Anastrozole for Obesity and Low Testosterone
What You Need to Know Before You Apply
What is the purpose of this trial?
The investigators have preliminary data suggesting that obese patients with hypogonadotropic hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased conversion of androgens into estrogens in obese men results in a negative feedback of high estradiol levels on hypothalamus and pituitary, inhibiting the production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH) and, as a consequence, of testosterone by the testis. Testosterone administration could increase estradiol production, further promoting the inhibitory feedback to the hypothalamic-pituitary-gonadal axis. Although weight loss from lifestyle modification has been shown to reduce estradiol and increase testosterone levels, the effect is at best modest and weight regain results in recurrence of hypogonadism. The use of aromatase inhibitors, in combination with weight loss, could be an effective alternative strategy due to its action at the pathophysiology of the disease.Intervention Subjects (body mass index of ≥35, testosterone \<300 ng/dl) will be randomized to the active (anastrozole) or control (placebo) group. Anastrozole 1 mg tablet / day will be self-administered with or without food, at around the same time every day (active group); placebo 1 tablet/day with or without food to take at around the same time every day (control group). The study duration will be 12 months.Both groups will undergo lifestyle intervention consisting of diet and supervised exercise program. Target weight loss will be at least 10% of baseline body weight during the intervention. Subjects will attend weekly group behavior modification sessions which will last \~75-90 min for the first 3 months and decreased to every two weeks from 3 to 12 months. Subjects will attend supervised research center-based exercise sessions during the first 6 months followed by community fitness center-based sessions during the next 6 months for at least 2 d/wk, with recording of home-based exercises for the other 2-4 days/week.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that affect hormone levels or bone metabolism.
Is anastrozole safe for humans?
How does the drug anastrozole differ from other treatments for obesity and low testosterone?
Anastrozole is unique because it is an aromatase inhibitor that reduces estrogen levels, which can help increase testosterone levels. This is different from other treatments that might directly supplement testosterone without addressing estrogen levels, potentially leading to fewer side effects related to excess estrogen.678910
What data supports the effectiveness of the drug Anastrozole for obesity and low testosterone?
Anastrozole, when combined with testosterone therapy, has been shown to maintain low levels of estradiol (a form of estrogen) in men, which can help prevent side effects associated with excess estrogen during testosterone treatment. This suggests it may be effective in managing hormone levels, which could be relevant for conditions like low testosterone.711121314
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either Anastrozole or placebo daily, along with a lifestyle intervention including diet and supervised exercise program
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anastrozole
Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:
- Breast cancer
- Early breast cancer in postmenopausal women
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor