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Trial record 16 of 51 for:    "Hypogonadism" | "Estrogens"

To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

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ClinicalTrials.gov Identifier: NCT00706719
Recruitment Status : Completed
First Posted : June 27, 2008
Results First Posted : October 8, 2010
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Secondary Hypogonadism
Interventions Drug: 25 mg Androxal
Drug: Testim 1%
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Testim (Topical Testosterone) Group B Androxal no Washout Group C Androxal With Wash Out
Hide Arm/Group Description 1% Testim gel applied once daily 25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone 25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone
Period Title: Overall Study
Started 5 7 5
Completed 5 6 1
Not Completed 0 1 4
Arm/Group Title Group A Testim Group B Androxal no Wash Out Group C Androxal Wash Out Total
Hide Arm/Group Description 1% Testim gel applied daily 25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months 25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone Total of all reporting groups
Overall Number of Baseline Participants 5 7 5 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 5 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
7
 100.0%
5
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 7 participants 5 participants 17 participants
54.4  (4.88) 48.9  (8.99) 56.4  (23.8) 52.7  (7.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 5 participants 17 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
7
 100.0%
5
 100.0%
17
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 7 participants 5 participants 17 participants
5 7 5 17
1.Primary Outcome
Title Sperm Concentration
Hide Description Total sperm concentration was measured.
Time Frame Baseline, Month 3, Month 6, Follow-Up (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
Arm/Group Title Group A Testim Group B Androxal no Wash Out
Hide Arm/Group Description:
1% Testim gel applied daily
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: millions sperm/mL
Baseline 0.54  (0.74) 72.8  (92.7)
Month 3 3.00  (5.20) 182.6  (115.5)
Month 6 23.14  (30.67) 168.5  (92.9)
Follow-Up (Month 7) 21.03  (28.90) 164.0  (71.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Follow-up (Month 7).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Motile Total Sperm Count
Hide Description Motile total sperm count was measured.
Time Frame Baseline, Month 3, Month 6, Follow-Up (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
Arm/Group Title Group A Testim Group B Androxal no Wash Out
Hide Arm/Group Description:
1% Testim gel applied daily
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: millions sperm
Baseline 0.3  (0.48) 99.0  (159.6)
Month 3 2.42  (5.41) 214.7  (166.0)
Month 6 40.4  (55.3) 146.9  (120.0)
Follow-Up (Month 7) 38  (52.5) 100.3  (103.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Follow-up (Month 7).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Semen Volume
Hide Description Semen volume was measured.
Time Frame Baseline, Month 3, Month 6, Follow-Up (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
Arm/Group Title Group A Testim Group B Androxal no Wash Out
Hide Arm/Group Description:
1% Testim gel applied daily
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mL
Baseline 2.34  (1.43) 2.23  (0.81)
Month 3 2.88  (1.40) 2.45  (1.31)
Month 6 1.90  (1.03) 2.48  (1.53)
Follow-Up (Month 7) 3.34  (0.83) 2.40  (0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.880
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.612
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.488
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Follow-up (Month 7).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Luteinizing Hormone (LH) Levels
Hide Description LH levels were measured.
Time Frame Baseline, Month 3, Month 6, Follow-Up (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
Arm/Group Title Group A Testim Group B Androxal no Wash Out
Hide Arm/Group Description:
1% Testim gel applied daily
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mIU/mL
Baseline 3.40  (2.14) 2.92  (1.69)
Month 3 0.88  (1.39) 5.70  (3.22)
Month 6 0.60  (0.58) 6.12  (3.15)
Follow-Up (Month 7) 2.68  (0.48) 2.47  (1.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Follow-up (Month 7).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.808
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Follicle Stimulating Hormone (FSH) Levels
Hide Description FSH levels were measured.
Time Frame Baseline, Month 3, Month 6, Follow-Up (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
Arm/Group Title Group A Testim Group B Androxal no Wash Out
Hide Arm/Group Description:
1% Testim gel applied daily
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mIU/mL
Baseline 3.38  (0.74) 1.58  (0.74)
Month 3 1.06  (1.12) 4.53  (2.36)
Month 6 0.9  (0.51) 5.48  (2.46)
Follow-Up (Month 7) 3.6  (1.20) 2.38  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Month 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group A Testim, Group B Androxal no Wash Out
Comments Comparison of Group A and B observed values at Follow-up (Month 7).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Testim Group B Androxal no Wash Out Androxal Wash Out
Hide Arm/Group Description 1% Testim gel applied daily 25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months 25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
All-Cause Mortality
Group A Testim Group B Androxal no Wash Out Androxal Wash Out
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group A Testim Group B Androxal no Wash Out Androxal Wash Out
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/7 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Testim Group B Androxal no Wash Out Androxal Wash Out
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      2/7 (28.57%)      4/5 (80.00%)    
Eye disorders       
erythema *  0/5 (0.00%)  0 0/7 (0.00%)  0 1/5 (20.00%)  1
blurred vision *  0/5 (0.00%)  0 1/7 (14.29%)  1 0/5 (0.00%)  0
Gastrointestinal disorders       
diarrhea * 1  0/5 (0.00%)  0 0/7 (0.00%)  0 1/5 (20.00%)  1
General disorders       
fatigue *  0/5 (0.00%)  0 0/7 (0.00%)  0 1/5 (20.00%)  1
Psychiatric disorders       
worsening depression *  0/5 (0.00%)  0 0/7 (0.00%)  0 1/5 (20.00%)  1
Vascular disorders       
vasomotor flushing *  0/5 (0.00%)  0 1/7 (14.29%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Gastrointestinal
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ronald Wiehle, PhD
Organization: Repros Therapeutics, Inc
Phone: 281.719.3406
EMail: rwiehle@reprosrx.com
Layout table for additonal information
Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00706719     History of Changes
Other Study ID Numbers: ZA-201
First Submitted: June 25, 2008
First Posted: June 27, 2008
Results First Submitted: August 25, 2010
Results First Posted: October 8, 2010
Last Update Posted: August 19, 2015