- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01191320
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
June 27, 2014 updated by: Repros Therapeutics Inc.
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 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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Garden Grove, California, United States, 92844
- Paradigm Clinical Research
-
Sacramento, California, United States, 95821
- Northern California Research Corp
-
Torrance, California, United States, 90502
- LABioMed
-
-
Massachusetts
-
Peabody, Massachusetts, United States, 01960
- Lahey Clinic
-
-
Nevada
-
Las Vegas, Nevada, United States, 89109
- Affiliated Clinical Research
-
Las Vegas, Nevada, United States, 89144
- Affiliated Clinical Research
-
-
New York
-
Great Neck, New York, United States, 11021
- Dr. Bruce Gilbert
-
New York, New York, United States, 10029
- Mount Sinai School of Medicine
-
New York, New York, United States, 10016
- University Urology
-
Purchase, New York, United States, 10577
- Dr. Michael Werner
-
-
Texas
-
Austin, Texas, United States, 78758
- Discovery Clinical Trials
-
Carrollton, Texas, United States, 75010
- Research Across America
-
Houston, Texas, United States, 77062
- Centex Research
-
Houston, Texas, United States, 77024
- TX Urology Associate
-
Houston, Texas, United States, 77095
- Dr. Rakesh Patel
-
Hurst, Texas, United States, 76054
- Protenium Clinical Research
-
Lake Jackson, Texas, United States, 77566
- R/D Clinical Research
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San Antonio, Texas, United States, 78229
- Cetero Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Males, ages 20 to 80-years-old, inclusive
- A diagnosis of type 2 diabetes mellitus by American Diabetes Association (ADA) criteria for at least 6 months
- Treatment with a stable but sub-optimum dose of OHAs for at least 2 months prior to screening based on a lack of control of blood glucose
- Previous diagnosis of adult-onset idiopathic hypogonadotropic hypogonadism (AIHH) and have undergone treatment with a topical testosterone gel, Low-to-borderline morning total testosterone (TT), after at least a two week wash-out period, and normal or low normal serum luteinizing hormone (LH)at screening and at baseline
- No previous diagnosis of AIHH but present as naïve patients with low morning TT and normal or low normal serum LH at screening and at baseline
- Body Mass Index (BMI) between 26 and 40 kg/m2
- Fasting blood (plasma or serum) glucose (FBG) between 125 and 240 mg/dL
- HemoglobinA1c in serum as (HbA1c) between 7% and 9.5%
- Comprehends informed consent
- Otherwise normal healthy males
- All clinical laboratory test within normal ranges (any deviation outside the normal range will require approval of investigator)
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
Exclusion Criteria:
- A history of testicular failure, Kallmann Syndrome or other infertility condition
- Clinically significant medical condition rendering the subjects infertile including tumors of the pituitary, laboratory abnormalities, or having received an investigational drug in the past 30 days prior to study
- Prostate nodules or induration, a history of, known, or suspect prostate cancer not ruled out by a negative biopsy, or a prostate specific antigen (PSA) higher than 3.5;
- Hematocrit in excess of 47% or a hemoglobin (Hb) greater than 16 g/dl
- Previous treatment with androgens, estrogens, DHEA, testosterone or testosterone analogues in injectable, oral, topical or other forms for the treatment of AIHH who have not discontinued at the start of the treatment phase;
- Primary hypogonadism as typified as a serum LH greater than 15 and a TT value less than 300 ng/dL
- Continuous use of corticosteroids
- History of or current diagnosis of major macrovascular complications of T2DM: myocardial infarction (MI) or stroke within 6 months, or any history of coronary revascularization, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) greater than or equal to 2
- Uncontrolled sitting blood pressure (BP) greater than 150/95, serum creatinine (Cr) greater than 1.5 ULN or estimated glomerular filtration rate (eGFR) less than mL/min/1.73 m2
- Retinopathy requiring continuing ophthalmologic assessments
- Cataracts
- Other significant history of diabetic complications (proteinuria greater than 1 g/d, retinopathy, clear neuropathy)
- Aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than 3 times the upper limits of normal (ULN)
- Total bilirubin greater than 2.0 mg/dL (>34 µmol/L);
- Injectable testosterone within 120 days of Screening (Visit 1)
- Reported substance abuse at screening
- Taking insulin therapy;
- Clinically significant abnormal findings on screening examination as determined by the investigator
- Known hypersensitivity to clomiphene citrate;
- Current or history of breast cancer
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with the study instructions, possibly confound interpretation of the study results, or endanger the participant if he took part in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo capsule 1x daily for 3 months
|
Experimental: Androxal 12.5 mg
12.5 mg/day
|
Capsules 12.5 mg or 25 mg 1x daily for 3 months
Other Names:
|
Experimental: Androxal 25 mg
25 mg/day
|
Capsules 12.5 mg or 25 mg 1x daily for 3 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1C
Time Frame: 3 months
|
The change in HbA1c from Baseline to 3 Months for each treatment arm
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Glenn Cunningham, MD, Baylor College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 27, 2010
First Submitted That Met QC Criteria
August 27, 2010
First Posted (Estimate)
August 30, 2010
Study Record Updates
Last Update Posted (Estimate)
July 24, 2014
Last Update Submitted That Met QC Criteria
June 27, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Neoplasms
- Endocrine System Diseases
- Gonadal Disorders
- Neoplastic Processes
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Neoplasm Metastasis
- Hypogonadism
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Estrogen Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Clomiphene
- Enclomiphene
- Zuclomiphene
Other Study ID Numbers
- ZA-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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