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Trial record 15 of 51 for:    "Hypogonadism" | "Estrogens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01386567
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : May 17, 2013
Information provided by (Responsible Party):
Repros Therapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Hypogonadism Low Testosterone Drug: Androxal (enclomiphene citrate) Drug: Testim (topical testosterone) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
Study Start Date : July 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Androxal
Androxal (enclomiphene citrate)12.5 mg or 25 mg
Drug: Androxal (enclomiphene citrate)

capsules oral 1x a day

1 year

Other Name: enclomiphene citrate

Active Comparator: Testim (topical testosterone) Drug: Testim (topical testosterone)


1 tube

1x a day

1 year

Other Names:
  • topical testosterone
  • exogenous testosterone
  • testosterone gel

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01386567

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United States, California
Garden Grove, California, United States, 92844
Sacramento, California, United States, 95821
San Diego, California, United States, 92108
United States, Nevada
Las Vegas, Nevada, United States, 89109
Las Vegas, Nevada, United States, 89144
United States, Texas
Houston, Texas, United States, 77024
Houston, Texas, United States, 77062
Houston, Texas, United States, 77095
Sponsors and Collaborators
Repros Therapeutics Inc.

Additional Information:
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Responsible Party: Repros Therapeutics Inc. Identifier: NCT01386567     History of Changes
Other Study ID Numbers: ZA-203 Extension
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013
Keywords provided by Repros Therapeutics Inc.:
low testosterone
low T
Additional relevant MeSH terms:
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Estrogen Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hormone Antagonists
Fertility Agents, Female