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

An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01067365

Acronym

ZA-003Ext

Enrollment

104

Registered

2010-02-11

Start date

2006-03-31

Completion date

2007-05-31

Last updated

2014-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hypogonadism

Keywords

Secondary Hypogonadism

Brief summary

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

Detailed description

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

Interventions

DRUGAndroxal

12.5 mg once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 68 Years

Healthy volunteers

Inclusion criteria

* Total serum testosterone concentrations \< 300 ng/dL at baseline

Exclusion criteria

* Presence or history of prostate cancer * Elevated PSA \> 3.5 ng/mL Additional inclusion and

Design outcomes

Primary

Measure	Time frame
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism	One year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026