Phase 2
Completed N=40
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Source: ClinicalTrials.gov NCT01323140 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Percent of Subjects With Testosterone Levels in the Normal Range. — 68.4 percentage of participants
Summary
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects With Testosterone Levels in the Normal Range. |
68.4 | — |
Eligibility Criteria
Inclusion Criteria
- Male, 18 - 65 years of age;
- Documented testosterone deficiency;
- BMI 18 to 33.
Exclusion Criteria
- Evidence of prostate cancer and benign prostate hyperplasia;
- Taking medications that interfere testosterone metabolism;
- History of alcohol or drug substance abuse;
- Abnormal ECG;
- Allergic to transdermal products;
- Skin condition that interfere transdermal system application and assessment
Data sourced from ClinicalTrials.gov (NCT01323140). 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. Informational only — not medical advice.