Clinical Trials Logo
  1. Home
  2. Hypogonadism
  3. NCT00372008
  4. Details
NCT00372008 Clinical Trial

Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

Hypogonadism Clinical Trial

Official title:
A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00372008
Other study ID # MTE05
Secondary ID
Status Completed
Phase Phase 2
First received September 5, 2006
Last updated June 18, 2008
Start date October 2006
Est. completion date April 2007

Study information
Verified date June 2008
Source Acrux DDS Pty Ltd
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion Criteria:

- Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone

Locations
Country Name City State
United States Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
Acrux DDS Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic
Secondary Safety and tolerability
See also
  Status Clinical Trial Phase
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Terminated NCT02419105 - Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors Phase 3
Withdrawn NCT02137265 - Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism N/A
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 NCT00119483 - Older Men and Testosterone N/A
Completed NCT00838838 - Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis 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 Natesto™ 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 NCT00857454 - A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations Phase 3