Phase 3
Completed N=145
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
Adult Male Hypogonadism
Source: ClinicalTrials.gov NCT01703741 ↗
Enrolled (actual)
145
Serious AEs
0.7%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL — 5.7; 2.8; 2.8 percentage of subjects
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL |
5.7; 2.8; 2.8 | — |
| SECONDARY Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL. |
82.1 | — |
| SECONDARY Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire |
19.8; 7.3; 7.0; 8.7; 6.7 | — |
| SECONDARY Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire |
44.1 | — |
| SECONDARY Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire |
6.6; 2.8; 28.3; 10.1; 15.3 | — |
| SECONDARY Domain Scores for the Short Form-12 (SF-12) Questionnaire |
54.3; 51.7; 50.2; 51.1; 51.9; 48.8 | — |
| SECONDARY Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL |
6.7; 2.9; 1.9 | — |
| SECONDARY Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone |
7732; 10583; 10842; 10451; 1361; 1675 | — |
| SECONDARY Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone |
3.09; 2.11; 3.97; 3.88; 3.96; 4.00 | — |
| SECONDARY Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone |
747; 1085; 999; 1008; 88.7; 111 | — |
| SECONDARY Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone |
162; 201; 219; 207; 34.8; 43.5 | — |
| SECONDARY Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone |
322; 438; 449; 433; 56.6; 69.3 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of the Phase 3 protocol (NCT01665599)
Exclusion Criteria
- Use of another investigational product
- Use of any medications that could be considered anabolic or interfere with androgen metabolism
- Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone
- Use of another testosterone product
- Chronic use of any drug of abuse
Data sourced from ClinicalTrials.gov (NCT01703741). 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.