Neoplasms

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hypogonadism

Neoplastic Processes

Gonadal Disorders

Endocrine System Diseases

Anticoagulants

All Drugs and Chemicals

Reproductive Control Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Citrate

Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal

Joseph S Podolski

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.

Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Changes in values from baseline of total morning testosterone levels at Week 26

Mean change from baseline in LH at end of treatment (26 weeks)

Absolute values of morning testosterone at end of treatment (26 weeks)

Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)

Mean change from baseline in BMI at end of treatment (26 weeks)

Change from baseline in FSH at end of treatment (26 weeks)

Repros Therapeutics Inc.

Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 12.5 mg

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Jennifer Wike

Change From Baseline in Total Morning Testosterone at 26 Weeks

Change From Baseline in LH

Absolute Values of Morning Testosterone

Mean Change From Baseline FPG

Change From Baseline in BMI

Change From Baseline in FSH

Androxal 12.5 mg daily

Androxal, oral, 12.5 mg capsule, taken once daily

Androxal 25 mg daily

Androxal, oral, 25 mg capsule, taken once daily

Overall Study

Antineoplastic Agents

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Androgens

Placebo

testosterone gel applied 1x daily for 3 months

topical testosterone

Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Larry Lipshultz, MD

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim

Changes in values from baseline in LH at month 3

Change from baseline in sperm concentration

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Testim (Topical Testosterone)

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Race (NIH/OMB)

Jennifer L. Wike

Intent to treat subjects with an assessment after baseline

Change in Total Morning Testosterone

Change in Luteinizing Hormone Levels

Change in FSH After 3 Months of Treatment

Reproductive Safety

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Chelating Agents

5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.

AndroGel

Andre van As, MD, PhD

Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.

Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

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.

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

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.

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

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

Values of total morning testosterone levels at each visit

Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit

Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes

Nutritional and Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Metabolic Diseases

Glucose Metabolism Disorders

Capsules 12.5 mg or 25 mg 1x daily for 3 months

Glenn Cunningham, MD

The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism

A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in adult male subjects with secondary hypogonadism who have been treated with OHAs but are not in glycemic control. All subjects currently treated with exogenous testosterone will discontinue at screening for at least 21 days and remain off testosterone for the course of the study. One hundred twenty to 150 subjects will be randomly assigned to one of three treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three months. Following an initial screening period, subjects will return monthly for 3 months and 1 month later for a follow-up visit.

Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus

A Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment

The change in HbA1c from Baseline to 3 Months for each treatment arm

12.5 mg/day

Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months

25 mg/day

Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months

HgbA1c ratio

Change in HbA1C

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism

An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism	NCT01534208	Secondary Hypog...	Androxal	18 Years - 65 Years	Repros Therapeutics Inc.
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism	NCT01270841	Secondary Hypog...	Placebo topical testost... Androxal	21 Years - 65 Years	Repros Therapeutics Inc.
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism	NCT00962637	Secondary Hypog...	Androxal Androxal AndroGel Placebo	18 Years - 68 Years	Repros Therapeutics Inc.
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism	NCT00962637	Secondary Hypog...	Androxal Androxal AndroGel Placebo	18 Years - 68 Years	Repros Therapeutics Inc.
Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism	NCT01534208	Secondary Hypog...	Androxal	18 Years - 65 Years	Repros Therapeutics Inc.
An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism	NCT01739582	Secondary Hypog...	Androxal	18 Years - 60 Years	Repros Therapeutics Inc.
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus	NCT01191320	Type 2 Diabetes... Secondary Hypog...	Placebo Androxal	20 Years - 80 Years	Repros Therapeutics Inc.
Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism	NCT01067365	Secondary Hypog...	Androxal Androxal	18 Years - 68 Years	Repros Therapeutics Inc.

Spots Global Cancer Trial Database for androxal

Every month we try and update this database with for androxal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for androxal

Every month we try and update this database with for androxal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for androxal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.