A Phase 4 interventional study of anastrozole (1 mg/day) and Placebo in Hypogonadism, Hypogonadotropic and Obesity, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to male participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Baylor College of Medicine · Phase 4, Interventional, and Treatment
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.
Although the above original protocol requires the participants to come to our center for dietary and exercise training, since the Covid19 pandemic, study participants were given the following options for lifestyle intervention: 1) in-person visits at our facility for dietary classes and exercise training, 2) to enlist in the gym of their choice with membership paid for by the study, or 3) virtual method of lifestyle intervention. These amendments were put in place due to Covid 19 restrictions; however, we decided to keep these methods because most of our subjects prefer them over coming for in-person visits at our lab even after COVID restrictions were lifted. Since the study had just the first 25 subjects enrolled prior to COVID outbreak, majority of the subject's lifestyle interventions were done by virtual dietary classes every week for the first 3 months and then every 2 weeks thereafter either as a group or by one-on-one sessions. Exercise program was also supervised by exercise physiologist virtually or by phone for subjects who want to exercise at a community gym
After age of 40, testosterone (T) production in men gradually decreases at a rate of 1.6% per year for total and to 2-3% per year for bioavailable T. This reduction in T production in men parallels the age-associated loss of muscle mass that leads to sarcopenia and impairment of function and the age-associated loss of bone mass that leads to osteopenia and fracture risk.
Hypogonadism is a condition associated with multiple symptom complex including fatigue, depressed mood, osteoporosis, gain of fat mass, loss of libido and reduced muscle strength, all of which deeply affect patient quality of life. The prevalence of hypogonadism among obese men was estimated to be as much as 40% and could as much as 50% if they are also diabetic, with levels of androgens decreasing proportionately to the degree of obesity.
In obese men, the age-related decline in T is exacerbated by the suppression of the hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase enzyme in the adipose tissue enhances the conversion of androgens into estrogens which in turn exerts a negative feedback 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 T by the testis resulting in hypogonadotropic hypogonadism (HH). Considering the high aromatase expression in the adipose tissue, the administration of T among obese men with HHG could increase the conversion of the substrate T to estradiol (E2) and fuels the negative feedback on hypothalamus and pituitary, producing a greater suppression of GnRH and gonadotropins. Thus, men with obesity induced HHG may benefit from other treatment strategies that target the pathophysiology of the disease.
Although weight loss intervention improves hormonal and metabolic abnormalities related to obesity, the increase in T levels induced by weight loss are often lost due to weight regain, which is very frequent among patients undergoing massive weight loss. One possible approach is the use of aromatase inhibitors (AI) to stop the conversion of T to E2 thereby interrupting the vicious cycle of E2 inhibition of the hypothalamic-pituitary-gonadal axis and restoring T production to normal levels. Since weight loss remains the standard of care for obese patients, the investigators propose the following OBJECTIVES:
As secondary aim, the investigators will elucidate the mechanism for the anticipated positive effects of AI+WL on obesity-associated HHG.
This is a randomized double-blind placebo-controlled study comparing the effect of weight loss + anastrozole to weight loss + placebo for 12 months on the hormonal profile and symptoms associated with hypogonadism in severely obese men with a body mass index (BMI) of more or equal to 35 kg/m2.
320 studies on the registry are indexed under Hypogonadism; 39 are open to participants now.
This study's enrollment of 121 is above the median of 50 across 243 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will take a placebo every day
Drug: Placebo
Participants will take Anastrozole 1mg per day
Drug: anastrozole (1 mg/day)
Drug page: Anastrozole
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 participate in a supervised exercise training program.
Also known as: Weight loss
Participants will take a placebo tablet every day, attend behavioral classes conducted by a dietitian, receive instruction on how to loss 10% of their body weight and participate in a supervised exercise training program.
Also known as: Weight loss
Change in Serum Testosterone From Baseline to 12 Months
Change in serum testosterone levels from baseline to 12 months. An increase in testosterone levels suggests in improvement in hormonal profile in men with hypogonadism or low testosterone.
Time frame: 12 months
Percent Change in Muscle Strength From Baseline to 12 Months
Percent change in muscle strength (in Newton-meters) as assessed by knee extension strength using a Biodex machine from baseline to 12 months. An increase in knee extension indicates an improvement in muscle strength of the lower extremity.
Time frame: 12 months
Percent Change in Total Lean Mass From Baseline to 12 Months.
Percent change in total lean mass (in kilograms) as measured by dual energy x-ray absorptiometry from baseline to 12 months. An increase in lean mass suggests an increase in muscle mass while a reduction implies the opposite.
Time frame: 12 months
Percent Change in Total Hip Areal Bone Mineral Density From Baseline to 12 Months.
Precent change in total hip areal bone mineral density (aBMD) in g/cm2 as assessed by dual energy absorptiometry of the proximal left femur (right if left had surgery) from baseline to 12 months. An increase in hip aBMD indicates improvement in hip bone mass while a reduction suggests the opposite.
Time frame: 12 months
Change in Estradiol From Baseline to 12 Months.
Change in serum estradiol levels from baseline to 12 months. Men with obesity have high estradiol levels due to increase conversion of testosterone to estradiol in the abundant fat tissues. A reduction in estradiol in men with obesity from weight loss, with or without anastrozole, suggests an improvement in hormonal profile.
Time frame: 12 months
Change in Luteinizing Hormone Levels From Baseline to 12 Months.
Change in serum luteinizing hormone (LH) levels from baseline to 12 months. In men with obesity, LH level is suppressed due to high estradiol level. An increase in LH from weight loss, with or without anastrozole, indicates improvement in hormonal profile.
Time frame: 12 months
Change in Follicle Stimulating Hormone Levels From Baseline to 12 Months
Change in serum follicle stimulating hormone (FSH) from baseline to 12 months. In men with obesity, FSH level is suppressed due to high estradiol level. An increase in FSH from weight loss, with or without anastrozole, indicates improvement in hormonal profile.
Time frame: 12 months
Changes in Thigh Muscle Volume
Assessed magnetic resonance imaging of both thighs.
Time frame: 12 months
Percent Change in Symptoms of Hypogonadism Using the Androgen Deficiency in Aging Male (ADAM) Questionnaire From Baseline to 12 Months.
Percent change in symptoms of hypogonadism from baseline to 12 months as assessed by the quantitative Androgen Deficiency in Aging Male (qADAM) questionnaire; higher scores indicate better outcome. Minimum score is 10 (poorest, i.e. most symptomatic) and the highest score is 50 (excellent, i.e. least symptomatic). Percent changes in scores from baseline to 12 months were calculated. An increase in scores from baseline indicates improvement in symptoms of low testosterone or hypogonadism.
Time frame: 12 months
Changes in Symptoms of Hypogonadism Using International Index of Erectile Function (IIEF) Questionnaire
Assessed by the International Index of Erectile Function (IIEF) questionnaire; higher scores indicating better outcome. Minimum score is 0 (poorest or most symptomatic) and maximum score is 75 (excellent or least symptomatic). Percent change in scores from baseline to 12 months were calculated. An increase in scores from baseline indicates an improvement in erectile symptoms.
Time frame: 12 months
Changes in Symptoms of Hypogonadism and Obesity
Evaluated by the Impact of Weight on Quality of Life questionnaire which assesses weight-related quality of life and include 5 domains as: Physical Function (11 items), Self-Esteem (7 items), Sexual Life (4 items), Public Distress (5 items), Work (4 items)
Time frame: 12 months
Percent Change in Visceral Adipose Tissue Volume From Baseline to 12 Months.
Percent change in visceral adipose tissue (VAT) volume (in cubic centimeter) measured by dual energy X-ray absorptiometry from baseline to 12 months. High VAT volume is associated with increased metabolic dysfunction and inflammation. A reduction in VAT from weight loss is usually associated with improvement in metabolic and inflammatory profile.
Time frame: 12 months
Percent Change in Hemoglobin A1C From Baseline to 12 Months.
Percent change in hemoglobin A1C (A1C, unit in %)) in the blood from baseline to 12 months. A reduction in A1C indicates an improvement in glucometabolic homeostasis.
Time frame: 12 months
Percent Change in Low Density Cholesterol Levels From Baseline to 12 Months.
Percent change in serum low density cholesterol (LDL, unit in mg/dl) levels from baseline to 12 months. A reduction in LDL cholesterol indicates in improvement lipid metabolism.
Time frame: 12 months
Percent Change in Homeostatic Model Assessment for Insulin Resistance From Baseline to 12 Months.
Percent change in serum homeostatic model assessment for insulin resistance (HOMA-IR, unitless as it is an index) calculated as (insulin \[microU/L\] x glucose \[mg/dl\])/405, from baseline to 12 months. A reduction in HOMA-IR indicates improvement in insulin resistance.
Time frame: 12 months
Percent Change in Total Volumetric Bone Density of the Radius
Percent change in total volumetric bone mineral density (vBMD, unit in milligrams per cubic centimeter) of the radius by high-resolution peripheral quantitative computer tomography from baseline to 12 months. An increase in vBMD indicates bone gain while a reduction suggests bone loss.
Time frame: 12 months
Percent Change in Failure Load at the Radius From Baseline to 12 Months,
Percent change in failure load (unit in kilo-Newtons or Kn), a measure of bone strength, assessed by high-resolution peripheral quantitative computer tomography of the radius from baseline to 12 months. An increase in failure load indicates increase in bone strength while the reduction suggests the opposite
Time frame: 12 months
Percent Change in C-terminal Telopeptide of Type I Collagen (CTX)
Percent change in serum C-terminal telopeptide of type I collagen (CTX) (unit in ng/ml), a marker of bone resorption, from baseline to 12 months. An increase in CTX indicates increased bone resorption which contributes to bone loss, while a reduction suggests decreased bone resorption.
Time frame: 12 months
Percent Change in Osteocalcin From Baseline to 12 Months.
Percent change in serum osteocalcin (unit in ng/ml), a marker of bone formation, from baseline to 12 months. An increase in osteocalcin suggests an increase in bone formation.
Time frame: 12 months
Percent Change in Procollagen Type 1 N-terminal Propeptide (P1NP) From Baseline to 12 Months
Percent change in serum N-terminal propeptide (P1NP) (unit in ng/ml), a marker of bone formation, from baseline to 12 months. An increase in P1NP suggests an increase in bone formation.
Time frame: 12 months
Participants were recruited by letters, and flyers, and from referrals from the different clinics (mainly Primary Care, and Endocrine Clinics) at the Michael E. DeBakey VA Medical Center from May 1, 2018 to June 30, 2024.
| Milestone | Placebo N=60 | Anastrozole N=61 |
|---|---|---|
| Started | 60 | 61 |
| Completed | 39 | 48 |
| Not completed | 21 | 13 |
Change in serum testosterone levels from baseline to 12 months. An increase in testosterone levels suggests in improvement in hormonal profile in men with hypogonadism or low testosterone.
| change in ng/dl from baseline | Anastrozole | Placebo |
|---|---|---|
| Change in Serum Testosterone From Baseline to 12 Months | 137.7 ± 120.0 | 38.6 ± 85.2 |
Percent change in muscle strength (in Newton-meters) as assessed by knee extension strength using a Biodex machine from baseline to 12 months. An increase in knee extension indicates an improvement in muscle strength of the lower extremity.
| % change from baseline to 12 months | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Muscle Strength From Baseline to 12 Months | 9.14 ± 23.9 | 15.1 ± 43.8 |
Percent change in total lean mass (in kilograms) as measured by dual energy x-ray absorptiometry from baseline to 12 months. An increase in lean mass suggests an increase in muscle mass while a reduction implies the opposite.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Total Lean Mass From Baseline to 12 Months. | -1.0 ± 3.7 | -2.1 ± 4.4 |
Precent change in total hip areal bone mineral density (aBMD) in g/cm2 as assessed by dual energy absorptiometry of the proximal left femur (right if left had surgery) from baseline to 12 months. An increase in hip aBMD indicates improvement in hip bone mass while a reduction suggests the opposite.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Total Hip Areal Bone Mineral Density From Baseline to 12 Months. | -0.08 ± 4.6 | 0.98 ± 4.9 |
Change in serum estradiol levels from baseline to 12 months. Men with obesity have high estradiol levels due to increase conversion of testosterone to estradiol in the abundant fat tissues. A reduction in estradiol in men with obesity from weight loss, with or without anastrozole, suggests an improvement in hormonal profile.
| change in pg/ml from baseline | Anastrozole | Placebo |
|---|---|---|
| Change in Estradiol From Baseline to 12 Months. | -13.1 ± 13.7 | -1.43 ± 8.22 |
Change in serum luteinizing hormone (LH) levels from baseline to 12 months. In men with obesity, LH level is suppressed due to high estradiol level. An increase in LH from weight loss, with or without anastrozole, indicates improvement in hormonal profile.
| Change in mIU/ml from baseline | Anastrozole | Placebo |
|---|---|---|
| Change in Luteinizing Hormone Levels From Baseline to 12 Months. | 2.06 ± 4.67 | 0.39 ± 1.78 |
Change in serum follicle stimulating hormone (FSH) from baseline to 12 months. In men with obesity, FSH level is suppressed due to high estradiol level. An increase in FSH from weight loss, with or without anastrozole, indicates improvement in hormonal profile.
| Change in mIU/ml from baseline | Anastrozole | Placebo |
|---|---|---|
| Change in Follicle Stimulating Hormone Levels From Baseline to 12 Months | 5.42 ± 6.81 | 0.44 ± 3.12 |
Assessed magnetic resonance imaging of both thighs.
Results for this outcome have not been posted.
Percent change in symptoms of hypogonadism from baseline to 12 months as assessed by the quantitative Androgen Deficiency in Aging Male (qADAM) questionnaire; higher scores indicate better outcome. Minimum score is 10 (poorest, i.e. most symptomatic) and the highest score is 50 (excellent, i.e. least symptomatic). Percent changes in scores from baseline to 12 months were calculated. An increase in scores from baseline indicates improvement in symptoms of low testosterone or hypogonadism.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Symptoms of Hypogonadism Using the Androgen Deficiency in Aging Male (ADAM) Questionnaire From Baseline to 12 Months. | 3.8 ± 22.1 | 21.5 ± 30.9 |
Assessed by the International Index of Erectile Function (IIEF) questionnaire; higher scores indicating better outcome. Minimum score is 0 (poorest or most symptomatic) and maximum score is 75 (excellent or least symptomatic). Percent change in scores from baseline to 12 months were calculated. An increase in scores from baseline indicates an improvement in erectile symptoms.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Changes in Symptoms of Hypogonadism Using International Index of Erectile Function (IIEF) Questionnaire | 2.1 ± 31.4 | 31.5 ± 85.1 |
Evaluated by the Impact of Weight on Quality of Life questionnaire which assesses weight-related quality of life and include 5 domains as: Physical Function (11 items), Self-Esteem (7 items), Sexual Life (4 items), Public Distress (5 items), Work (4 items)
Results for this outcome have not been posted.
Percent change in visceral adipose tissue (VAT) volume (in cubic centimeter) measured by dual energy X-ray absorptiometry from baseline to 12 months. High VAT volume is associated with increased metabolic dysfunction and inflammation. A reduction in VAT from weight loss is usually associated with improvement in metabolic and inflammatory profile.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Visceral Adipose Tissue Volume From Baseline to 12 Months. | -3.8 ± 27.7 | -6.1 ± 33.1 |
Percent change in hemoglobin A1C (A1C, unit in %)) in the blood from baseline to 12 months. A reduction in A1C indicates an improvement in glucometabolic homeostasis.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Hemoglobin A1C From Baseline to 12 Months. | 1.67 ± 14.5 | -2.58 ± 23.4 |
Percent change in serum low density cholesterol (LDL, unit in mg/dl) levels from baseline to 12 months. A reduction in LDL cholesterol indicates in improvement lipid metabolism.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Low Density Cholesterol Levels From Baseline to 12 Months. | -2.77 ± 21.7 | 10.87 ± 56.60 |
Percent change in serum homeostatic model assessment for insulin resistance (HOMA-IR, unitless as it is an index) calculated as (insulin \[microU/L\] x glucose \[mg/dl\])/405, from baseline to 12 months. A reduction in HOMA-IR indicates improvement in insulin resistance.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Homeostatic Model Assessment for Insulin Resistance From Baseline to 12 Months. | 28.3 ± 137.4 | 23.9 ± 93.7 |
Percent change in total volumetric bone mineral density (vBMD, unit in milligrams per cubic centimeter) of the radius by high-resolution peripheral quantitative computer tomography from baseline to 12 months. An increase in vBMD indicates bone gain while a reduction suggests bone loss.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Total Volumetric Bone Density of the Radius | 1.40 ± 9.5 | 0.03 ± 9.0 |
Percent change in failure load (unit in kilo-Newtons or Kn), a measure of bone strength, assessed by high-resolution peripheral quantitative computer tomography of the radius from baseline to 12 months. An increase in failure load indicates increase in bone strength while the reduction suggests the opposite
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Failure Load at the Radius From Baseline to 12 Months, | 0.27 ± 8.7 | 0.40 ± 7.3 |
Percent change in serum C-terminal telopeptide of type I collagen (CTX) (unit in ng/ml), a marker of bone resorption, from baseline to 12 months. An increase in CTX indicates increased bone resorption which contributes to bone loss, while a reduction suggests decreased bone resorption.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in C-terminal Telopeptide of Type I Collagen (CTX) | -19.9 ± 84.6 | -28.9 ± 96.2 |
Percent change in serum osteocalcin (unit in ng/ml), a marker of bone formation, from baseline to 12 months. An increase in osteocalcin suggests an increase in bone formation.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Osteocalcin From Baseline to 12 Months. | -4.21 ± 175 | 34.16 ± 217.7 |
Percent change in serum N-terminal propeptide (P1NP) (unit in ng/ml), a marker of bone formation, from baseline to 12 months. An increase in P1NP suggests an increase in bone formation.
| % change from baseline | Anastrozole | Placebo |
|---|---|---|
| Percent Change in Procollagen Type 1 N-terminal Propeptide (P1NP) From Baseline to 12 Months | 23.71 ± 84.8 | 31.73 ± 172.7 |
Collected over 7 years and 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anastrozole | 0/61 (0%) | 4/61 (6.6%) | 14/61 (23%) |
| Placebo | 0/60 (0%) | 1/60 (1.7%) | 10/60 (16.7%) |
| Event | Anastrozole | Placebo |
|---|---|---|
| admitted for continuous electroencephalogram (EEG) studiesNervous system disorders | 0/61 | 1/60 |
| Cardiac arrhythmiaCardiac disorders | 1/61 | 0/60 |
| hemorrhoid infectionGastrointestinal disorders | 1/61 | 0/60 |
| COVID-19 infectionInfections and infestations | 1/61 | 0/60 |
| complication from cataract ssurgeryEye disorders | 1/61 | 0/60 |
| Event | Anastrozole | Placebo |
|---|---|---|
| back pain, foot pain, shoulder pain and knee joint painMusculoskeletal and connective tissue disorders | 6/61 | 5/60 |
| chest painCardiac disorders | 2/61 | 0/60 |
| hemorrhoid infectionGastrointestinal disorders | 2/61 | 0/60 |
| diarrheaGastrointestinal disorders | 0/61 | 1/60 |
| kidney stonesRenal and urinary disorders | 0/61 | 1/60 |
| dehydrationVascular disorders | 0/61 | 1/60 |
| sciaticaNervous system disorders | 0/61 | 1/60 |
| hair lossSkin and subcutaneous tissue disorders | 0/61 | 1/60 |
| vasectomy operationRenal and urinary disorders | 1/61 | 0/60 |
| ear surgeryEar and labyrinth disorders | 1/61 | 0/60 |
| Age, Categorical(Participants) | Anastrozole | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 61 | 60 | 121 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Anastrozole | Placebo | Total |
|---|---|---|---|
| Mean | 50.7 ± 7.2 | 51.6 ± 7.9 | 51.2 ± 7.5 |
| Sex: Female, Male(Participants) | Anastrozole | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 61 | 60 | 121 |
| Race (NIH/OMB)(Participants) | Anastrozole | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 25 | 30 | 55 |
| White | 34 | 29 | 63 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Anastrozole | Placebo | Total |
|---|---|---|---|
| United States | 61 | 60 | 121 |
| Testosterone level(ng/dl) | Anastrozole | Placebo | Total |
|---|---|---|---|
| Mean | 228.0 ± 50.7 | 232.1 ± 54.8 | 230 ± 52.6 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Anastrozole