Phase 3
N=790
The Testosterone Trials in Older Men
Andropause
Bottom Line
View on ClinicalTrials.gov: NCT00799617 ↗Enrolled (actual)
790
Serious AEs
45.6%
Results posted
Aug 2017
Primary outcome: Primary: Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12 — 1.4; 1.4; 0.6; 0.1 units on the PDQ-Q4 scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AndroGel® (testosterone gel) (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- Male
- Sponsor
- University of Pennsylvania
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12 |
1.4; 1.4; 0.6; 0.1; 0.6; -0.1 | <0.001 sig |
| PRIMARY Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%) |
20; 14; 24; 23; 28; 22 | 0.20 |
| PRIMARY Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%) |
148; 138; 144; 126; 148; 127 | 0.30 |
| PRIMARY Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume |
54; 14 | .003 sig |
| PRIMARY Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone |
7.5; 0.8 | <.001 sig |
| PRIMARY Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) |
14.0; 14.4; 1.1; 1.1; 1.3; 1.4 | .88 |
| PRIMARY Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia |
6; 4; 8; 3; 15; 2 | .002 sig |
| SECONDARY Sexual Function Trial - Sexual Desire Domain |
11.9; 11.6; 3.5; 0.7; 3.5; 0.8 | <0.001 sig |
| SECONDARY Sexual Function Trial - Erectile Function |
8.0; 7.7; 3.4; 1.0; 3.3; 0.5 | <0.001 sig |
| SECONDARY Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters |
347.7; 344.9; 10.2; 4.6; 8.2; 7.8 | 0.28 |
| SECONDARY Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%) |
77; 59; 72; 73; 77; 60 | 0.15 |
| SECONDARY Physical Function Trial - PF 10 Overall Score |
65.4; 64.8; 5.6; 4.2; 6.5; 4.8 | 0.03 sig |
| SECONDARY Vitality Trial - FACIT Fatigue Overall Score |
31.6; 31.3; 7.8; 7.2; 7.4; 5.9 | 0.06 |
| SECONDARY Vitality Trial - SF-36 Score |
50.6; 49.4; 7.4; 5.9; 7.2; 4.5 | 0.03 sig |
| SECONDARY Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12. |
15.3; 15.4; 0.7; 0.3; 0.9; 0.0 | 0.04 sig |
| SECONDARY Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12 |
7.5; 7.4; -0.2; 0.3; -0.4; 0.4 | <0.001 sig |
| SECONDARY Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score |
6.6; 6.6; -1.3; -0.8; -1.7; -0.5 | 0.004 sig |
| SECONDARY Cardiovascular Trial - Total Plaque Volume Change From Baseline |
75; 28 | .006 sig |
| SECONDARY Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline |
64; 91 | .31 |
| SECONDARY Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT) |
4.0; 1.1 | <.001 sig |
| SECONDARY Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT) |
5.5; 1.2 | <.001 sig |
| SECONDARY Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT) |
1.6; 0.1 | <.001 sig |
| SECONDARY Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT) |
1.6; 0.7 | <.001 sig |
| SECONDARY Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT) |
1.7; 0.4 | <.001 sig |
| SECONDARY Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N |
9.0; 1.9 | <.001 sig |
| SECONDARY Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N |
10.8; 2.4 | <.001 sig |
| SECONDARY Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N |
7.2; 1.5 | <.001 sig |
| SECONDARY Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N |
2.5; 0.6 | <.001 sig |
| SECONDARY Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N |
1.5; 0.5 | .005 sig |
| SECONDARY Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N |
1.4; 0.4 | <.001 sig |
| SECONDARY Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA) |
3.3; 2.1 | .01 sig |
| SECONDARY Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA) |
1.2; 0.5 | .052 |
| SECONDARY Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA) |
1.5; 0.9 | 0.27 |
| SECONDARY Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT) |
-8.2; -8.2; 0.2; 0.3; 0.3; 0.7 | .24 |
| SECONDARY Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT) |
28.7; 30.0; 0.6; 0.2; 0.6; 1.2 | .89 |
| SECONDARY Cognitive Function Trial - Executive Function - Trail Making Test B - A |
86.4; 76.7; -2.1; 1.8; -0.0; 7.1 | .14 |
| SECONDARY Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous) |
0.9; 0.2 | <.001 sig |
Summary
The Testosterone Trials are a multi-center set of trials involving 12 clinical sites geographically distributed across the United States.
The primary specific aims are to test the hypotheses that testosterone treatment of elderly men whose serum testosterone concentrations are unequivocally low - and who have symptoms and objectively measured abnormalities in at least one of five areas that could be due to low testosterone (physical or sexual function, vitality, cognition, and anemia) - will result in more favorable changes in those abnormalities than placebo treatment.
Two additional trials have been incorporated into the T Trial. Only men enrolled in the T Trial are eligible to participate in these trials.
* The Cardiovascular Trial will examine if testosterone treatment results in more favorable changes in cardiovascular risk factors, compared to placebo.
* The Bone Trial will test the hypothesis that testosterone treatment will increase volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by quantitative computed tomography (QCT), compared with placebo treatment.
A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional T Trial. It will examine the variability of the serum testosterone (T) concentration after application of testosterone gel or placebo, four months after the start of treatment.
Eligibility Criteria
Inclusion Criteria
- Men greater than or equal to 65 years old
- Total serum testosterone concentration 35% risk of having overall prostate cancer or >7% risk of having high grade prostate cancer
- Severe lower urinary tract symptoms (score of > 19) by the International Prostate Symptom Score questionnaire
- Hemoglobin 16.0 g/dL
- Sleep apnea, diagnosed but untreated
- Alcohol or substance abuse within the past year (based on self report)
- Angina not controlled by treatment
- NYHA class III or IV congestive heart failure
- Myocardial infarction within the previous 3 months before entry
- Stroke within the previous 3 months before entry
- Severe pulmonary disease that precludes physical function tests
- Serum creatinine >2.2 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c >8.5%, TSH > 7.5mIU/L
- Diagnosis or treatment for cancer within the past 3 years, with the exception of nonmelanotic skin cancer
- Body mass index (BMI) >37 kg/m2
- Mini Mental State Exam (MMSE) Score 14), mania, hypomania, psychosis, schizophrenia or schizoaffective disorders, that are untreated, unstable, have resulted in hospitalization or medication change within the previous three months, or would result in inability to complete the trial efficacy instruments. Subjects whose disorders have been stable while being treated for more than three months are eligible.
- Use of the following medications within the previous three months:
- drugs that affect serum testosterone concentration
- rhGH or megestrol acetate
- introduction of anti-depressant medication
- daily use of prednisone for more than two weeks
- Opiate use within the past three months
- Skin conditions at the testosterone gel application site, such as ulcer, erosion, lichenification, inflammation, or crust, or generalized skin conditions such as psoriasis or eczema that might affect testosterone absorption or tolerability of the testosterone gel
- Known skin intolerance to alcohol or allergy to any of the ingredients of testosterone gel
Participants in the T Trial may also enroll in the Cardiovascular and Bone Trials if it is determined that they are eligible based on the specific exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT00799617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.