Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Diabetes Mellitus, Type 2

Neoplasm Metastasis

Diabetes Mellitus

Hypogonadism

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Neoplastic Processes

Gonadal Disorders

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

Placebo

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

Androxal

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

Repros Therapeutics Inc.

Placebo

Placebo: Placebo capsule 1x daily for 3 months

12.5 mg/day

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

Androxal 12.5 mg

25 mg/day

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

Androxal 25 mg

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

HgbA1c ratio

Jennifer L. Wike

Change in HbA1C

Overall Study

Spots Global Cancer Trial Database for adult onset hypogonadotropic hypogonadism