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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT00962637 (opens ClinicalTrials.gov in a new tab)Other idZA-003
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Overview

Status
Completed
Phase
Phase 3
Enrollment
194 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Mar 2006
Primary completion
May 2007
Completion
May 2007
First posted
20 Aug 2009 (estimated)
Last update posted
11 Feb 2010 (estimated)
Conditions
Secondary Hypogonadism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 3

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

    NCT00962637

    Mar 2006 to May 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.

Interventions

  • AndroxalDrug
  • AndroxalDrug
  • AndroGelDrug
  • PlaceboDrug

Arms4

  • Experimental

    1

    Androxal™ 12.5 mg

  • Experimental

    2

    Androxal™ 25 mg

  • Active comparator

    3

    AndroGel®

  • Placebo comparator

    4

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Evaluate the safety of Androxal™ administered in men with secondary hypogonadism

    Time frame · Six months

Secondary outcomes(1)

  1. Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®

    Time frame · Six months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 68 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 exclusion criteria may apply.

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