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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Insulin Resistance and Testosterone in Women

NCTNCT00123110 (opens ClinicalTrials.gov in a new tab)Other idAG0031Other idK23AG019161Other idK23AG1916101A1Other id5P30DK019525

Overview

Status
Completed
Phase
Phase 2
Enrollment
35 participants (actual)
Sponsor
University of Pennsylvania · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jul 2005
Primary completion
Dec 2011
Completion
Dec 2011
First posted
22 Jul 2005 (estimated)
Last update posted
23 May 2019
Conditions
Insulin Resistance · Postmenopause

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 2

    Insulin Resistance and Testosterone in Women

    NCT00123110

    Jul 2005 to Dec 2011

Registry summary

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

The purpose of this research study is to determine if a relationship between insulin resistance (IR) and testosterone (T) exists in women who have already gone through menopause.

Interventions

  • metforminDrug
  • leuprolide injectionDrug
  • placebo pillDrug
  • placebo injectionDrug

Arms3

  • Experimental

    1

    metformin pill plus placebo injection

  • Experimental

    2

    leuprolide injection plus placebo pill

  • Placebo comparator

    3

    placebo pill plus placebo injection

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percent Change in Free Testosterone (T)

    Time frame · Baseline to 12 weeks

    Registry description

    Percent change in free T by equilibrium dialysis between baseline and 12 weeks

  2. Change in Insulin Sensitivity

    Time frame · baseline and 12 weeks

    Registry description

    Change in insulin sensitivity (mg/kg/min) calculated from hyperinsulinemic euglycemic clamp

Secondary outcomes(7)
  1. Percent Change in Luteinizing Hormone (LH) From Baseline

    Time frame · baseline and 12 weeks

  2. Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR)

    Time frame · baseline and 12 weeks

    Registry description

    Insulin resistance calculated from homeostasis model assessment of insulin resistance (HOMA-IR) equation: fasting insulin x fasting glucose / 405. Higher values indicate more insulin resistance.

  3. Percent Change in Low Density Lipoprotein (LDL)

    Time frame · baseline and 12 weeks

  4. Percent Change in Systolic Blood Pressure

    Time frame · baseline and 12 weeks

  5. Free T and IR in Women in Whom Metabolic Syndrome is Present vs. Absent

    Time frame · baseline and 12 weeks

  6. Dehydroepiandrosterone Sulfate (DHEA-S)

    Time frame · baseline and 12 weeks

  7. Body Mass Index (BMI)

    Time frame · baseline and 12 weeks

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· Baseline to 12 weeks

Percent Change in Free Testosterone (T)

GroupValue (percent change)Spread
Metformin-6.922.8
Leuprolide-35.831.8
Placebo12.117.8
Primary outcomeMean· baseline and 12 weeks

Change in Insulin Sensitivity

GroupValue (mg/kg/min)Spread
Metformin0.440.80
Leuprolide0.040.81
Placebo-0.080.73
Secondary and other outcome results(6)
Secondary outcomeMedian· baseline and 12 weeks

Percent Change in Luteinizing Hormone (LH) From Baseline

GroupValue (percent change)
Metformin4.6
Leuprolide-96.5
Placebo-1.2
Secondary outcomeMean· baseline and 12 weeks

Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR)

GroupValue (percent change)Spread
Metformin-31.024.39
Leuprolide-8.1835.3
Placebo4.6738.16
Secondary outcomeMean· baseline and 12 weeks

Percent Change in Low Density Lipoprotein (LDL)

GroupValue (percent change)Spread
Metformin-10.822.2
Leuprolide5.319.3
Placebo25.350.8
Secondary outcomeMean· baseline and 12 weeks

Percent Change in Systolic Blood Pressure

GroupValue (percent change)Spread
Metformin-4.28.6
Leuprolide4.013.6
Placebo-0.38.6
Secondary outcome· baseline and 12 weeks

Free T and IR in Women in Whom Metabolic Syndrome is Present vs. Absent

GroupValue
Metforminnot posted
Leuprolidenot posted
Placebonot posted
Secondary outcomeMedian· baseline and 12 weeks

Dehydroepiandrosterone Sulfate (DHEA-S)

GroupValue (percent change)
Metformin2.6
Leuprolide0.9
Placebo-2.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Metforminmetformin plus leuprolide placebo (LP) injection0 / 120 / 120 / 12
Leuprolideleuprolide plus metformin placebo (MP) pill0 / 120 / 120 / 12
PlaceboMP placebo pill plus LP placebo injection0 / 110 / 110 / 11

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
Female
Age
from 50 Years up to 79 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Postmenopausal women aged 50-79 years with absence of menses for 12 months; for women 50-54 years, Follicle stimulating hormone\>30 U/mL to confirm postmenopausal status * At least one intact ovary * Free testosterone and fasting insulin levels within required study parameters * Willing to comply with all study-related procedures * Capable of giving informed consent Exclusion Criteria: * History of cancer requiring treatment within the past 5 years (exceptions may be made by investigator) * Hospitalization for treatment of vascular disease in the past 6 months * Uncontrolled hypertension * Hospitalization for chronic obstructive pulmonary disease or asthma in the past 3 months * Use of continuous oxygen at home * Surgery in the last 30 days * Positive for HIV * Abnormal blood tests (hemoglobin, fasting triglycerides, fasting glucose, creatinine, liver function) * History of diabetes mellitus or use of any anti-hyperglycemic medication in the past 3 months * Disease associated with disordered glucose metabolism (Cushing's disease, acromegaly, pheochromocytoma not surgically cured, chronic pancreatitis) * History of chronic renal insufficiency * Intravenous (IV) contrast studies with iodinated materials planned for the 12 week intervention period that cannot be postponed according to the participant's primary care provider * Acute or chronic metabolic acidosis * History of liver disease * Congestive heart failure * History of androgen-secreting tumors * Hormone replacement therapy or antiandrogen use in past 6 months * Use of dehydroepiandosterone (DHEA) or other androgen-containing products in past 6 months * Corticosteroid use, other than topical, ophthalmic, intraarticular, and inhaled preparations, in past 3 months * Undiagnosed current vaginal bleeding * Excessive alcohol intake, either acute or chronic; current illicit substance abuse * Participation in an investigational drug study within 6 weeks prior to screening visit * Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study

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