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NCT01532414 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Repros Therapeutics.

Completed
Registry status
Phase 3
Development phase
151
Enrollment target

NCT01532414 is a Phase 3 study that has completed, run by Repros Therapeutics. The registered enrollment target is 151 participants.

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The verdict

NCT01532414, a Phase 3 study, has completed, sponsored by Repros Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
151 participants
Enrollment target

Study Summary

The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.

Interventions

  • DRUG Placebo
  • DRUG Androxal

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2012-08
Est. Completion 2013-03
Phase Phase 3

Sponsor

Repros Therapeutics

50 total trials

What the Registry Record Tells You About NCT01532414

The ClinicalTrials.gov registry entry for NCT01532414 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 151 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 Placebo is the first listed.

NCT01532414 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01532414 about?

NCT01532414 is a clinical study titled "Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism". The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not hav...

What is the current status of trial NCT01532414?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2012-08. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01532414?

The interventions under investigation include: Placebo (DRUG), Androxal (DRUG).

Who is sponsoring clinical trial NCT01532414?

This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.