.0) -2.4  (2.4) 4.8  (4.7) 6.9  (7.7)
3.Secondary Outcome
Title Change in FSH After 3 Months of Treatment
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Overall Number of Participants Analyzed 26 30 25 32
Mean (Standard Deviation)
Unit of Measure: mIU/mL
-0.2  (0.7) -4.4  (2.9) 5.1  (6.2) 7.4  (6.5)
4.Secondary Outcome
Title Reproductive Safety
Hide Description Change from baseline in sperm concentration
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with end of study assessments
Arm/Group Title Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Overall Number of Participants Analyzed 13 13 12 19
Mean (Standard Deviation)
Unit of Measure: millions/mL
-19.1  (93.4) -29.5  (39.0) 8.2  (233.1) -2.8  (167.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

All-Cause Mortality
Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      1/33 (3.03%)      0/27 (0.00%)      0/33 (0.00%)    
Metabolism and nutrition disorders         
Hyperglycemia  1 [1]  0/28 (0.00%)  0 1/33 (3.03%)  1 0/27 (0.00%)  0 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Subject was admitted to the hospital for high A1C level of 16.9. The PI assessed the event as moderate in intensity, and definitely not related to the study medication.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Testim (Topical Testosterone) Androxal 12.5 mg Androxal 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/28 (10.71%)      15/33 (45.45%)      3/27 (11.11%)      3/33 (9.09%)    
Gastrointestinal disorders         
Nausea  1  0/28 (0.00%)  1/33 (3.03%)  1/27 (3.70%)  2/33 (6.06%) 
Diarrhea  1  1/28 (3.57%)  1/33 (3.03%)  2/27 (7.41%)  1/33 (3.03%) 
Addominal Pain Upper  1  2/28 (7.14%)  1/33 (3.03%)  0/27 (0.00%)  0/33 (0.00%) 
Infections and infestations         
Sinusitis  1  0/28 (0.00%)  2/33 (6.06%)  0/27 (0.00%)  0/33 (0.00%) 
Investigations         
Sperm concentration decreased  1  0/28 (0.00%)  8/33 (24.24%)  0/27 (0.00%)  0/33 (0.00%)  0
Skin and subcutaneous tissue disorders         
Acne  1  0/28 (0.00%)  2/33 (6.06%)  0/27 (0.00%)  0/33 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer L. Wike
Organization: Repros Therapeutics Inc.
Phone: 281-719-3402
EMail: jwike@reprosrx.com
Layout table for additonal information
Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01270841     History of Changes
Other Study ID Numbers: ZA-203
First Submitted: January 4, 2011
First Posted: January 5, 2011
Results First Submitted: June 18, 2014
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014