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
1 other identifier
interventional
102
1 country
18
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Oct 2010
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
July 24, 2014
CompletedJuly 24, 2014
June 1, 2014
1.2 years
August 27, 2010
June 18, 2014
June 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1C
The change in HbA1c from Baseline to 3 Months for each treatment arm
3 months
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
Androxal 12.5 mg
EXPERIMENTAL12.5 mg/day
Androxal 25 mg
EXPERIMENTAL25 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Paradigm Clinical Research
Garden Grove, California, 92844, United States
Northern California Research Corp
Sacramento, California, 95821, United States
LABioMed
Torrance, California, 90502, United States
Lahey Clinic
Peabody, Massachusetts, 01960, United States
Affiliated Clinical Research
Las Vegas, Nevada, 89109, United States
Affiliated Clinical Research
Las Vegas, Nevada, 89144, United States
Dr. Bruce Gilbert
Great Neck, New York, 11021, United States
University Urology
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Dr. Michael Werner
Purchase, New York, 10577, United States
Discovery Clinical Trials
Austin, Texas, 78758, United States
Research Across America
Carrollton, Texas, 75010, United States
TX Urology Associate
Houston, Texas, 77024, United States
Centex Research
Houston, Texas, 77062, United States
Dr. Rakesh Patel
Houston, Texas, 77095, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
R/D Clinical Research
Lake Jackson, Texas, 77566, United States
Cetero Research
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer L. Wike
- Organization
- Repros Therapeutics Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn Cunningham, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2010
First Posted
August 30, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 24, 2014
Results First Posted
July 24, 2014
Record last verified: 2014-06