Phase 1
N=40
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01104246 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours — 463 ng/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Testerone Transdermal System (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Watson Pharmaceuticals
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours |
463 | — |
Summary
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01104246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.