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

Hypogonadism Clinical Trial

Official title:

A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386567
• Other study ID #: ZA-203 Extension
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2011
• Last updated: May 16, 2013
• Start date: July 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Low Testosterone

Intervention

Drug:
• Androxal (enclomiphene citrate)
capsules oral 1x a day 1 year
• Testim (topical testosterone)
topical 1 tube 1x a day 1 year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in testosterone comparing Androxal to Testim	Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim	1 year	No
Secondary	Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)	Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim	1 year	No
Secondary	Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)	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	1 year	Yes

External Links

•   Sponsor website
•   Study information