Testicular Hypogonadism Clinical Trial
Official title:
A Phase 2 Open-Label, Sequential Dose Escalation Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Three Volumes (1.25, 2.50 and 3.75 mL) of Testosterone Gel 2% (FE 999303) Equivalent to 23, 46 And 70 mg of Testosterone in Hypogonadal Males
| Verified date | November 2016 |
| Source | Ferring Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Ages 18-65 - History of hypogonadism - In good health based on medical history, physical examination and clinical laboratory tests - Screening morning serum testosterone = 297 ng/dL - One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature) - Body mass index (BMI) between 18 and 31 Exclusion Criteria: - Prostate cancer - Palpable prostatic mass(es) - Generalized skin irritation or significant skin disease - Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride, ketoconazole) - Clinically significant anemia or renal dysfunction - Hyperparathyroidism or uncontrolled diabetes - Serum PSA Levels; = 4ng/mL - History of cardiovascular disease - Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months) - Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | AccuMed Research Associates | Garden City | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Responder Rate - the percentage of subjects whose Cmin and Cavg serum testosterone levels are between 298 and 1043 ng/dL | From baseline to Day 43 | No | |
| Secondary | Pharmacokinetics (abdomen) - PK parameters, Cmax (ng/ml), t1/2 (hr), Tmax (ng/ml), AUC0-t (ng/ml*hr), will be calculated based on plasma concentrations of testosterone after an initial single treatment (testosterone) on the abdomen | Days 1, 8 and 13 | No | |
| Secondary | Pharmacokinetics (inner thigh) - PK parameters, Cmax (ng/ml), t1/2 (hr), Tmax (ng/ml), AUC0-t (ng/ml*hr), will be calculated based on plasma concentrations of testosterone after an initial single treatment (testosterone) on the inner thigh | Days 1, 8 and 13 | No | |
| Secondary | Pharmacokinetics (shoulders/upper arm) - PK parameters, Cmax (ng/ml), t1/2 (hr), Tmax (ng/ml), AUC0-t (ng/ml*hr), will be calculated based on plasma concentrations of testosterone after an initial single treatment (testosterone) on shoulders/upper arm | Days 1, 8 and 13 | No | |
| Secondary | PK parameters - Cmax (ng/ml), t1/2 (hr), Tmax (ng/ml), AUC0-t (ng/ml*hr), for T, Free T and DHT; derived from plasma concentration versus time profiles to determine the multiple-dose profile of study drug after 10 days of treatment to shoulder/upper arm | Day 43 | No | |
| Secondary | Frequency of adverse events | From baseline to Day 43 | Yes |