Back to resultsA One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
Primary Purpose
Hypogonadism, Low Testosterone
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Androxal (enclomiphene citrate)
Testim (topical testosterone)
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring hypogonadism, low testosterone, low T
Eligibility Criteria
Inclusion Criteria:
- Successful completion of ZA-203
- Ability to understand and provide written informed consent
- Agreement to use a condom, and with a fertile female partner, another form of contraception
- Agreement to provide semen samples in the clinic
Exclusion Criteria:
- Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Androxal
Testim (topical testosterone)
Arm Description
Androxal (enclomiphene citrate)12.5 mg or 25 mg
Outcomes
Primary Outcome Measures
Change in testosterone comparing Androxal to Testim
Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
Secondary Outcome Measures
Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim
Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01386567
Brief Title
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
Official Title
A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Low Testosterone
Keywords
hypogonadism, low testosterone, low T
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Androxal
Arm Type
Experimental
Arm Description
Androxal (enclomiphene citrate)12.5 mg or 25 mg
Arm Title
Testim (topical testosterone)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Androxal (enclomiphene citrate)
Other Intervention Name(s)
enclomiphene citrate
Intervention Description
capsules oral 1x a day
1 year
Intervention Type
Drug
Intervention Name(s)
Testim (topical testosterone)
Other Intervention Name(s)
topical testosterone, exogenous testosterone, testosterone gel
Intervention Description
topical
1 tube
1x a day
1 year
Primary Outcome Measure Information:
Title
Change in testosterone comparing Androxal to Testim
Description
Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Description
Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim
Time Frame
1 year
Title
Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Description
Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Successful completion of ZA-203
Ability to understand and provide written informed consent
Agreement to use a condom, and with a fertile female partner, another form of contraception
Agreement to provide semen samples in the clinic
Exclusion Criteria:
Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Facility Information:
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.reprosrx.com
Description
Sponsor website
URL
http://helpmylowT.com
Description
Study information
Learn more about this trial
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
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