Table 2.
Incidence of adverse events in the intention-to-treat population.
| Testosterone (n = 24) |
Placebo (n = 26) |
|||||
|---|---|---|---|---|---|---|
| Phase 1 | Phase 2 | Phase 3 | Phase 1 | Phase 2 | Phase 3 | |
| Death | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious adverse event | ||||||
| Low absolute neutrophil count | 0 | 0 | 0 | 1 | 0 | 0 |
| Elevated alanine aminotransferase | 0 | 0 | 3 | 0 | 0 | 0 |
| Biopsy infection, cellulitis | 0 | 1 | 0 | 0 | 0 | 0 |
| Adverse event-related withdrawals | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse event | ||||||
| Biopsy pain | 20 | 20 | 0 | 17 | 23 | 2 |
| Blister/chafing | 0 | 8 | 1 | 0 | 7 | 1 |
| Foot pain | 0 | 7 | 0 | 0 | 7 | 0 |
| Joint/muscle soreness | 3 | 28 | 0 | 2 | 26 | 0 |
| Gastrointestinal | 1 | 5 | 1 | 0 | 5 | 1 |
| Dermatological | 1 | 5 | 1 | 3 | 10 | 0 |
| Insomnia | 0 | 9 | 0 | 0 | 7 | 0 |
| Headache | 2 | 4 | 3 | 0 | 2 | 3 |
| Allergy/eye irritation/ear pain | 3 | 2 | 3 | 4 | 5 | 0 |
| Low haemoglobin, haematocrit, and mean cell volume | 0 | 1 | 0 | 0 | 0 | 0 |
| Iron deficiency anaemia | 0 | 0 | 0 | 0 | 1 | 0 |
| Other1 | 1 | 4 | 0 | 2 | 2 | 1 |
Chi square tests were used to compare adverse event incidence in Testosterone (n = 24) and Placebo (n = 26) within each phase. There were no between group differences during any phase (P > .05). Percutaneous muscle biopsies of the vastus lateralis were obtained during P1 and P2. P1 = phase 1, P2 = phase 2, P3 = phase 3, Testosterone = 55% energy deficit + 200 mg testosterone enanthate per week during Phase 2, Placebo = 55% energy deficit + 1 mL sesame seed oil placebo per week during Phase 2. 1Other: Testosterone; P1, vasovagal/syncope (n = 1); P2, vasovagal/syncope (n = 1), fatigue (n = 1), blurred vision (n = 1), herpes simplex (n = 1); Placebo; P1, chest pain (n = 1), vertigo (n = 1); P2, vertigo (n = 1), dysuria (n = 1); P3, visual disturbance (n = 1).