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Completed

NCT Number: NCT01386567

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

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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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders Low Testosterone

Age range

21 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Garden Grove, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Androxal (enclomiphene citrate)

Drug

capsules oral 1x a day

1 year

Other names: enclomiphene citrate

Testim (topical testosterone)

Drug

topical

1 tube

1x a day

1 year

Other names: topical testosterone, exogenous testosterone, testosterone gel

Primary outcomes

  1. Change in testosterone comparing Androxal to Testim

    Time frame: 1 year

    Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim

Secondary outcomes

  1. Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)

    Time frame: 1 year

    Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim

  2. Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Repros Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2011
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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