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

Phase 2

Completed

• Conditions: Hypogonadism; Low Testosterone
• Interventions: Drug: Androxal (enclomiphene citrate); Drug: Testim (topical testosterone)

• Registration Number: NCT01386567
• Lead Sponsor: Repros Therapeutics Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-30
• Study Start: 2011-07
• Study First Posted: 2011-07-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Androxal	Androxal (enclomiphene citrate)	Androxal (enclomiphene citrate)12.5 mg or 25 mg
Testim (topical testosterone)	Testim (topical testosterone)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)	1 year	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)	1 year	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