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Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

NCT01534208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2014-07-24

Study results available
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Summary

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Conditions

  • Secondary Hypogonadism

Interventions

DRUG

Androxal

Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph S Podolski · Repros Therapeutics Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01534208 on ClinicalTrials.gov