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COMPLETED Phase 3

Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism

NCT01067365 · View on ClinicalTrials.gov ↗

Study Summary

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

Conditions Studied

Interventions

  • DRUG Androxal

Study Locations (18)

California

  • Northern California Research Corp — Carmichael
  • Prime-Care Clinical Research — Mission Viejo
  • Harbor-UCLA Medical Center — Torrance

Alabama

  • Alabama Clinical Therapeutics, LLC — Birmingham
  • Medial Affiliated Research Center, Inc. — Huntsville

Nevada

  • Office of Michael Mall, MD — Las Vegas
  • Office of Stephen Miller, MD — Las Vegas

New Jersey

  • Advanced Biomedical Research, Inc. — Hackensack
  • Office of Gary S. Karlin, MD — Lawrenceville

Connecticut

  • Chase Medical Research, LLC — Waterbury

Florida

  • Southeastern Research Group, Inc. — Tallahassee

Indiana

  • Northeast Indiana Research, LLC — Fort Wayne

Kentucky

  • Commonweatlh Biomedical Research — Madisonville

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2006-03
Est. Completion 2007-05
Phase Phase 3

Sponsor

Repros Therapeutics

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01067365

The ClinicalTrials.gov registry entry for NCT01067365 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Secondary Hypogonadism appearing as the primary indexed condition, and to 1 intervention — of which Androxal is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01067365 reports 18 study locations spanning 13 distinct geographic areas — top geographies include California, Alabama, Nevada. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01067365 about?

NCT01067365 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism". Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

What is the current status of trial NCT01067365?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2006-03. Estimated completion is 2007-05.

What conditions does trial NCT01067365 study?

This clinical trial studies the following conditions: Secondary Hypogonadism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01067365?

The interventions under investigation include: Androxal (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01067365?

This trial is sponsored by Repros Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01067365 being conducted?

This trial has 18 study locations across Alabama, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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