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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypogonadism Low Testosterone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Androxal

Androxal (enclomiphene citrate)12.5 mg or 25 mg

Group Type EXPERIMENTAL

Androxal (enclomiphene citrate)

Intervention Type DRUG

capsules oral 1x a day

1 year

Testim (topical testosterone)

Group Type ACTIVE_COMPARATOR

Testim (topical testosterone)

Intervention Type DRUG

topical

1 tube

1x a day

1 year

Interventions

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Androxal (enclomiphene citrate)

capsules oral 1x a day

1 year

Intervention Type DRUG

Testim (topical testosterone)

topical

1 tube

1x a day

1 year

Intervention Type DRUG

Other Intervention Names

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enclomiphene citrate topical testosterone exogenous testosterone testosterone gel

Eligibility Criteria

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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