Using aromatase inhibitors to aid weight loss in obese men with low testosterone
Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism
This study is testing if a medication called anastrozole can help severely obese men with low testosterone lose weight and improve their hormone levels.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Male |
| Sponsor | Baylor College of Medicine Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03490513 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of the aromatase inhibitor anastrozole on weight loss and testosterone levels in severely obese men aged 40 to 65 with hypogonadotropic hypogonadism. The study aims to determine if reducing estrogen levels through aromatase inhibition can improve testosterone production and alleviate symptoms associated with low testosterone. Participants will receive either anastrozole or a placebo while their hormone levels and weight changes are monitored. The trial seeks to address the challenges faced by obese men who experience minimal benefits from traditional testosterone therapy due to high estrogen levels.
Who should consider this trial
Good fit: Ideal candidates are obese men aged 40 to 65 with a BMI of 35 kg/m2 or higher and low testosterone levels.
Not a fit: Patients with pituitary or hypothalamic diseases, or those on medications affecting hormone levels, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve testosterone levels and overall quality of life for obese men suffering from hypogonadism.
How similar studies have performed: While the use of aromatase inhibitors in this context is novel, previous studies have shown that weight loss can positively impact testosterone levels in obese men.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * obese men with body mass index (BMI) of ≥35 kg/m2 * age between 40 to 65 years old * average fasting testosterone level from 2 measurements taken between 8 to 10 AM on 2 separate days of \<300 ng/dl * Luteinizing Hormone (LH) of \<9.0 mIU/L * Estradiol of ≥17 pg/ml * Symptoms consistent with androgen deficiency as assessed by Androgen Deficiency in Aging Male (ADAM) questionnaire Exclusion criteria: * pituitary or hypothalamic disease, * drugs affecting gonadal hormone levels, production and action or bone metabolism (bisphosphonates, teriparatide, denosumab, glucocorticoids, phenytoin) * diseases affecting bone metabolism (e.g. hyperparathyroidism, untreated hyperthyroidism, osteomalacia, chronic liver disease, significant renal failure, hypercortisolism, malabsorption, immobilization, Paget's disease), * prostate carcinoma or elevated serum prostate specific antigen (PSA)\> 4 ng/ml, * Hematocrit \> 50%, * untreated severe obstructive sleep apnea, * Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease (e.g., New York Heart Association Class III or IV congestive heart failure * severe pulmonary disease requiring steroid pills or the use of supplemental oxygen (that would contraindicate exercise or dietary restriction) * History of deep vein thrombosis or pulmonary embolism * severe lower urinary tract or prostate symptoms with International Prostate Symptom Score (IPSS) above 19 * excessive alcohol or substance abuse * unstable weight (i.e. \>±2 kg) in the last 3 months * condition that could prevent from completing the study * screening bone mineral density (BMD) T-score of \<-2.0 at the spine, femoral neck or total femur * history of osteoporosis or fragility fracture * Diabetes mellitus with a fasting blood glucose of \>140 mg/dl, and/or Hemoglobin A1C (A1C) \>8.5%.
Where this trial is running
Houston, Texas
- Michael E. DeBakey VAMC — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Reina Villareal, MD
- Email: reina.villareal@bcm.edu
- Phone: 1737947534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.