Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
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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: NCT01534208 |
Recruitment Status :
Completed
First Posted : February 16, 2012
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
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Sponsor:
Repros Therapeutics Inc.
Information provided by (Responsible Party):
Repros Therapeutics Inc.
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Secondary Hypogonadism |
Intervention |
Drug: Androxal |
Enrollment | 499 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Androxal 12.5 mg | Androxal 25 mg |
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Androxal 12.5 mg daily Androxal, oral, 12.5 mg capsule, taken once daily |
Androxal 25 mg daily Androxal, oral, 25 mg capsule, taken once daily |
Period Title: Overall Study | ||
Started | 216 | 283 |
Completed | 159 | 234 |
Not Completed | 57 | 49 |
Reason Not Completed | ||
Lost to Follow-up | 19 | 14 |
Withdrawal by Subject | 6 | 20 |
Adverse Event | 15 | 8 |
Physician Decision | 2 | 0 |
Lack of Efficacy | 0 | 3 |
Protocol Violation | 2 | 2 |
Sponsor decision | 4 | 1 |
Subject relocation | 2 | 0 |
Lab assessment | 2 | 1 |
Eligibility error | 3 | 0 |
PCP decision | 1 | 0 |
Needed prohibited meds | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Androxal 12.5 mg | Androxal 25 mg | Total | |
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Androxal 12.5 mg daily Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated |
Androxal 25 mg daily Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated |
Total of all reporting groups | |
Overall Number of Baseline Participants | 216 | 283 | 499 | |
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Safety population
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 216 participants | 283 participants | 499 participants | |
47.5 (8.5) | 49.5 (7.7) | 48.6 (8.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 216 participants | 283 participants | 499 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
216 100.0%
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283 100.0%
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499 100.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 216 participants | 283 participants | 499 participants |
216 | 283 | 499 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Jennifer Wike |
Organization: | Repros Therapeutics Inc. |
Phone: | 2817193402 |
EMail: | jwike@reprosrx.com |
Responsible Party: | Repros Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT01534208 |
Other Study ID Numbers: |
ZA-300 |
First Submitted: | February 9, 2012 |
First Posted: | February 16, 2012 |
Results First Submitted: | June 27, 2014 |
Results First Posted: | July 24, 2014 |
Last Update Posted: | July 24, 2014 |