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Anastrozole for Obesity and Low Testosterone
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Weight loss plus anastrozole
- Group 2: Weight loss plus placebo
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Is this scientific inquiry currently seeking participants?
"Affirmative. Evident from the clinicaltrials.gov website, this medical investigation is currently searching for volunteers to participate in its study. It was first reported on April 15th 2018 and most recently revised on January 19th 2022; it aims to include 120 people at one location."
How many participants are partaking in this experiment?
"Affirmative, current records on clinicaltrials.gov declare that this study is actively seeking participants. The trial was first advertised in April of 2018 and has since been updated at the start of January 2022; inviting 120 patients to be enrolled from a single medical centre."
Are those under the age of 75 eligible to participate in this research?
"This particular trial only allows individuals between the ages of 40 to 65 to partake. Nevertheless, other clinical trials are available for those below 18 and above 65; with 215 studies targeting minors and 775 aimed at senior citizens respectively."
Has the United States Food and Drug Administration sanctioned a one milligram daily dosage of anastrozole?
"As this is a Phase 4 trial, indicating that anastrozole (1 mg/day) has already been approved, our team gave it the highest possible safety rating of 3."
What conditions does 1 mg/day of anastrozole most commonly provide relief to?
"Anastrozole (1 mg/day) is commonly used to treat breast cancer, but can also yield positive results in the treatment of malignant neoplasms, hormone receptor unknown tumors and be employed as an adjunct therapy following 2-3 years of tamoxifen use."
What other scientific investigatory projects have been conducted using a daily dosage of anastrozole (1 mg)?
"At this moment in time, 73 clinical trials are taking place with anastrozole (1 mg/day). 25 of these investigations have entered the third phase and there are 7812 sites conducting research for this drug. The bulk of studies for 1mg/day anastrozole take place in Pisa, PI."
Who meets the criteria to be eligible for participation in this clinical trial?
"This study aims to enroll 120 obese individuals aged 40-65 years with specific parameters. Criteria include a BMI of ≥35 kg/m2, testosterone levels <300 ng/dl (as determined by two readings taken between 8-10 AM on 2 separate days), LH <9.0 mIU/L and Estradiol ≥17 pg/ml in addition to symptoms consistent with Androgen Deficiency as assessed via the ADAM questionnaire."
What are the primary goals of this clinical experiment?
"This clinical trial will span 12 months, with the primary outcome being an evaluation of Hormonal Profile Changes. Other gonadal hormone levels, metabolic risk factors (assessed via Homeostasis Model Assessment for Insulin Resistance [HOMA-IR]), and changes in bone markers (measured by serum procollagen 1 Intact N-terminal) are all considered secondary outcomes."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
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Most responsive sites:
- Michael E. DeBakey VAMC: < 48 hours
Average response time
- < 2 Days
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