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

Repros Therapeutics

Status and phase: Completed; Phase 2

Conditions: Low Testosterone; Hypogonadism

Treatments: Drug: Androxal (enclomiphene citrate); Drug: Testim (topical testosterone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01386567

ZA-203 Extension

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Androxal

Experimental group

Description:

Androxal (enclomiphene citrate)12.5 mg or 25 mg

Treatment:

Drug: Androxal (enclomiphene citrate)

Testim (topical testosterone)

Active Comparator group

Treatment:

Drug: Testim (topical testosterone)