Phase 3
N=180
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
Adult Male Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01665599 ↗Enrolled (actual)
180
Serious AEs
1.7%
Results posted
Sep 2017
Primary outcome: Primary: The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL — 2.9; 4.7; 77.9; 85.5 percentage of participants
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
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL |
2.9; 4.7; 77.9; 85.5 | — |
| SECONDARY The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL |
51.7 | — |
| SECONDARY Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) |
7,616; 12,433; 9,835; 11,967; 11,825 | — |
| SECONDARY Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax) |
4; 4; 2.01; 2.03; 2.03 | — |
| SECONDARY Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax) |
490; 944; 916; 1,432; 1,382 | — |
| SECONDARY Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave) |
316; 515; 407; 495; 489 | — |
| SECONDARY Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin) |
201; 317; 219; 222; 225 | — |
| SECONDARY Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin) |
0; 8.00; 12.1; 12.0; 12.0 | — |
| SECONDARY Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ |
982; 1,537; 1,329; 1,604; 1,582 | — |
| SECONDARY Pharmacokinetics of DHT Measuring Tmax |
6; 4.08; 2.11; 3.98; 3.97 | — |
| SECONDARY Pharmacokinetics of DHT Measuring Cmax |
58.7; 92.1; 82.5; 108; 106 | — |
| SECONDARY Pharmacokinetics of DHT Measuring Cave |
40.8; 63.7; 55.1; 66.3; 65.4 | — |
| SECONDARY Pharmacokinetics of DHT Measuring Cmin |
18.0; 45.4; 35.7; 42.8; 42.4 | — |
| SECONDARY Pharmacokinetics of DHT Measuring Tmin |
0; 8.00; 16.0; 12.0; 12.0 | — |
| SECONDARY Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire |
13.8 | — |
| SECONDARY Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire |
-5.3; -2.0; -18.9; -2.8; -11.4 | — |
| SECONDARY Change From Baseline in the SF-12 Health Questionnaire |
3.7; 7.9 | — |
Summary
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.
Eligibility Criteria
Inclusion Criteria
- Males between 18-75 years of age
- Two screening serum testosterone values less than 300 ng/dL
- One or more symptoms of testosterone deficiency
Exclusion Criteria
- Previous use of the investigational product
- Use of any investigational product within 30 days prior to screening and during the study
- BMI less than 18 kg/m^2 or more than 35 kg/m^2
- Prostatic mass(es)
- Generalized skin irritation or skin disease
- Lower urinary tract obstruction
- Myocardial infarction or cerebrovascular accident in the last 6 months
- Unstable angina or congestive heart failure
- Thromboembolic disorders
- Sleep apnea
- Hyperparathyroidism or uncontrolled diabetes
- Untreated moderate to severe depression
- History of testicular, prostate, or breast cancer
- HIV, Hepatitis B, or Hepatitis C positive
- PSA more or equal to 3 ng/mL
- Use of any medications that could be considered anabolic
- Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
- Chronic use of any drug of abuse
- Involvement in a sport in which there is a screening for anabolic steroids
- Not willing to use adequate contraception during the study
- Partner is pregnant and/or breast feeding
- Partner has a history of breast, uterine or ovarian cancer
Data sourced from ClinicalTrials.gov (NCT01665599). 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.