A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
1 other identifier
interventional
48
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2011
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
July 1, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMay 17, 2013
May 1, 2013
1.5 years
June 29, 2011
May 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (2)
Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
1 year
Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
1 year
Study Arms (2)
Androxal
EXPERIMENTALAndroxal (enclomiphene citrate)12.5 mg or 25 mg
Testim (topical testosterone)
ACTIVE COMPARATORInterventions
capsules oral 1x a day 1 year
topical 1 tube 1x a day 1 year
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Garden Grove, California, 92844, United States
Unknown Facility
Sacramento, California, 95821, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Las Vegas, Nevada, 89144, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
Houston, Texas, 77062, United States
Unknown Facility
Houston, Texas, 77095, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2011
First Posted
July 1, 2011
Study Start
July 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
May 17, 2013
Record last verified: 2013-05