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| Sponsors and Collaborators: |
Massachusetts General Hospital National Institute on Aging (NIA) Solvay Pharmaceuticals AstraZeneca |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00114114 |
Purpose
The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur. This information may help determine when to intervene with hormone replacement therapy in aging men.
| Condition | Intervention |
|---|---|
|
Healthy Volunteers |
Drug: testosterone Drug: goserelin acetate Drug: anastrazole |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Dose-Response of Gonadal Steroids and Bone Turnover in Men |
| Estimated Enrollment: | 900 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Zoladex plus testosterone (or placebo) in men age 20-50
|
Drug: testosterone
Androgel placebo or 1.25, 2.5, 5. or 10 gms topically each day
Drug: goserelin acetate
3.6 gms sc every 4 weeks
|
|
2: Placebo Comparator
Zoladex plus testosterone (or placebo) plus anastrazole in men age 20-50
|
Drug: testosterone
Androgel placebo or 1.25, 2.5, 5. or 10 gms topically each day
Drug: goserelin acetate
3.6 gms sc every 4 weeks
Drug: anastrazole
1 mg by mouth daily
|
|
3: Placebo Comparator
Zoladex plus testosterone (or placebo) in men over age 60
|
Drug: testosterone
Androgel placebo or 1.25, 2.5, 5. or 10 gms topically each day
Drug: goserelin acetate
3.6 gms sc every 4 weeks
|
There are 3 arms to this protocol, each with 5 or 6 groups.
In Arm 1, 240 men age 20-50 will receive goserelin acetate (Zoladex) plus Androgel (or placebo). (Note Arm 1 is closed to recruitment).
In Arm 2, 200 men age 20-50 will receive goserelin acetate (Zoladex) plus Androgel (or placebo) plus anastrazole (Arimidex). (Arm 2 is recruiting).
In Arm 3, 240 men age 60 or greater will receive goserelin acetate (Zoladex) plus Androgel (or placebo). (Arm 3 is recruiting).
For each arm, subjects will be screened on the MGH General Clinical Research Center (GCRC). After obtaining informed consent for the screening procedures, subjects will undergo a complete history and physical examination. If no exclusionary findings are noted during the history and physical examination, blood will be drawn to measure hemoglobin, routine chemistries (including serum calcium, liver function tests, and creatinine), and serum levels of PTH, 25-OH vitamin D, TSH, T, and PSA.
Subjects who are successfully screened will be randomly assigned by a computer to one of 5 groups. All subjects will receive a GnRH agonist goserelin acetate (Zoladex; AstraZeneca, Wilmington, DE) 3.6 mg sc every 4 weeks for 16 weeks. Subjects in Group 1 will receive goserelin acetate and placebo for Androgel. Subjects in Groups 2-5 will receive varying doses of Androgel. In Arms 1 and 3, a sixth group will receive double placebo (e.g. placebo Zoladex and placebo Androgel). Subjects will be blinded with respect to group assignment. Dietary calcium intake will be assessed by a research dietitian and adjustments made through diet or supplements so that calcium intake is between 1000 and 1200 mg/day.
Subjects will be seen on the GCRC at 4 week intervals for 16 weeks (0, 4, 8, 12, and 16 weeks). At each visit, compliance with Androgel' will be assessed by reviewing a medication diary. A standardized series of questions will be posed to each subject to assess potential side effects of the study drugs. Subjects receiving Androgel' will be given a new 4 week supply of medication (except at week 16). A fasting blood and second voided urine sample will be collected. After the blood and urine samples have been obtained, subjects will be given their goserelin injection. The blood and urine tests listed below as well as anthropometric measures, and questionnaires will be performed at each visit. DXA, CT scans, and strength assessments will be performed at 0 and 16 weeks only. Subjects who discontinue participation at or after week 8 will be asked if they are willing to have an early discontinuation visit in which all procedures normally done at week 16 will be performed.
The following measures will be assessed:
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: JOEL S. FINKELSTEIN, MD | 617-726-6723 | jfinkelstein@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: JOEL S. FINKELSTEIN, MD 617-726-6723 jfinkelstein@partners.org | |
| Contact: Benjamin Z Leder, MD 617-726-6723 bzleder@partners.org | |
| Principal Investigator: JOEL S. FINKELSTEIN, MD | |
| Principal Investigator: | JOEL S. FINKELSTEIN, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( Joel S. Finkelstein, M.D. Principal Investigator ) |
| Study ID Numbers: | 2003-P-001868 |
| Study First Received: | June 13, 2005 |
| Last Updated: | December 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00114114 |
| Health Authority: | United States: Institutional Review Board |
|
Testosterone Bone turnover Aging |
Body composition Hypogonadism Sexual function |
|
Testosterone Anastrozole Hypogonadism Goserelin |
Methyltestosterone Healthy Testosterone 17 beta-cypionate |
|
Anabolic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Aromatase Inhibitors Hormones Pharmacologic Actions Androgens |
