Hypogonadism, Pain
Conditions
Keywords
Testosterone, Pain, Opioid, Hypogonadism
Brief summary
Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for pain control have decreased serum testosterone levels. Indeed, these men complain of decreased libido, erectile dysfunction and impaired quality of life. Animal studies have shown that gonadectomy results in a decrease in pain threshold in rats and repletion of testosterone elevates that threshold. These observations suggest that testosterone may possess analgesic properties. Hence, the investigators hypothesize that hypogonadism developing in men on opioids results in an increased sensitivity to pain and requirement of higher doses of opioids. In this study, the investigators plan to administer testosterone to men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in response to noxious stimuli and changes in the requirement of opioids in response to testosterone administration. Hypothesis: Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance, pain perception and quality of life. Specific aims: 1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance, and pain modulation in men with opioid-induced hypogonadism. 2. To determine the effects of testosterone replacement on health-related quality of life. 3. To determine whether testosterone replacement in hypogonadal men induces changes in the dosage requirements of opioid medications for pain control. To accomplish our specific aims, the investigators propose a randomized, double blind, placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back pain syndrome on chronic opioids and low testosterone levels (\<300 ng/dl) will be randomized to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in pain tolerance using various external painful stimuli. Secondary outcomes are change in pain sensitivity and modulation, quality of life and opioid requirements.
Interventions
DRUGAndroGel
5g gel, applied once daily to the upper arms, upper back or shoulders.
OTHERPlacebo
5g gel, applied once daily to the upper arms, upper back or shoulders.
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Men * Age 18 years and older * Non-cancer chronic pain * Serum total testosterone level \<350 ng/dl * Consumption of at least 20 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks * Absence of hospitalization in the past 2 months * No acute illness in the past 2 months * No current anabolic therapy (growth hormone, DHEA, etc) * No current use or consumption in the past 2 months of melatonin * Normal prostate exam * Normal PSA level
Exclusion criteria
* Cancer-related chronic pain * Liver enzymes \> 3 times upper limit of normal * Serum creatinine \> 2 times upper limit of normal * Neurological disease * Active psychiatric illness * Any addictive drug use * Alcoholism (\>3 drinks/day) * Patients currently receiving melatonin or anabolic agents * Hospitalization in the past 2 months * Acute illness in the past 2 months * Consumption of \< 20 mg of hydrocodone (or analgesic equivalent of another opioid) * Severe BPH * PSA \> 4.0 ng/ml * Prostate cancer * Breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ice Water-induced Cold Pain and Its After-sensation at Week 14 | Week 14 after intervention | Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain. |
| Brief Pain Inventory (BPI) at Week 14 | Week14 after intervention | BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain). |
| Algometer-induced Pressure Pain at Week 14 | Week 14 after intervention | A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain. |
| Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14 | Week 14 after intervention | Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Week 14 after intervention | The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL. |
| Pain Catastrophizing Scale (PCS) at Week 14 | Values at week 14 after intervention | PCS questionnaire measures self-assessment of pain catastrophizing. This questionnaire consists of 13 items on past painful experiences and rate on 5-point scales ranging from 0 (not at all) to 4 (all the time). The PCS yields three subscale scores assessing rumination (range 0-16), magnification (range 0-12), helplessness (range 0-24), and a composite score (sum of three domains, ranging 0-52). Higher score represents worse painful experiences. |
| Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Week14 after intervention | IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function. |
Other
| Measure | Time frame | Description |
|---|---|---|
| HbA1c at Week 14 | Week 14 after intervention | — |
| Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | Week 14 after intervention | All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The plasma glucose level were analyzed at baseline and at 60 and 120 min after glucose loading. |
| C-reactive Protein (CRP) at Week 14 | Week 14 after intervention | High-sensitivity C-reactive protein (Alpco Diagnostics) was measured using a high-sensitivity sandwich ELISA with an intra-assay CV of 5.6% |
| Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | Values at week 14 after intervention | All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The insulin level were analyzed at baseline and at 60 and 120 min after glucose loading. |
| Total Testosterone Values at Week 14 | Week 14 after intervention | Total testosterone was measured in a CDC-certified laboratory using an LC-MS/MS method with a sensitivity of 2 ng/dL. |
| Adiponectin at Week 14 | Week 14 after intervention | Total adiponectin was measured using an RIA kit with an interassay CV of 6.9-9.3% and an intra-assay CV of 1.8-6.2% (Millipore). |
| Leptin at Week 14 | Week 14 after intervention | Leptin levels were measured using ELISA with an interassay CV of 2.6% to 6.2% and in intra-assay CV of 2.6% to 4.6% (Millipore, Billerica, MA, USA). |
| Insomnia Severity Index (ISI) at Week 14 | Week 14 after intervention | ISI is comprised of 7 items assesses a participant's perception of insomnia. Each item is rated on a 5-point scale from 0 (none) to 4 (very severe). Scores from the questions are summed to assign a total score ranging from 0 to 28, where higher score represents worse insomnia problem. |
| HOMA IR Score at Week 14 | Week 14 after intervention | Insulin resistance was calculated using the homeostatic model assessment (HOMA) index: glucose \* insulin / 22.5. |
| Free Testosterone Values at Week 14 | Week 14 after intervention | Free testosterone was calculated using a law of mass action equation. |
| Sex Hormone Binding Globulin (SHBG) at Week 14 | Week 14 after intervention | Sex hormone binding globulin was measured using immunofluorometric assays, with limits of quantification of 2.5 nmol/L. |
| Luteinizing Hormone Values at Week 14 | Week 14 after intervention | Luteinizing hormone was measured using immunofluorometric assays, with limits of quantification of 0.05 U/L. |
| Inflammatory Cytokines at Week 14 | Week 14 after intervention | The pathophysiology of pain is measured by the proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-Alpha). |
| Body Composition at Week 14 | Week 14 after intervention | Body composition was measured using dual-energy X-ray absorptiometry scan. |
| Lipid Profile at Week 14 | Week 14 after intervention | Serum total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol levels were measured by enzymatic assays and standardized to the CDC using the Lipid Research Clinic protocol. Low-density lipoprotein (LDL) cholesterol was calculated using the Friedewald equation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Androgel (Testosterone Gel) Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders. | 36 |
| Placebo Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders. | 29 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Elevated PSA | 1 | 1 |
| Overall Study | Enrolled in another trial | 0 | 1 |
| Overall Study | Incarcerated | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Non-compliance | 0 | 1 |
| Overall Study | Traumatic ankle fracture | 1 | 0 |
| Overall Study | Unprofessional behavior | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Total | Androgel (Testosterone Gel) | Placebo |
|---|---|---|---|
| Adiponectin | 4.7 ug/mL STANDARD_DEVIATION 2.3 | 4.9 ug/mL STANDARD_DEVIATION 2.7 | 4.5 ug/mL STANDARD_DEVIATION 1.7 |
| Age, Continuous | 49 years STANDARD_DEVIATION 8 | 48 years STANDARD_DEVIATION 9 | 50 years STANDARD_DEVIATION 6 |
| Algometer-induced pressure pain Thumb | 375 kPa/cm2 STANDARD_DEVIATION 155 | 369 kPa/cm2 STANDARD_DEVIATION 125 | 383 kPa/cm2 STANDARD_DEVIATION 185 |
| Algometer-induced pressure pain Trapezius | 347 kPa/cm2 STANDARD_DEVIATION 157 | 341 kPa/cm2 STANDARD_DEVIATION 116 | 353 kPa/cm2 STANDARD_DEVIATION 197 |
| Body composition measured by dual energy x-ray absorptiometry Appendicular fat mass | 11.8 kg STANDARD_DEVIATION 5 | 11.7 kg STANDARD_DEVIATION 4.9 | 11.9 kg STANDARD_DEVIATION 5.1 |
| Body composition measured by dual energy x-ray absorptiometry Appendicular lean mass | 27.9 kg STANDARD_DEVIATION 4.1 | 27.4 kg STANDARD_DEVIATION 4 | 28.6 kg STANDARD_DEVIATION 4.2 |
| Body composition measured by dual energy x-ray absorptiometry Appendicular total mass | 38.8 kg STANDARD_DEVIATION 7.4 | 38.3 kg STANDARD_DEVIATION 7.8 | 39.4 kg STANDARD_DEVIATION 7 |
| Body composition measured by dual energy x-ray absorptiometry Fat mass | 26.9 kg STANDARD_DEVIATION 9.5 | 27.0 kg STANDARD_DEVIATION 9.7 | 26.8 kg STANDARD_DEVIATION 9.5 |
| Body composition measured by dual energy x-ray absorptiometry Lean mass | 58.6 kg STANDARD_DEVIATION 7.5 | 57.4 kg STANDARD_DEVIATION 7.8 | 60.1 kg STANDARD_DEVIATION 6.9 |
| Body composition measured by dual energy x-ray absorptiometry Total mass | 85.5 kg STANDARD_DEVIATION 15 | 84.4 kg STANDARD_DEVIATION 16.1 | 86.8 kg STANDARD_DEVIATION 13.8 |
| Body Mass Index (BMI) | 32.6 kg/m2 STANDARD_DEVIATION 7.4 | 32.0 kg/m2 STANDARD_DEVIATION 7 | 33.4 kg/m2 STANDARD_DEVIATION 8 |
| Brief Pain Inventory (BPI) questionnaire Interference | 5.4 units on a scale STANDARD_DEVIATION 2.1 | 5.8 units on a scale STANDARD_DEVIATION 2.2 | 4.9 units on a scale STANDARD_DEVIATION 1.8 |
| Brief Pain Inventory (BPI) questionnaire Severity | 5.6 units on a scale STANDARD_DEVIATION 1.6 | 5.7 units on a scale STANDARD_DEVIATION 1.5 | 5.5 units on a scale STANDARD_DEVIATION 1.7 |
| Brief Pain Inventory (BPI) questionnaire Total | 11.0 units on a scale STANDARD_DEVIATION 3.2 | 11.5 units on a scale STANDARD_DEVIATION 3.2 | 10.4 units on a scale STANDARD_DEVIATION 3.1 |
| C-reactive protein | 2.9 mg/L STANDARD_DEVIATION 3 | 3.1 mg/L STANDARD_DEVIATION 3.5 | 2.7 mg/L STANDARD_DEVIATION 2.3 |
| Free testosterone | 43.9 pg/mL STANDARD_DEVIATION 21 | 44.1 pg/mL STANDARD_DEVIATION 22.6 | 43.6 pg/mL STANDARD_DEVIATION 19.3 |
| Glucose levels in OGTT Fasting glucose | 5.3 mmol/L STANDARD_DEVIATION 1.8 | 5.2 mmol/L STANDARD_DEVIATION 0.7 | 5.6 mmol/L STANDARD_DEVIATION 2.6 |
| Glucose levels in OGTT OGTT 1-h glucose | 8.2 mmol/L STANDARD_DEVIATION 2.8 | 8.4 mmol/L STANDARD_DEVIATION 2.9 | 8.0 mmol/L STANDARD_DEVIATION 2.8 |
| Glucose levels in OGTT OGTT 2-h glucose | 6.3 mmol/L STANDARD_DEVIATION 1.9 | 6.5 mmol/L STANDARD_DEVIATION 1.9 | 6.0 mmol/L STANDARD_DEVIATION 2 |
| HbA1c | 5.9 percentage of glycossylated hemoglobin STANDARD_DEVIATION 0.01 | 5.7 percentage of glycossylated hemoglobin STANDARD_DEVIATION 0.01 | 6.2 percentage of glycossylated hemoglobin STANDARD_DEVIATION 0.02 |
| Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36) Bodily pain | 56 units on a scale STANDARD_DEVIATION 16 | 56 units on a scale STANDARD_DEVIATION 15 | 55 units on a scale STANDARD_DEVIATION 17 |
| Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36) Emotional well-being | 60 units on a scale STANDARD_DEVIATION 16 | 60 units on a scale STANDARD_DEVIATION 16 | 59 units on a scale STANDARD_DEVIATION 17 |
| Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36) Energry/fatigue | 37 units on a scale STANDARD_DEVIATION 18 | 37 units on a scale STANDARD_DEVIATION 18 | 37 units on a scale STANDARD_DEVIATION 18 |
| Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36) General health perceptions | 52 units on a scale STANDARD_DEVIATION 14 | 54 units on a scale STANDARD_DEVIATION 14 | 51 units on a scale STANDARD_DEVIATION 14 |
| Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36) Physical functioning | 39 units on a scale STANDARD_DEVIATION 23 | 41 units on a scale STANDARD_DEVIATION 22 | 38 units on a scale STANDARD_DEVIATION 25 |
| Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36) Role limitations due to emotional problems | 39 units on a scale STANDARD_DEVIATION 44 | 39 units on a scale STANDARD_DEVIATION 45 | 40 units on a scale STANDARD_DEVIATION 45 |
| Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36) Role limitations due to physical health problems | 13 units on a scale STANDARD_DEVIATION 27 | 10 units on a scale STANDARD_DEVIATION 24 | 18 units on a scale STANDARD_DEVIATION 31 |
| Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36) Social functioning | 54 units on a scale STANDARD_DEVIATION 14 | 53 units on a scale STANDARD_DEVIATION 13 | 54 units on a scale STANDARD_DEVIATION 15 |
| Hematocrit | 43 % | 44 % | 43 % |
| Hemoglobin | 15 g/dL | 15 g/dL | 14 g/dL |
| HOMA IR | 2.6 HOMA IR score STANDARD_DEVIATION 4.2 | 2.1 HOMA IR score STANDARD_DEVIATION 2.1 | 3.3 HOMA IR score STANDARD_DEVIATION 5.8 |
| Ice water-induced cold pain and its after-sensation Cold pain after sensation: 30s | 15.4 seconds STANDARD_DEVIATION 18.5 | 16.7 seconds STANDARD_DEVIATION 19.2 | 13.8 seconds STANDARD_DEVIATION 18 |
| Ice water-induced cold pain and its after-sensation Cold pain tolerance | 46.1 seconds STANDARD_DEVIATION 42.7 | 40.1 seconds STANDARD_DEVIATION 33.4 | 53.3 seconds STANDARD_DEVIATION 51.3 |
| IL-6 | 2.7 pg/mL STANDARD_DEVIATION 2.8 | 2.6 pg/mL STANDARD_DEVIATION 2.8 | 2.8 pg/mL STANDARD_DEVIATION 2.9 |
| Insomnia severity index (ISI) | 11.8 units on a scale STANDARD_DEVIATION 4.5 | 11.9 units on a scale STANDARD_DEVIATION 4.7 | 11.6 units on a scale STANDARD_DEVIATION 4.4 |
| Insulin levels in OGTT Fasting insulin | 80 pmol/L STANDARD_DEVIATION 126 | 64 pmol/L STANDARD_DEVIATION 66 | 100 pmol/L STANDARD_DEVIATION 174 |
| Insulin levels in OGTT OGTT 1-h insulin | 351 pmol/L STANDARD_DEVIATION 317 | 300 pmol/L STANDARD_DEVIATION 306 | 416 pmol/L STANDARD_DEVIATION 325 |
| Insulin levels in OGTT OGTT 2-h insulin | 275 pmol/L STANDARD_DEVIATION 266 | 246 pmol/L STANDARD_DEVIATION 242 | 311 pmol/L STANDARD_DEVIATION 293 |
| Leptin | 17 ug/L STANDARD_DEVIATION 14 | 16 ug/L STANDARD_DEVIATION 12 | 18 ug/L STANDARD_DEVIATION 17 |
| Lipid profile HDL | 1.0 mmol/L STANDARD_DEVIATION 0.3 | 1.0 mmol/L STANDARD_DEVIATION 0.3 | 1.1 mmol/L STANDARD_DEVIATION 0.4 |
| Lipid profile LDL | 3.0 mmol/L STANDARD_DEVIATION 1 | 2.8 mmol/L STANDARD_DEVIATION 1 | 3.2 mmol/L STANDARD_DEVIATION 0.9 |
| Lipid profile Total cholesterol | 4.9 mmol/L STANDARD_DEVIATION 1.2 | 4.6 mmol/L STANDARD_DEVIATION 1.1 | 5.2 mmol/L STANDARD_DEVIATION 1.2 |
| Lipid profile Triglycerides | 2.0 mmol/L STANDARD_DEVIATION 1.4 | 2.0 mmol/L STANDARD_DEVIATION 1.6 | 2.0 mmol/L STANDARD_DEVIATION 1.2 |
| Luteinizing hormone | 3.2 U/L STANDARD_DEVIATION 2.2 | 2.8 U/L STANDARD_DEVIATION 1.9 | 3.8 U/L STANDARD_DEVIATION 2.4 |
| Opioid dose (morphine equivalent) | 97 mg STANDARD_DEVIATION 161 | 114 mg STANDARD_DEVIATION 176 | 76 mg STANDARD_DEVIATION 139 |
| Pain catastrophizing scale (PCS) Composite score | 27 units on a scale STANDARD_DEVIATION 11 | 26 units on a scale STANDARD_DEVIATION 11 | 27 units on a scale STANDARD_DEVIATION 11 |
| Pain catastrophizing scale (PCS) Helplessness score | 11.6 units on a scale STANDARD_DEVIATION 5.2 | 11.5 units on a scale STANDARD_DEVIATION 5.3 | 11.6 units on a scale STANDARD_DEVIATION 5.1 |
| Pain catastrophizing scale (PCS) Magnification score | 4.9 units on a scale STANDARD_DEVIATION 3.1 | 4.7 units on a scale STANDARD_DEVIATION 3.2 | 5.1 units on a scale STANDARD_DEVIATION 2.9 |
| Pain catastrophizing scale (PCS) Rumination score | 9.5 units on a scale STANDARD_DEVIATION 3.6 | 9.5 units on a scale STANDARD_DEVIATION 4 | 9.6 units on a scale STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 65 participants | 36 participants | 29 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 65 Participants | 36 Participants | 29 Participants |
| Sex hormone binding globulin | 38.6 nmol/L STANDARD_DEVIATION 25.2 | 39.3 nmol/L STANDARD_DEVIATION 31.4 | 37.7 nmol/L STANDARD_DEVIATION 14.5 |
| Sexual Function as assessed by International Index of Erectile Function (IIEF) Erectile function | 17.9 units on a scale STANDARD_DEVIATION 9.8 | 18.8 units on a scale STANDARD_DEVIATION 9.2 | 16.8 units on a scale STANDARD_DEVIATION 10.6 |
| Sexual Function as assessed by International Index of Erectile Function (IIEF) Intercourse satisfaction | 7.7 units on a scale STANDARD_DEVIATION 5.1 | 8.2 units on a scale STANDARD_DEVIATION 4.6 | 7.1 units on a scale STANDARD_DEVIATION 5.6 |
| Sexual Function as assessed by International Index of Erectile Function (IIEF) Orgasmic function | 6.3 units on a scale STANDARD_DEVIATION 3.6 | 6.5 units on a scale STANDARD_DEVIATION 3.5 | 6.1 units on a scale STANDARD_DEVIATION 3.6 |
| Sexual Function as assessed by International Index of Erectile Function (IIEF) Overall satisfaction | 4.9 units on a scale STANDARD_DEVIATION 2.7 | 4.9 units on a scale STANDARD_DEVIATION 2.5 | 5.0 units on a scale STANDARD_DEVIATION 2.9 |
| Sexual Function as assessed by International Index of Erectile Function (IIEF) Sexual desire | 5.8 units on a scale STANDARD_DEVIATION 2.3 | 5.5 units on a scale STANDARD_DEVIATION 2.5 | 6.2 units on a scale STANDARD_DEVIATION 2.1 |
| Sexual Function as assessed by International Index of Erectile Function (IIEF) Total score | 43.0 units on a scale STANDARD_DEVIATION 20.2 | 44.6 units on a scale STANDARD_DEVIATION 19 | 41.1 units on a scale STANDARD_DEVIATION 21.7 |
| Time on opioids | 48 months STANDARD_DEVIATION 50 | 54 months STANDARD_DEVIATION 48 | 40 months STANDARD_DEVIATION 54 |
| TNF-Alpha | 2.0 pg/mL STANDARD_DEVIATION 1.9 | 1.8 pg/mL STANDARD_DEVIATION 0.6 | 2.2 pg/mL STANDARD_DEVIATION 2.7 |
| Total testosterone | 228 ng/dL STANDARD_DEVIATION 91 | 221 ng/dL STANDARD_DEVIATION 87 | 237 ng/dL STANDARD_DEVIATION 97 |
| Weighted pinprick stimulator-induced mechanical pain 10th stimulus | 23.2 watt STANDARD_DEVIATION 20.4 | 27.0 watt STANDARD_DEVIATION 20.6 | 18.6 watt STANDARD_DEVIATION 19.5 |
| Weighted pinprick stimulator-induced mechanical pain First stimulus | 10.2 watt STANDARD_DEVIATION 11 | 12.0 watt STANDARD_DEVIATION 13 | 8.0 watt STANDARD_DEVIATION 7.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 43 | 5 / 41 |
| serious Total, serious adverse events | 1 / 43 | 2 / 41 |
Outcome results
Primary
Algometer-induced Pressure Pain at Week 14
A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain.
Time frame: Week 14 after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Algometer-induced Pressure Pain at Week 14 | Trapezius | 379.4 kPa/cm2 | Standard Deviation 194.7 |
| Androgel (Testosterone Gel) | Algometer-induced Pressure Pain at Week 14 | Thumb | 409.7 kPa/cm2 | Standard Deviation 167.9 |
| Placebo | Algometer-induced Pressure Pain at Week 14 | Trapezius | 315.9 kPa/cm2 | Standard Deviation 151.6 |
| Placebo | Algometer-induced Pressure Pain at Week 14 | Thumb | 326.4 kPa/cm2 | Standard Deviation 187.3 |
Primary
Brief Pain Inventory (BPI) at Week 14
BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain).
Time frame: Week14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Brief Pain Inventory (BPI) at Week 14 | Total score | 10.2 units on a scale | Standard Deviation 3.8 |
| Androgel (Testosterone Gel) | Brief Pain Inventory (BPI) at Week 14 | Severity | 5.3 units on a scale | Standard Deviation 1.7 |
| Androgel (Testosterone Gel) | Brief Pain Inventory (BPI) at Week 14 | Interference | 5.0 units on a scale | Standard Deviation 2.3 |
| Placebo | Brief Pain Inventory (BPI) at Week 14 | Total score | 9.7 units on a scale | Standard Deviation 3.3 |
| Placebo | Brief Pain Inventory (BPI) at Week 14 | Severity | 5.1 units on a scale | Standard Deviation 1.6 |
| Placebo | Brief Pain Inventory (BPI) at Week 14 | Interference | 4.7 units on a scale | Standard Deviation 1.9 |
Primary
Ice Water-induced Cold Pain and Its After-sensation at Week 14
Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain.
Time frame: Week 14 after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Ice Water-induced Cold Pain and Its After-sensation at Week 14 | Cold pain tolenrance | 54.2 seconds | Standard Deviation 55.9 |
| Androgel (Testosterone Gel) | Ice Water-induced Cold Pain and Its After-sensation at Week 14 | Cold pain after sensation: 30s | 13.1 seconds | Standard Deviation 18.4 |
| Placebo | Ice Water-induced Cold Pain and Its After-sensation at Week 14 | Cold pain tolenrance | 54.1 seconds | Standard Deviation 50.9 |
| Placebo | Ice Water-induced Cold Pain and Its After-sensation at Week 14 | Cold pain after sensation: 30s | 13.9 seconds | Standard Deviation 15.1 |
Primary
Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14
Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain.
Time frame: Week 14 after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14 | First Stimulus | 10.9 watts | Standard Deviation 8.4 |
| Androgel (Testosterone Gel) | Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14 | 10th Stimulus | 21.9 watts | Standard Deviation 17.4 |
| Placebo | Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14 | First Stimulus | 11.7 watts | Standard Deviation 13.2 |
| Placebo | Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14 | 10th Stimulus | 22.2 watts | Standard Deviation 23.5 |
Secondary
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Physical functioning | 42 units on a scale | Standard Deviation 19 |
| Androgel (Testosterone Gel) | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Bodily pain | 62 units on a scale | Standard Deviation 21 |
| Androgel (Testosterone Gel) | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Role limitations due to physical health problems | 23 units on a scale | Standard Deviation 35 |
| Androgel (Testosterone Gel) | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Role limitations due to emotional problems | 56 units on a scale | Standard Deviation 42 |
| Androgel (Testosterone Gel) | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Emotional well-being | 64 units on a scale | Standard Deviation 16 |
| Androgel (Testosterone Gel) | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Social functioning | 57 units on a scale | Standard Deviation 14 |
| Androgel (Testosterone Gel) | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Energy-fatigue | 44 units on a scale | Standard Deviation 17 |
| Androgel (Testosterone Gel) | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | General health perceptions | 55 units on a scale | Standard Deviation 12 |
| Placebo | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | General health perceptions | 52 units on a scale | Standard Deviation 13 |
| Placebo | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Physical functioning | 42 units on a scale | Standard Deviation 24 |
| Placebo | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Emotional well-being | 63 units on a scale | Standard Deviation 15 |
| Placebo | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Bodily pain | 61 units on a scale | Standard Deviation 17 |
| Placebo | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Energy-fatigue | 40 units on a scale | Standard Deviation 18 |
| Placebo | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Role limitations due to physical health problems | 22 units on a scale | Standard Deviation 29 |
| Placebo | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Social functioning | 54 units on a scale | Standard Deviation 13 |
| Placebo | Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14 | Role limitations due to emotional problems | 37 units on a scale | Standard Deviation 43 |
Secondary
Pain Catastrophizing Scale (PCS) at Week 14
PCS questionnaire measures self-assessment of pain catastrophizing. This questionnaire consists of 13 items on past painful experiences and rate on 5-point scales ranging from 0 (not at all) to 4 (all the time). The PCS yields three subscale scores assessing rumination (range 0-16), magnification (range 0-12), helplessness (range 0-24), and a composite score (sum of three domains, ranging 0-52). Higher score represents worse painful experiences.
Time frame: Values at week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Pain Catastrophizing Scale (PCS) at Week 14 | Composite score | 20 units on a scale | Standard Deviation 12 |
| Androgel (Testosterone Gel) | Pain Catastrophizing Scale (PCS) at Week 14 | Rumination score | 7.1 units on a scale | Standard Deviation 4.1 |
| Androgel (Testosterone Gel) | Pain Catastrophizing Scale (PCS) at Week 14 | Magnification score | 3.7 units on a scale | Standard Deviation 2.8 |
| Androgel (Testosterone Gel) | Pain Catastrophizing Scale (PCS) at Week 14 | Helplessness score | 9.2 units on a scale | Standard Deviation 5.8 |
| Placebo | Pain Catastrophizing Scale (PCS) at Week 14 | Helplessness score | 8.4 units on a scale | Standard Deviation 4.7 |
| Placebo | Pain Catastrophizing Scale (PCS) at Week 14 | Composite score | 21 units on a scale | Standard Deviation 10 |
| Placebo | Pain Catastrophizing Scale (PCS) at Week 14 | Magnification score | 4.1 units on a scale | Standard Deviation 2.4 |
| Placebo | Pain Catastrophizing Scale (PCS) at Week 14 | Rumination score | 7.6 units on a scale | Standard Deviation 3.1 |
Secondary
Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Time frame: Week14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Total score | 51.3 units on a scale | Standard Deviation 17.5 |
| Androgel (Testosterone Gel) | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Erectile function | 21.7 units on a scale | Standard Deviation 7.9 |
| Androgel (Testosterone Gel) | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Orgasmic funcion | 7.7 units on a scale | Standard Deviation 2.9 |
| Androgel (Testosterone Gel) | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Sexual desire | 6.8 units on a scale | Standard Deviation 2.1 |
| Androgel (Testosterone Gel) | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Intercourse satisfaction | 9.1 units on a scale | Standard Deviation 5.2 |
| Androgel (Testosterone Gel) | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Overall satisfaction | 6.1 units on a scale | Standard Deviation 2.5 |
| Placebo | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Intercourse satisfaction | 9.0 units on a scale | Standard Deviation 5.4 |
| Placebo | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Total score | 47.1 units on a scale | Standard Deviation 23.1 |
| Placebo | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Sexual desire | 6.3 units on a scale | Standard Deviation 2.6 |
| Placebo | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Erectile function | 19.2 units on a scale | Standard Deviation 10.8 |
| Placebo | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Overall satisfaction | 6.1 units on a scale | Standard Deviation 3.1 |
| Placebo | Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14 | Orgasmic funcion | 6.4 units on a scale | Standard Deviation 3.4 |
Other Pre-specified
Adiponectin at Week 14
Total adiponectin was measured using an RIA kit with an interassay CV of 6.9-9.3% and an intra-assay CV of 1.8-6.2% (Millipore).
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | Adiponectin at Week 14 | 4.8 ug/mL | Standard Deviation 3 |
| Placebo | Adiponectin at Week 14 | 4.7 ug/mL | Standard Deviation 2.1 |
Other Pre-specified
Body Composition at Week 14
Body composition was measured using dual-energy X-ray absorptiometry scan.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Body Composition at Week 14 | Lean mass | 57.8 kg | Standard Deviation 7.5 |
| Androgel (Testosterone Gel) | Body Composition at Week 14 | Fat mass | 25.7 kg | Standard Deviation 8.7 |
| Androgel (Testosterone Gel) | Body Composition at Week 14 | Total mass | 83.5 kg | Standard Deviation 14.8 |
| Androgel (Testosterone Gel) | Body Composition at Week 14 | Appendicular lean mass | 27.9 kg | Standard Deviation 4.1 |
| Androgel (Testosterone Gel) | Body Composition at Week 14 | Appendicular fat mass | 11.4 kg | Standard Deviation 4.7 |
| Androgel (Testosterone Gel) | Body Composition at Week 14 | Appendicular total mass | 38.6 kg | Standard Deviation 7.9 |
| Placebo | Body Composition at Week 14 | Appendicular fat mass | 12.1 kg | Standard Deviation 4.7 |
| Placebo | Body Composition at Week 14 | Lean mass | 60.9 kg | Standard Deviation 5.9 |
| Placebo | Body Composition at Week 14 | Appendicular lean mass | 29.4 kg | Standard Deviation 3.7 |
| Placebo | Body Composition at Week 14 | Fat mass | 27.9 kg | Standard Deviation 9.7 |
| Placebo | Body Composition at Week 14 | Appendicular total mass | 40.8 kg | Standard Deviation 6.3 |
| Placebo | Body Composition at Week 14 | Total mass | 88.7 kg | Standard Deviation 12.8 |
Other Pre-specified
C-reactive Protein (CRP) at Week 14
High-sensitivity C-reactive protein (Alpco Diagnostics) was measured using a high-sensitivity sandwich ELISA with an intra-assay CV of 5.6%
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | C-reactive Protein (CRP) at Week 14 | 4.2 mg/L | Standard Deviation 4.4 |
| Placebo | C-reactive Protein (CRP) at Week 14 | 3.4 mg/L | Standard Deviation 3.3 |
Other Pre-specified
Free Testosterone Values at Week 14
Free testosterone was calculated using a law of mass action equation.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | Free Testosterone Values at Week 14 | 189 pg/mL | Standard Deviation 152 |
| Placebo | Free Testosterone Values at Week 14 | 65 pg/mL | Standard Deviation 36 |
Other Pre-specified
Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14
All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The plasma glucose level were analyzed at baseline and at 60 and 120 min after glucose loading.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | Fasting glucose | 5.2 mmol/L | Standard Deviation 1.4 |
| Androgel (Testosterone Gel) | Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | OGTT 1-h glucose | 8.0 mmol/L | Standard Deviation 3.4 |
| Androgel (Testosterone Gel) | Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | OGTT 2-h glucose | 6.7 mmol/L | Standard Deviation 3.2 |
| Placebo | Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | Fasting glucose | 5.6 mmol/L | Standard Deviation 1.4 |
| Placebo | Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | OGTT 1-h glucose | 8.3 mmol/L | Standard Deviation 2.4 |
| Placebo | Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | OGTT 2-h glucose | 6.1 mmol/L | Standard Deviation 2.6 |
Other Pre-specified
HbA1c at Week 14
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | HbA1c at Week 14 | 5.7 percentage of glycosylated hemogobin | Standard Deviation 0.01 |
| Placebo | HbA1c at Week 14 | 6.1 percentage of glycosylated hemogobin | Standard Deviation 0.01 |
Other Pre-specified
HOMA IR Score at Week 14
Insulin resistance was calculated using the homeostatic model assessment (HOMA) index: glucose \* insulin / 22.5.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | HOMA IR Score at Week 14 | 2.5 HOMA IR score | Standard Deviation 3.6 |
| Placebo | HOMA IR Score at Week 14 | 4.2 HOMA IR score | Standard Deviation 5.9 |
Other Pre-specified
Inflammatory Cytokines at Week 14
The pathophysiology of pain is measured by the proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-Alpha).
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Inflammatory Cytokines at Week 14 | IL-6 | 2.4 pg/mL | Standard Deviation 2.1 |
| Androgel (Testosterone Gel) | Inflammatory Cytokines at Week 14 | TNF-Alpha | 1.9 pg/mL | Standard Deviation 1 |
| Placebo | Inflammatory Cytokines at Week 14 | IL-6 | 2.6 pg/mL | Standard Deviation 2.7 |
| Placebo | Inflammatory Cytokines at Week 14 | TNF-Alpha | 2.1 pg/mL | Standard Deviation 2.4 |
Other Pre-specified
Insomnia Severity Index (ISI) at Week 14
ISI is comprised of 7 items assesses a participant's perception of insomnia. Each item is rated on a 5-point scale from 0 (none) to 4 (very severe). Scores from the questions are summed to assign a total score ranging from 0 to 28, where higher score represents worse insomnia problem.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | Insomnia Severity Index (ISI) at Week 14 | 10.8 units on a scale | Standard Deviation 5.2 |
| Placebo | Insomnia Severity Index (ISI) at Week 14 | 11.1 units on a scale | Standard Deviation 5.1 |
Other Pre-specified
Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14
All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The insulin level were analyzed at baseline and at 60 and 120 min after glucose loading.
Time frame: Values at week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | Fasting insulin | 70 pmol/L | Standard Deviation 88 |
| Androgel (Testosterone Gel) | Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | OGTT 1-h insulin | 279 pmol/L | Standard Deviation 181 |
| Androgel (Testosterone Gel) | Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | OGTT 2-h insulin | 231 pmol/L | Standard Deviation 210 |
| Placebo | Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | Fasting insulin | 110 pmol/L | Standard Deviation 149 |
| Placebo | Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | OGTT 1-h insulin | 407 pmol/L | Standard Deviation 318 |
| Placebo | Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14 | OGTT 2-h insulin | 325 pmol/L | Standard Deviation 275 |
Other Pre-specified
Leptin at Week 14
Leptin levels were measured using ELISA with an interassay CV of 2.6% to 6.2% and in intra-assay CV of 2.6% to 4.6% (Millipore, Billerica, MA, USA).
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | Leptin at Week 14 | 16 ug/L | Standard Deviation 12 |
| Placebo | Leptin at Week 14 | 21 ug/L | Standard Deviation 21 |
Other Pre-specified
Lipid Profile at Week 14
Serum total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol levels were measured by enzymatic assays and standardized to the CDC using the Lipid Research Clinic protocol. Low-density lipoprotein (LDL) cholesterol was calculated using the Friedewald equation.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androgel (Testosterone Gel) | Lipid Profile at Week 14 | Total cholesterol | 4.8 mmol/L | Standard Deviation 1.2 |
| Androgel (Testosterone Gel) | Lipid Profile at Week 14 | LDL | 2.9 mmol/L | Standard Deviation 1 |
| Androgel (Testosterone Gel) | Lipid Profile at Week 14 | HDL | 1.0 mmol/L | Standard Deviation 0.4 |
| Androgel (Testosterone Gel) | Lipid Profile at Week 14 | Triglycerides | 1.8 mmol/L | Standard Deviation 1 |
| Placebo | Lipid Profile at Week 14 | Triglycerides | 1.9 mmol/L | Standard Deviation 1 |
| Placebo | Lipid Profile at Week 14 | Total cholesterol | 5.1 mmol/L | Standard Deviation 1.1 |
| Placebo | Lipid Profile at Week 14 | HDL | 1.1 mmol/L | Standard Deviation 0.4 |
| Placebo | Lipid Profile at Week 14 | LDL | 3.1 mmol/L | Standard Deviation 1 |
Other Pre-specified
Luteinizing Hormone Values at Week 14
Luteinizing hormone was measured using immunofluorometric assays, with limits of quantification of 0.05 U/L.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | Luteinizing Hormone Values at Week 14 | 1.6 U/L | Standard Deviation 2.2 |
| Placebo | Luteinizing Hormone Values at Week 14 | 3.5 U/L | Standard Deviation 2.3 |
Other Pre-specified
Sex Hormone Binding Globulin (SHBG) at Week 14
Sex hormone binding globulin was measured using immunofluorometric assays, with limits of quantification of 2.5 nmol/L.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | Sex Hormone Binding Globulin (SHBG) at Week 14 | 34.6 nmol/L | Standard Deviation 18.2 |
| Placebo | Sex Hormone Binding Globulin (SHBG) at Week 14 | 35.0 nmol/L | Standard Deviation 14.3 |
Other Pre-specified
Total Testosterone Values at Week 14
Total testosterone was measured in a CDC-certified laboratory using an LC-MS/MS method with a sensitivity of 2 ng/dL.
Time frame: Week 14 after intervention
Population: All available data expressed as absolute values at week 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androgel (Testosterone Gel) | Total Testosterone Values at Week 14 | 790 ng/dL | Standard Deviation 544 |
| Placebo | Total Testosterone Values at Week 14 | 328 ng/dL | Standard Deviation 185 |