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

NCT01532414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2015-05-27

Study results available
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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.

Conditions

  • Secondary Hypogonadism

Interventions

DRUG

Androxal

oral, capsules, taken one time daily, for 3 months

DRUG

Placebo

Oral capsule taken one time daily for 3 months

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph S Podolski · Repros Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01532414 on ClinicalTrials.gov