ADVERSE REACTIONS
In a controlled clinical study, 304 patients were treated with Testim® 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred-five (205) patients received Testim® 50 mg or 100 mg daily and 99 patients received placebo. Patients with adverse events that were possibly or probably related to study drug and reported by ≥1% of the Testim® patients and greater than placebo are listed in Table 3.
Table 3: Incidence of Adverse Events Judged Possibly, Probably or Definitely Related to Use of Testim® in the Controlled Clinical Trial | Event | Testim®50 mg | Testim®100 mg | Placebo |
|---|
| Application Site Reactions | 2% | 4% | 3% |
| Benign Prostatic Hyperplasia | 0% | 1% | 1% |
| Blood Pressure Diastolic Decreased | 1% | 0% | 0% |
| Blood Pressure Increased | 1% | 1% | 0% |
| Gynecomastia | 1% | 0% | 0% |
| Headache | 1% | 1% | 0% |
| Hematocrit/hemoglobin Increased | 1% | 2% | 0% |
| Hot Flushes | 1% | 0% | 0% |
| Insomnia | 1% | 0% | 0% |
| Lacrimation Increased | 1% | 0% | 0% |
| Mood Swings | 1% | 0% | 0% |
| Smell Disorder | 1% | 0% | 0% |
| Spontaneous Penile Erection | 1% | 0% | 0% |
| Taste Disorder | 1% | 1% | 0% |
The following adverse events possibly or probably related to Testim® occurred in fewer than 1% of patients but were greater in Testim® groups compared to the placebo group: activated partial thromboplastin time prolonged, blood creatinine increased, prothrombin time prolonged, appetite increased, sensitive nipples, and acne.
In this clinical trial of Testim®, six patients had adverse events that led to their discontinuation. These events included: vertigo, coronary artery disease, depression with suicidal ideation, urinary tract infection/pneumonia (none of which were considered related to Testim® administration), mood swings and hypertension. No Testim® patients discontinued due to skin reaction.
In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse event. In the pivotal U.S. and European Phase 3 trials combined, at the 50 mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the 100 mg dose group, 2.3% and 2.8% of patients had a clinically notable increase in hemoglobin (≥ 19 gm/dL) or hematocrit (≥ 58%), respectively.
In the combined ongoing U.S. and European open label extension studies, approximately 140 patients received Testim® for at least 6 months. The preliminary results from these studies are consistent with those reported for the U.S. controlled clinical trial.
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