Healthy Volunteers Clinical Trial
Official title:
Dose-Response of Gonadal Steroids and Bone Turnover in Older Men
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.
In this protocol, men age 60-75 will be randomized to one of 6 groups. Groups 1-5 will
receive goserelin acetate (Zoladex) plus 0 (placebo gel), 1.25, 2.5, 5, or 10* g/day of
testosterone gel (Androgel). Group 6 will receive placebos for both goserelin acetate and
testosterone gel. (*Note that the 10 g/day dose was reduced to 7.5 g/day part-way through the
trial due to reports of possible increased risk of cardiovascular events with testosterone
administration).
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 Clinical Research Center 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. Dual-energy
x-ray absorptiometry (DXA), quantitate computed tomography (QCT) 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:
- Routine chemistries and prostate specific antigen, PSA (for safety assessment)
- Bone turnover using blood and urine tests
- Hormones
- Lipids
- Body composition
- Strength
- Sexual desire and erectile function
- Bone mineral density and bone microarchitecture
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
| Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
| Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
| Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
| Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
| Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
| Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
| Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
| Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
| Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
| Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
| Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
| Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
| Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
| Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |