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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191320
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Information provided by (Responsible Party):
Repros Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Secondary Hypogonadism Drug: Placebo Drug: Androxal Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo capsule 1x daily for 3 months

Experimental: Androxal 12.5 mg
12.5 mg/day
Drug: Androxal
Capsules 12.5 mg or 25 mg 1x daily for 3 months
Other Name: Enclomiphene citrate

Experimental: Androxal 25 mg
25 mg/day
Drug: Androxal
Capsules 12.5 mg or 25 mg 1x daily for 3 months
Other Name: Enclomiphene citrate

Primary Outcome Measures :
  1. Change in HbA1C [ Time Frame: 3 months ]
    The change in HbA1c from Baseline to 3 Months for each treatment arm

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191320

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Sponsors and Collaborators
Repros Therapeutics Inc.
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Principal Investigator: Glenn Cunningham, MD Baylor College of Medicine
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Responsible Party: Repros Therapeutics Inc. Identifier: NCT01191320    
Other Study ID Numbers: ZA-202
First Posted: August 30, 2010    Key Record Dates
Results First Posted: July 24, 2014
Last Update Posted: July 24, 2014
Last Verified: June 2014
Keywords provided by Repros Therapeutics Inc.:
Adult onset hypogonadotropic hypogonadism
Additional relevant MeSH terms:
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Neoplasm Metastasis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Gonadal Disorders
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators