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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
102 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Oct 2010
Primary completion
Dec 2011
Completion
Dec 2011
First posted
30 Aug 2010 (estimated)
Last update posted
24 Jul 2014 (estimated)
Conditions
Type 2 Diabetes Mellitus · Secondary Hypogonadism

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 2

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

    NCT01191320

    Oct 2010 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PlaceboDrug
  • AndroxalDrug

Arms3

  • Placebo comparator

    Placebo

    Placebo

  • Experimental

    Androxal 12.5 mg

    12.5 mg/day

  • Experimental

    Androxal 25 mg

    25 mg/day

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1C

    Time frame · 3 months

    Registry description

    The change in HbA1c from Baseline to 3 Months for each treatment arm

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months

Change in HbA1C

GroupValue (Ratio)Spread
Placebo00.012
Androxal 12.5 mg00.015
Androxal 25 mg00.010

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboPlacebo Placebo: Placebo capsule 1x daily for 3 months–1 / 431 / 43
Androxal 12.5 mg12.5 mg/day Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months–0 / 388 / 38
Androxal 25 mg25 mg/day Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months–1 / 385 / 38

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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