120 Participants Needed

Anastrozole for Obesity and Low Testosterone

DT
RV
Overseen ByReina Villareal, MD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Anastrozole has been studied for safety in humans, particularly in women with breast cancer. It generally has fewer gynecologic side effects compared to tamoxifen, another breast cancer treatment, according to the ATAC trial.12345

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

I am a man with a BMI of 35 or higher.
Luteinizing Hormone (LH) of <9.0 mIU/L
You have symptoms that suggest low levels of male hormones, as determined by a questionnaire called the Androgen Deficiency in Aging Male (ADAM).
See 9 more

Exclusion Criteria

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.
condition that could prevent from completing the study
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Anastrozole or placebo daily, along with a lifestyle intervention including diet and supervised exercise program

12 months
Weekly group behavior modification sessions for the first 3 months, then bi-weekly until 12 months; supervised exercise sessions for 6 months, then community-based sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Anastrozole
Trial Overview 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.
How Is the Trial Designed?
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.

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Arimidex for:
  • Breast cancer
  • Early breast cancer in postmenopausal women
🇺🇸
Approved in United States as Arimidex for:
  • 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
🇨🇦
Approved in Canada as Arimidex for:
  • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
  • Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
🇯🇵
Approved in Japan as Arimidex for:
  • Breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

Published Research Related to This Trial

In a study of 344 men, the combination of anastrozole and testosterone delivered via a subcutaneous implant effectively maintained low estradiol levels, preventing side effects associated with excess estrogen during testosterone therapy.
The therapy allowed for higher testosterone dosing and longer intervals between implant insertions, with no reported adverse events, indicating a safe and effective approach to managing hormone levels.
Subcutaneous Testosterone Anastrozole Therapy in Men: Rationale, Dosing, and Levels on Therapy.Glaser, RL., York, AE.[2019]
Anastrozole is more effective than tamoxifen in improving disease-free survival and reducing tumor recurrence in postmenopausal women with hormone receptor-positive early breast cancer, as shown in the ATAC trial with significant relative risk reductions of 17% and 19%.
Anastrozole has a better safety profile compared to tamoxifen, with lower rates of side effects such as vaginal bleeding, hot flushes, and thromboembolic events, while both treatments had similar impacts on patient quality of life during the first two years.
Anastrozole: in early breast cancer.Wellington, K., Faulds, DM.[2018]
After 5 years of treatment with anastrozole, patients showed a significant increase in lumbar spine bone mineral density (BMD), with increases of 2.35% and 4.02% at years 6 and 7, respectively, indicating a positive effect on bone health.
In contrast, tamoxifen treatment resulted in a decrease in lumbar spine and total hip BMD, suggesting that anastrozole may be a safer option for maintaining bone density in patients compared to tamoxifen.
Long-term effects of anastrozole on bone mineral density: 7-year results from the ATAC trial.Eastell, R., Adams, J., Clack, G., et al.[2022]

Citations

Subcutaneous Testosterone Anastrozole Therapy in Men: Rationale, Dosing, and Levels on Therapy. [2019]
Anastrozole: in early breast cancer. [2018]
Long-term effects of anastrozole on bone mineral density: 7-year results from the ATAC trial. [2022]
Effect of anastrozole on bone mineral density: 5-year results from the anastrozole, tamoxifen, alone or in combination trial 18233230. [2022]
Efficacy of Anastrozole in a Consecutive Series of Advanced Breast Cancer Patients Treated with Multiple Prior Chemotherapies and Endocrine Agents: M. D. Anderson Cancer Center Experience. [2019]
Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. [2022]
A lower incidence of gynecologic adverse events and interventions with anastrozole than with tamoxifen in the ATAC trial. [2018]
Phase II trial of anastrozole in women with asymptomatic müllerian cancer. [2019]
The effects of anastrozole on the proliferation of FM3A cells. [2018]
[Clinical study of anastrozole in the treatment of postmenopausal women with advanced breast cancer]. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Does obesity interfere with anastrozole treatment? Positive association between body mass index and anastrozole plasma levels. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Safety and efficacy of anastrozole for the treatment of pubertal gynecomastia: a randomized, double-blind, placebo-controlled trial. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC trial. [2022]
Pharmacological and clinical profile of anastrozole. [2019]
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