Exploratory Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus and Secondary Hypogonadism or Adult-Onset Idiopathic Hypogonadotropic Hypogonadism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01191320
First received: August 27, 2010
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Secondary Hypogonadism
Drug: Placebo
Drug: enclomiphene citrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel, Double-blind, Placebo-controlled Exploratory 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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Change in HbA1C [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The change in HbA1c from Baseline to 3 Months for each treatment arm


Enrollment: 102
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo capsule 1x daily for 3 months
Experimental: Androxal 12.5 mg Drug: enclomiphene citrate
capsules 12.5 mg or 25 mg 1x daily for 3 months
Experimental: Androxal 25 mg Drug: enclomiphene citrate
capsules 12.5 mg or 25 mg 1x daily for 3 months

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191320

Locations
United States, California
Paradigm Clinical Research
Garden Grove, California, United States, 92844
Northern California Research Corp
Sacramento, California, United States, 95821
LABioMed
Torrance, California, United States, 90502
United States, Massachusetts
Lahey Clinic
Peabody, Massachusetts, United States, 01960
United States, Nevada
Affiliated Clinical Research
Las Vegas, Nevada, United States, 89109
Affiliated Clinical Research
Las Vegas, Nevada, United States, 89144
United States, New York
Dr. Bruce Gilbert
Great Neck, New York, United States, 11021
Mount Sinai School of Medicine
New York, New York, United States, 10029
University Urology
New York, New York, United States, 10016
Dr. Michael Werner
Purchase, New York, United States, 10577
United States, Texas
Discovery Clinical Trials
Austin, Texas, United States, 78758
Research Across America
Carrollton, Texas, United States, 75010
Dr. Rakesh Patel
Houston, Texas, United States, 77095
TX Urology Associate
Houston, Texas, United States, 77024
Centex Research
Houston, Texas, United States, 77062
Protenium Clinical Research
Hurst, Texas, United States, 76054
R/D Clinical Research
Lake Jackson, Texas, United States, 77566
Cetero Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Principal Investigator: Glenn Cunningham, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01191320     History of Changes
Other Study ID Numbers: ZA-202
Study First Received: August 27, 2010
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Adult onset hypogonadotropic hypogonadism

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypogonadism
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gonadal Disorders
Clomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on July 22, 2014