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Aromatase Inhibitor
Anastrozole for Obesity and Low Testosterone
Phase 4
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
obese men with body mass index (BMI) of ≥35 kg/m2
age between 40 to 65 years old
Must not have
pituitary or hypothalamic disease,
prostate carcinoma or elevated serum prostate specific antigen (PSA)> 4 ng/ml,
Timeline
Screening 2 days
Treatment 12 months
Follow Up 1 day
Awards & highlights
Summary
This trial is studying whether giving the drug anastrozole, which lowers estrogen levels, together with a weight-loss program, will increase testosterone levels in obese men with low testosterone levels.
Who is the study for?
Men aged 40-65 with severe obesity (BMI ≥35) and low testosterone (<300 ng/dl), who have symptoms of androgen deficiency. They must not have had recent weight fluctuations, diabetes with high blood sugar or A1C levels, bone diseases, heart problems, prostate cancer or very high PSA levels, among other exclusions.
What is being tested?
The trial is testing if anastrozole (a drug that blocks estrogen production) combined with a weight loss program can help obese men with hypogonadism. Participants will either take anastrozole or a placebo daily for a year while following diet and exercise plans.
What are the potential side effects?
Anastrozole may cause joint pain, hot flashes, weakness, sore throat, depression, nausea and vomiting. It might also lead to decreased bone mineral density which could increase the risk of fractures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man with a BMI of 35 or higher.
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I am between 40 and 65 years old.
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My average morning testosterone levels are below 300 ng/dl.
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I am a man with a BMI of 35 or higher.
Select...
I am between 40 and 65 years old.
Select...
My average morning testosterone levels are below 300 ng/dl.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition affecting my pituitary or hypothalamus.
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I have prostate cancer or my PSA level is above 4 ng/ml.
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I have severe sleep apnea that hasn't been treated.
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I do not have recent heart attacks, unstable angina, stroke, or severe heart failure.
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I need steroids or extra oxygen for my severe lung condition.
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I have had a deep vein thrombosis or pulmonary embolism.
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I have severe urinary or prostate problems with a high symptom score.
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I have had osteoporosis or a fracture from a minor injury.
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My diabetes results in high blood sugar or A1C levels.
Timeline
Screening ~ 2 days2 visits
Treatment ~ 12 months4 visits
Follow Up ~ 1 day4 visits
Screening ~ 2 days
Treatment ~ 12 months
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Lean mass
Changes in muscle strength
Changes in total hip bone mineral density (BMD)
+1 moreSecondary study objectives
Changes in bone markers
Changes in bone quality
Changes in metabolic risk factors
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Weight loss plus anastrozoleExperimental Treatment1 Intervention
Participants will take Anastrozole 1mg per day, attend behavioral classes conducted by a dietitian, receive instruction on how to loss 10% of their body weight and undergo supervised exercise training program.
Group II: Weight loss plus placeboPlacebo Group1 Intervention
Participants will take a placebo every day, attend behavioral classes conducted by a dietitian, receive instruction on how to loss 10% of their body weight and undergo supervised exercise training program.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,006 Previous Clinical Trials
6,003,188 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man with a BMI of 35 or higher.I do not have conditions that affect bone health like hyperparathyroidism or osteomalacia.I do not have recent heart attacks, unstable angina, stroke, or severe heart failure.My diabetes results in high blood sugar or A1C levels.You have symptoms that suggest low levels of male hormones, as determined by a questionnaire called the Androgen Deficiency in Aging Male (ADAM).My average morning testosterone levels are below 300 ng/dl.I am between 40 and 65 years old.I am a man with a BMI of 35 or higher.I am between 40 and 65 years old.You have symptoms that suggest a lack of male hormones (androgens), as determined by a questionnaire called ADAM.I am not taking drugs that affect hormone levels or bone health.My average morning testosterone levels are below 300 ng/dl.I have a condition affecting my pituitary or hypothalamus.I have severe sleep apnea that hasn't been treated.You have a history of heavy drinking or drug abuse.I need steroids or extra oxygen for my severe lung condition.Estradiol levels of ≥17 pg/ml.I have severe urinary or prostate problems with a high symptom score.I have had a deep vein thrombosis or pulmonary embolism.I have prostate cancer or my PSA level is above 4 ng/ml.I have had osteoporosis or a fracture from a minor injury.
Research Study Groups:
This trial has the following groups:- Group 1: Weight loss plus anastrozole
- Group 2: Weight loss plus placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
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