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

Phase 1

Completed

• Conditions: Hypogonadism
• Interventions: Drug: Testerone Transdermal System

• Registration Number: NCT01104246
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-02-01
• Results First Submitted QC: 2011-02-01
• Results First Posted: 2011-02-23
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Testosterone Transdermal Systems	Testerone Transdermal System	Testosterone

Primary Outcome Measures

Name	Time	Method
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours	Day 28/29	A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.

Trial Locations

Locations (1)

Watson investigational site; 🇺🇸 San Antonio, Texas, United States