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Completed

NCT Number: NCT01739582

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

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

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Key information

Conditions

Secondary Hypogonadism Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Androxal

Drug

Other names: enclomiphene citrate

Primary outcomes

  1. Testosterone levels

    Time frame: 26 weeks

    Values of total morning testosterone levels at each visit

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Repros Therapeutics Inc.

Industry

Registry information

Official study title

An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2012
Registry last updated
Apr 16, 2014

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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