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An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

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: NCT01739582
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : April 16, 2014
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Brief Summary:
To determine the safety profile of Androxal in men with secondary hypogonadism.

Condition or disease Intervention/treatment Phase
Secondary Hypogonadism Drug: Androxal Phase 3

Detailed Description:
This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Androxal
Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2.
Drug: Androxal
Other Name: enclomiphene citrate

Primary Outcome Measures :
  1. Testosterone levels [ Time Frame: 26 weeks ]
    Values of total morning testosterone levels at each visit

Secondary Outcome Measures :
  1. Follicle Stimulating Hormone and Leutinizing Hormone [ Time Frame: 26 weeks ]
    Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit

  2. Diabetic Parameters [ Time Frame: 26 weeks ]
    Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes

  3. Change in weight and body mass index (BMI) [ Time Frame: 26 weeks ]
    Change in weight and BMI

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

• Successful completion of either ZA-301 or ZA-302

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Additional Information:
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Responsible Party: Repros Therapeutics Inc. Identifier: NCT01739582    
Other Study ID Numbers: ZA-301EXT
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators