Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

Hypogonadism Clinical Trial

Official title:

An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104246
• Other study ID #: AND1001
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2010
• Last updated: October 2, 2012
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2012
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Description:

Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males in good general health, 18 years of age or older.

• Have a previously documented testosterone deficiency.

• Willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

• Have a history of intolerance to Androderm or other testosterone products.

• Prostate specific antigen (PSA) level = 4.0 ng/mL

• Prostate cancer or severe benign prostatic hypertrophy (BPH)

• Have significant abnormalities in the physical examination at screening.

• Have current dermatological disease, skin damage or blemishes.

• Have participated in an investigational drug study within 30 days prior to screening.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testerone Transdermal System
Transdermal testosterone applied daily for 4 weeks

Locations

Country	Name	City	State
United States	Watson investigational site	Miramar	Florida
United States	Watson investigational site	Omaha	Nebraska
United States	Watson investigational site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours	A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.	Day 28/29	No