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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01386567

Enrollment

Registered

2011-07-01

Start date

2011-07-31

Completion date

2013-01-31

Last updated

2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism, Low Testosterone

Keywords

hypogonadism, low testosterone, low T

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.

Interventions

DRUGAndroxal (enclomiphene citrate)

capsules oral 1x a day 1 year

DRUGTestim (topical testosterone)

topical 1 tube 1x a day 1 year

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

21 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026