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NCT01386567 · ClinicalTrials.gov registry record · Phase 2
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
A Phase 2 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT01386567 is a Phase 2 study that has completed, run by Repros Therapeutics. The registered enrollment target is 48 participants.
The verdict
NCT01386567, a Phase 2 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study 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.
Interventions
- DRUG Androxal (enclomiphene citrate)
- DRUG Testim (topical testosterone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01386567
The ClinicalTrials.gov registry entry for NCT01386567 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Androxal (enclomiphene citrate) is the first listed.
NCT01386567 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01386567 about?
NCT01386567 is a clinical study titled "A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203". 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 beg...
What is the current status of trial NCT01386567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2011-07. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01386567?
The interventions under investigation include: Androxal (enclomiphene citrate) (DRUG), Testim (topical testosterone) (DRUG).
Who is sponsoring clinical trial NCT01386567?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
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