A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

NCTNCT01386567Other idZA-203 Extension

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 48 participants (actual)
Sponsor: Repros Therapeutics Inc. · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jul 2011
Primary completion: Jan 2013
Completion: Jan 2013
First posted: 1 Jul 2011 (estimated)
Last update posted: 17 May 2013 (estimated)
Conditions: Hypogonadism · Low Testosterone

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2011201220132014

Ph 2
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
NCT01386567
Jul 2011 to Jan 2013

Registry summary

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

The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.

Interventions

Androxal (enclomiphene citrate)Drug
Testim (topical testosterone)Drug

Arms2

Experimental
Androxal
Androxal (enclomiphene citrate)12.5 mg or 25 mg
Active comparator
Testim (topical testosterone)

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in testosterone comparing Androxal to Testim
Time frame · 1 year
Registry description
Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim

Secondary outcomes(2)

Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Time frame · 1 year
Registry description
Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim
Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Time frame · 1 year
Registry description
Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim

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 21 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Successful completion of ZA-203 * Ability to understand and provide written informed consent * Agreement to use a condom, and with a fertile female partner, another form of contraception * Agreement to provide semen samples in the clinic Exclusion Criteria: * Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

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