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Trial record 27 of 51 for:    "Hypogonadism" | "Estrogens"

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01386606
Recruitment Status : Completed
First Posted : July 1, 2011
Results First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Secondary Hypogonadism
Interventions Drug: Androxal (enclomiphene citrate)
Drug: Testosterone
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel
Hide Arm/Group Description

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks

Period Title: Overall Study
Started 16 14 16 14
Completed 12 10 13 13
Not Completed 4 4 3 1
Reason Not Completed
Adverse Event             0             1             0             0
Withdrawal by Subject             0             1             1             0
Protocol Violation             1             0             1             1
Lost to Follow-up             2             0             0             0
Subject incarcerated             0             1             0             0
Unable to draw PK             1             0             0             0
T levels too high             0             1             1             0
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel Total
Hide Arm/Group Description

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks

Total of all reporting groups
Overall Number of Baseline Participants 16 14 16 14 60
Hide Baseline Analysis Population Description
The baseline analysis consisted of all subjects enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 16 participants 14 participants 60 participants
53.4  (8.8) 51.7  (9.2) 51.8  (13.0) 53.5  (9.8) 52.6  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 16 participants 14 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
16
 100.0%
14
 100.0%
16
 100.0%
14
 100.0%
60
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 16 participants 14 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  50.0%
8
  57.1%
10
  62.5%
2
  14.3%
28
  46.7%
White
8
  50.0%
6
  42.9%
6
  37.5%
12
  85.7%
32
  53.3%
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 16 participants 14 participants 16 participants 14 participants 60 participants
16 14 16 14 60
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 16 participants 14 participants 16 participants 14 participants 60 participants
33.3  (5.9) 31.2  (6.6) 31.6  (6.3) 31.0  (6.1) 31.8  (6.1)
1.Primary Outcome
Title 24 Hour Average and Maximum Testosterone Concentration
Hide Description

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.

Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel
Hide Arm/Group Description:

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks

Overall Number of Participants Analyzed 12 10 13 13
Mean (Standard Deviation)
Unit of Measure: ng/dL
TTavg at Baseline 262.3  (80.3) 373.6  (172.1) 298.3  (100.5) 322.4  (102.9)
TTavg at Week 6 392.4  (152.6) 460.8  (129.1) 586.7  (142.4) 543.9  (229.8)
TTmax at Baseline 358.5  (120.5) 513.7  (222.2) 425.9  (114.3) 562.3  (488.5)
TTmax at Week 6 524.5  (178.7) 607.5  (167.7) 764.3  (158.7) 930.1  (550.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments

Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.

Modeling 24 hour average total testosterone by morning testosterone and treatment group.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments P-value of treatment group.
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments

Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.

Modeling 24 hour average total testosterone by morning testosterone and treatment group.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.436
Comments P-value for Androxal 25 mg treatment group.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression Coefficient
Estimated Value -45.77
Confidence Interval (2-Sided) 95%
-143.5 to 51.98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments

Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.

Modeling 24 hour average total testosterone by morning testosterone and treatment group.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments P-value for Androxal 12.5 mg group.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression Coefficient
Estimated Value -110.9
Confidence Interval (2-Sided) 95%
-210.6 to -11.23
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments

Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.

Modeling 24 hour average total testosterone by morning testosterone and treatment group.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value for Androxal 6.25 mg group.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression Coefficient
Estimated Value -148.5
Confidence Interval (2-Sided) 95%
-242.9 to -54.05
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments

Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.

Modeling 24 hour average total testosterone by morning testosterone and treatment group.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for morning total testosterone (adjusted for treatment effect if treatment group is significant).
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Regression Coefficient
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.37 to 0.79
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Leuteinizing Hormone (LH)
Hide Description Changes in morning LH after continuous dosing
Time Frame Baseline, Week 2, Week 4, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel
Hide Arm/Group Description:

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks

Overall Number of Participants Analyzed 15 13 16 14
Mean (Standard Deviation)
Unit of Measure: mIU/mL
Morning LH at Baseline 3.63  (1.55) 4.82  (1.63) 4.98  (3.45) 3.57  (2.23)
Morning LH at Week 2 5.49  (2.69) 8.60  (4.11) 9.64  (5.04) 2.00  (2.12)
Morning LH Change from Baseline at Week 2 1.99  (2.38) 3.78  (3.29) 4.66  (3.56) -1.57  (2.20)
Morning LH at Week 4 6.92  (3.59) 7.20  (2.97) 11.78  (7.39) 1.88  (2.68)
Morning LH Change from Baseline at Week 4 3.43  (3.20) 2.38  (3.54) 6.79  (5.54) -1.69  (1.58)
Morning LH at Week 6 6.1  (3.3) 8.2  (3.3) 14.5  (10.5) 2.2  (2.8)
Morning LH Change from Baseline at Week 6 2.60  (3.32) 3.39  (3.37) 9.51  (8.15) -1.41  (2.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for treatment group effect.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for treatment group effect.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for treatment group effect.
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Follicle Stimulating Hormone (FSH)
Hide Description Changes in morning FSH after continuous dosing
Time Frame Baseline, Week 2, Week 4, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel
Hide Arm/Group Description:

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks

Overall Number of Participants Analyzed 15 13 16 14
Mean (Standard Deviation)
Unit of Measure: mIU/mL
Morning FSH at Baseline 4.61  (1.97) 5.63  (2.26) 6.31  (4.28) 6.38  (2.79)
Morning FSH at Week 2 6.18  (2.56) 7.77  (3.03) 11.41  (8.19) 3.80  (3.06)
Morning FSH Change from Baseline at Week 2 1.60  (1.73) 2.14  (2.15) 5.09  (4.32) -2.58  (1.84)
Morning FSH at Week 4 6.45  (2.70) 7.12  (2.66) 12.34  (9.59) 3.72  (3.66)
Morning FSH Change from Baseline at Week 4 1.66  (1.94) 1.48  (2.58) 6.03  (5.90) -2.66  (2.20)
Morning FSH at Week 6 5.69  (3.34) 8.19  (3.25) 13.45  (10.84) 3.35  (3.34)
Morning FSH Change from Baseline at Week 6 1.42  (2.53) 2.56  (2.53) 7.14  (7.19) -3.03  (2.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for treatment group effect.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for treatment group effect.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Androxal 6.25 mg, Androxal 12.5 mg, Androxal 25 mg, AndroGel
Comments ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for treatment group effect.
Method ANOVA
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
Hide Description The Cmax for plasma concentration.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 6.25 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Androxal 12.5 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Androxal 25 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Overall Number of Participants Analyzed 12 10 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.8154  (0.8358) 3.3899  (2.0239) 16.2993  (12.8952)
5.Other Pre-specified Outcome
Title Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
Hide Description The Tmax for plasma concentration.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 6.25 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Androxal 12.5 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Androxal 25 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Overall Number of Participants Analyzed 12 10 13
Mean (Standard Deviation)
Unit of Measure: h
2.33  (0.98) 2.42  (1.21) 2.41  (1.48)
6.Other Pre-specified Outcome
Title Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
Hide Description The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 6.25 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Androxal 12.5 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Androxal 25 mg/day

Androxal (enclomiphene citrate): capsule oral

1X a day 6 weeks

Overall Number of Participants Analyzed 12 10 13
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
21.200  (14.399) 34.012  (21.419) 150.51  (132.32)
7.Post-Hoc Outcome
Title Morning Testosterone Correlated With Serial Testosterone.
Hide Description

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.

Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All Androxal subjects with Week 6 serial testosterone measurements.
Arm/Group Title Androxal Pooled Dose Levels
Hide Arm/Group Description:
Androxal 6.25, 12.5, and 25 mg subjects combined into a single group.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Number of Subjects
35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androxal Pooled Dose Levels
Comments Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation
Estimated Value 0.90993
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Androxal Pooled Dose Levels
Comments Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation
Estimated Value 0.86541
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Androxal Pooled Dose Levels
Comments Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation
Estimated Value 0.89643
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel
Hide Arm/Group Description

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

enclomiphene citrate: capsule oral

1X a day 6 weeks

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks

All-Cause Mortality
Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%)   0/16 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Androxal 6.25 mg Androxal 12.5 mg Androxal 25 mg AndroGel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/16 (12.50%)   1/14 (7.14%)   1/16 (6.25%)   4/14 (28.57%) 
Eye disorders         
Vision blurred   0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders         
Defaecation urgency   0/16 (0.00%)  1/14 (7.14%)  0/16 (0.00%)  0/14 (0.00%) 
Diarrhoea   0/16 (0.00%)  1/14 (7.14%)  1/16 (6.25%)  0/14 (0.00%) 
General disorders         
Irritability   0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders         
Fluid retention   0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%)  1/14 (7.14%) 
Nervous system disorders         
Allodynia   0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%)  1/14 (7.14%) 
Psychiatric disorders         
Aggression   0/16 (0.00%)  1/14 (7.14%)  0/16 (0.00%)  0/14 (0.00%) 
Insomnia   1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%)  0/14 (0.00%) 
Libido increased   0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%)  1/14 (7.14%) 
Renal and urinary disorders         
Urinary hesitancy   0/16 (0.00%)  1/14 (7.14%)  0/16 (0.00%)  0/14 (0.00%) 
Reproductive system and breast disorders         
Epididymal cyst   1/16 (6.25%)  0/14 (0.00%)  0/16 (0.00%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders         
Acne   0/16 (0.00%)  0/14 (0.00%)  0/16 (0.00%)  1/14 (7.14%) 
Indicates events were collected by systematic assessment
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: NCT01386606     History of Changes
Other Study ID Numbers: ZA-204
First Submitted: June 29, 2011
First Posted: July 1, 2011
Results First Submitted: June 13, 2014
Results First Posted: September 23, 2015
Last Update Posted: September 23, 2015