Phase 3
N=159
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
Adult Male Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT02149264 ↗Enrolled (actual)
159
Serious AEs
3.1%
Results posted
Jul 2017
Primary outcome: Primary: The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL — 76.1 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Testosterone gel (FE 999303) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL |
76.1 | — |
| SECONDARY The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL |
29.1; 58.2; 71.2 | — |
| SECONDARY Change From Baseline in International Index of Erectile Function (IIEF) Score |
8.4; 14.4 | — |
| SECONDARY Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score |
-3.6; -1.7; -13.6; -2.6; -8.3; -5.2 | — |
| SECONDARY Change From Baseline in Short Form-12 Health Survey (SF-12) Score |
1.2; 1.8; 6.3; 6.5 | — |
| SECONDARY Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone |
268; 359; 361; 278; 429; 464 | — |
| SECONDARY Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone |
6431; 8552; 8665; 6624; 10320; 11152 | — |
| SECONDARY Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone |
2.04; 2.15; 2.00; 2.00; 2.08; 2.00 | — |
| SECONDARY Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone |
435; 642; 732; 637; 890; 987 | — |
| SECONDARY Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone |
194; 203; 216; 175; 262; 261 | — |
Summary
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
Eligibility Criteria
Inclusion Criteria
- Males between 18-75 years of age
- Two fasting serum testosterone levels <300 ng/dL
Exclusion Criteria
- Previous use of the study drug
- History of prostate or breast cancer
- Prostate-Specific Antigen (PSA) ≥3 ng/mL
- Subject is sexually active and not willing to use adequate contraception
Data sourced from ClinicalTrials.gov (NCT02149264). 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.