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Trial record 65 of 213 for:    "Hypogonadism" | "Androgens"

Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism

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: NCT01532414
Recruitment Status : Completed
First Posted : February 14, 2012
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Secondary Hypogonadism
Interventions Drug: Androxal
Drug: Placebo
Enrollment 151
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Androxal 12.5 mg Androxal 25 mg Placebo
Hide Arm/Group Description

Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day

Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months

Period Title: Overall Study
Started 92 21 [1] 38
Completed 85 19 35
Not Completed 7 2 3
Reason Not Completed
Lost to Follow-up             3             0             1
Withdrawal by Subject             3             0             0
No V6 semen sample             0             1             0
Adverse Event             0             1             1
Unable to complete 24 hour PK             0             0             1
Withdrawn by sponsor             1             0             0
[1]
Up-titrated at 6 weeks from a starting dose of 12.5 mg due to morning testosterone <300 ng/dL
Arm/Group Title Androxal 12.5 mg Androxal 25 mg Placebo Total
Hide Arm/Group Description

Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day

Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months

Total of all reporting groups
Overall Number of Baseline Participants 92 21 38 151
Hide Baseline Analysis Population Description
Analyses were conducted on the following populations: ITT (all subjects enrolled), mITT (all ITT subjects except site 09), PP (all ITT subjects who completed Week 12) and Safety (all subjects who received any study drug)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 21 participants 38 participants 151 participants
47.2  (9.6) 43.6  (10.1) 47.8  (9.5) 46.9  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 21 participants 38 participants 151 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
92
 100.0%
21
 100.0%
38
 100.0%
151
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 21 participants 38 participants 151 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.2%
0
   0.0%
2
   5.3%
4
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  12.0%
1
   4.8%
0
   0.0%
12
   7.9%
White
79
  85.9%
20
  95.2%
36
  94.7%
135
  89.4%
More than one race
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%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 92 participants 21 participants 38 participants 151 participants
92 21 38 151
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 92 participants 21 participants 38 participants 151 participants
31.5  (4.3) 32.8  (5.0) 31.3  (3.8) 31.6  (4.3)
1.Primary Outcome
Title Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range
Hide Description

Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.

If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved.

FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment was not calculated.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Androxal Treated Subjects Pooled
Hide Arm/Group Description:

Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Overall Number of Participants Analyzed 113
Overall Number of Units Analyzed
Type of Units Analyzed: 12.5 and 25 mg pooled
113
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects
78.8
(70.3 to 85.3)
2.Primary Outcome
Title Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm
Hide Description

Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.

The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT.
Arm/Group Title Androxal Subjects Pooled Placebo
Hide Arm/Group Description:

Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months

Overall Number of Participants Analyzed 113 38
Measure Type: Number
Unit of Measure: percentage of participants
14.2 2.6
Time Frame For subjects not up-titrated 13 weeks (one week follow up after end of treatment). For subjects up-titrated 18 weeks plus one week of follow up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Androxal 12.5 mg Androxal 25 mg Placebo
Hide Arm/Group Description

Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months

All-Cause Mortality
Androxal 12.5 mg Androxal 25 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Androxal 12.5 mg Androxal 25 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   0/21 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Androxal 12.5 mg Androxal 25 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/92 (5.43%)   6/21 (28.57%)   4/38 (10.53%) 
Cardiac disorders       
Palpitations  1  0/92 (0.00%)  1/21 (4.76%)  1/38 (2.63%) 
Eye disorders       
Ocular discomfort  1  0/92 (0.00%)  1/21 (4.76%)  0/38 (0.00%) 
Gastrointestinal disorders       
Nausea  1  0/92 (0.00%)  0/21 (0.00%)  2/38 (5.26%) 
Infections and infestations       
Upper respiratort tract infection  1  5/92 (5.43%)  1/21 (4.76%)  0/38 (0.00%) 
Nervous system disorders       
Headache  1  3/92 (3.26%)  2/21 (9.52%)  2/38 (5.26%) 
Vascular disorders       
Hypertension  1  1/92 (1.09%)  1/21 (4.76%)  0/38 (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.
Investigator shall submit a copy of proposed publication. Sponsor shall have sixty (60) days (or such longer period as Sponsor shall determine is necessary) to review the proposed publication and, upon request, Investigator shall delete any of Sponsor’s Confidential Information or withhold submission of such publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer L Wike, Director of Regulatory Affairs
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: NCT01532414     History of Changes
Other Study ID Numbers: ZA-301
First Submitted: February 9, 2012
First Posted: February 14, 2012
Results First Submitted: June 13, 2014
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015