Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00431197
Other study ID # 344-03
Secondary ID Minn # 22270
Status Completed
Phase Phase 1
First received February 2, 2007
Last updated January 26, 2010
Start date February 2004
Est. completion date December 2007

Study information

Verified date January 2010
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is being done to learn how the male hormone , testosterone, affects pituitary hormones in younger and older men. The pituitary is a gland in the brain that secretes hormones, some of which normally control growth and fertility.


Description:

Concentrations of bioavailable testosterone decline by 1.0-1.5% annually as men age. Reduced systemic testosterone availability is associated with decreased muscle mass, strength and aerobic capacity, decreased bone-mineral density and increased risk of hip fracture, waning sexual interest, inpaired spatial cognition and increased risk of visceral obesity, impaired glucose tolerance and coronary artery disease. Luteinizing hormone (LH) secretion often fails in healthy older individuals. In addition, aging is marked by an acceleration of LH pulse frequency, loss of high-amplitude LH pulses and disorderly release of LH and testosterone, as measured by the approximate entropy statistic. The mechanisms that underlie such complex adaptations are not known, but appear to involve multiple loci of regulatory failure.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 80 Years
Eligibility - Healthy Men Ages 18-80

- All ethnicities eligible

- Men with indeterminate erectile dysfunction eligible with normal serum gonadotropin, total testosterone, prolactin and TSH concentrations and documented integrity of the neurovascular, cardiovascular, hepatorenal systems

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind


Related Conditions & MeSH terms


Intervention

Drug:
Ketoconazole, Dexamethesone, Androgel,GnRH


Locations

Country Name City State
United States Mayo Clinic and Foundation Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary LH and Testosterone levels will be evaluated after 4 study visits
Secondary Unknown
See also
  Status Clinical Trial Phase
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Withdrawn NCT02137265 - Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism N/A
Terminated NCT02419105 - Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors Phase 3
Completed NCT02222558 - Oral Testosterone for the Treatment of Hypogonadism in Males Phase 2
Completed NCT02233751 - Pharmacokinetic Study of Subcutaneous Testosterone Enanthate Phase 1
Completed NCT01887418 - Pharmacokinetic Study of Testosterone Enanthate Phase 1/Phase 2
Terminated NCT01092858 - NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH) Phase 4
Completed NCT00624624 - Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism N/A
Completed NCT00752869 - Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement Phase 4
Completed NCT00613288 - Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism N/A
Completed NCT00838838 - Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis N/A
Completed NCT00119483 - Older Men and Testosterone N/A
Completed NCT00004438 - Leuprolide in Treating Adults With Hypogonadotropism N/A
Withdrawn NCT00398034 - Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study. Phase 2
Completed NCT02937740 - Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natestoâ„¢ Phase 4
Completed NCT02921386 - The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate Phase 2
Completed NCT01717768 - Oral Testosterone for the Treatment of Hypogonadism Phase 2
Terminated NCT01460654 - Testosterone and Alendronate in Hypogonadal Men Phase 2
Completed NCT00998933 - Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure Phase 1
Completed NCT00663793 - ORAL T-6: Oral Androgens in Man-6 Phase 1