NCT00114114

Brief Summary

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 in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2005

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 17, 2019

Completed
Last Updated

October 8, 2019

Status Verified

September 1, 2019

Enrollment Period

13.2 years

First QC Date

June 13, 2005

Results QC Date

August 2, 2019

Last Update Submit

September 27, 2019

Conditions

Healthy Volunteers

Keywords

TestosteroneBone turnoverAgingBody compositionHypogonadismSexual function

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX)

    Baseline and 16 weeks

Secondary Outcomes (4)

  • Percentage Change in Body Composition: Fat Mass

    Baseline and 16 weeks

  • Percentage Change in Thigh Muscle Area

    Baseline and 16 weeks

  • Change in Erectile Function Symptoms

    Baseline and 16 weeks

  • Change in Libido / Sexual Desire

    16 weeks

Study Arms (6)

Group 1: 0 g/day

EXPERIMENTAL

Zoladex plus Placebo Testosterone (T) gel

Drug: TestosteroneDrug: Goserelin acetate

Group 2: 1.25 g/day

EXPERIMENTAL

Zoladex plus 1.25 g/day T gel

Drug: TestosteroneDrug: Goserelin acetate

Group 3: 2.5 g/day

EXPERIMENTAL

Zoladex plus 2.5 g/day T gel

Drug: TestosteroneDrug: Goserelin acetate

Group 4: 5 g/day

EXPERIMENTAL

Zoladex plus 5 g/day T gel

Drug: TestosteroneDrug: Goserelin acetate

Group 5: 10* g/day

EXPERIMENTAL

Zoladex plus 10\* g/day T gel. \*Note that the 10 g/day dose was reduced to 7.5 g/day part-way through the trial

Drug: TestosteroneDrug: Goserelin acetate

Group 6: Placebo/Placebo (PBO/PBO)

EXPERIMENTAL

Placebo Zoladex plus Placebo T gel (controls)

Drug: TestosteroneDrug: Goserelin acetate

Interventions

TestosteroneDRUG

Androgel placebo or 1.25, 2.5, 5. or 10\* gms topically each day

Also known as: Androgel
Group 1: 0 g/dayGroup 2: 1.25 g/dayGroup 3: 2.5 g/dayGroup 4: 5 g/dayGroup 5: 10* g/dayGroup 6: Placebo/Placebo (PBO/PBO)
Goserelin acetateDRUG

3.6 gms sc every 4 weeks

Also known as: Zoladex
Group 1: 0 g/dayGroup 2: 1.25 g/dayGroup 3: 2.5 g/dayGroup 4: 5 g/dayGroup 5: 10* g/dayGroup 6: Placebo/Placebo (PBO/PBO)

Eligibility Criteria

Age60 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men age 60 to 75

You may not qualify if:

  • History of significant cardiac, renal, pulmonary, hepatic, benign prostatic hyperplasia, or malignant disease, current alcohol or illicit drug abuse, or major psychiatric disorders.
  • Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease.
  • Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates, calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day), or anti-convulsants.
  • Cognitive or intellectual impairment that precludes complete understanding of the study protocol.
  • History of deep vein thrombosis, pulmonary embolism, or clotting disorders.
  • Serum 25-hydroxyvitamin D \< 15 ng/mL
  • Serum parathyroid hormone (PTH) \< 10 or \> 65 pg/mL
  • Serum thyroid stimulating hormone (TSH) \< 0.5 or \> 5.0 U/L
  • Serum calcium \> 10.6 mg/dL
  • Serum creatinine \> 2 mg/dL
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2x the upper limit of normal
  • Serum bilirubin \> 2 mg/dL
  • Serum alkaline phosphatase \> 150 U/L
  • Plasma hemoglobin \< 11 gm/dL
  • Hematocrit \> 50
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • Finkelstein JS, Lee H, Burnett-Bowie SM, Darakananda K, Gentile EC, Goldstein DW, Prizand SH, Krivicich LM, Taylor AP, Wulczyn KE, Leder BZ, Yu EW. Dose-Response Relationships Between Gonadal Steroids and Bone, Body Composition, and Sexual Function in Aging Men. J Clin Endocrinol Metab. 2020 Aug 1;105(8):2779-88. doi: 10.1210/clinem/dgaa318.

    PMID: 32480409DERIVED

  • Bachmann KN, Huang S, Lee H, Dichtel LE, Gupta DK, Burnett JC Jr, Miller KK, Wang TJ, Finkelstein JS. Effect of Testosterone on Natriuretic Peptide Levels. J Am Coll Cardiol. 2019 Mar 26;73(11):1288-1296. doi: 10.1016/j.jacc.2018.12.062.

    PMID: 30898204DERIVED

  • Finkelstein JS, Lee H, Leder BZ, Burnett-Bowie SA, Goldstein DW, Hahn CW, Hirsch SC, Linker A, Perros N, Servais AB, Taylor AP, Webb ML, Youngner JM, Yu EW. Gonadal steroid-dependent effects on bone turnover and bone mineral density in men. J Clin Invest. 2016 Mar 1;126(3):1114-25. doi: 10.1172/JCI84137. Epub 2016 Feb 22.

    PMID: 26901812DERIVED

  • Finkelstein JS, Lee H, Burnett-Bowie SA, Pallais JC, Yu EW, Borges LF, Jones BF, Barry CV, Wulczyn KE, Thomas BJ, Leder BZ. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med. 2013 Sep 12;369(11):1011-22. doi: 10.1056/NEJMoa1206168.

    PMID: 24024838DERIVED

MeSH Terms

Conditions

Hypogonadism

Interventions

TestosteroneGoserelin

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Results Point of Contact

Title
Dr. Ben Leder
Organization
Massachusetts General Hospital
bzleder@partners.org
617-726-6723

Study Officials

  • Ben Z Leder, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2005

First Posted

June 14, 2005

Study Start

September 1, 2004

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

October 8, 2019

Results First Posted

September 17, 2019

Record last verified: 2019-09

Locations

US(1)