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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

Pivotal Trial

Drug Has Already Been Approved

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 below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

This trial's timeline: 2 days for screening, 12 months for treatment, and 1 day for reporting.

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 more

Secondary study objectives

Changes in bone markers

Changes in bone quality

Changes in metabolic risk factors

+6 more

Awards & Highlights

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.

Trial 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.

0 / 15Eligibility criteria met