Table 3.
Endpoint | Placebo (N=26) | Testosterone (N=25) | p-value |
---|---|---|---|
Change in BPI-AIA Average Pain Score from Baseline to Month 1 | −0.8 (−1.6,−0.1) | −2.0 (−2.8,−1.2) | 0.04 |
Percent of Baseline Hot Flash Frequency at Week 8 | 59.9% (44%,76%) | 35.8% (20%,52%) | 0.03 |
Percent of Baseline Hot Flash Scores at Week 8 | 48.1% (35%,61%) | 28.1% (15%,41%) | 0.03 |
Maximum SED Nausea at Month 3 | 3.0 (1.8,4.1) | 1.1 (0.5,1.7) | 0.02 |
Maximum SED Fatigue at Month 3 | 7.0 (5.9,8.0) | 5.3 (4.2,6.5) | 0.04 |
Maximum SED Mood Swings at Month 3 | 5.4 (4.2,6.7) | 3.5 (2.3,4.7) | 0.03 |
Maximum SED Hand or Feet Swelling at Month 3 | 4.2 (2.9,5.5) | 1.7 (0.8,2.6) | 0.01 |
MENQOL Incidence of Stress Urinary Incontinence at Month 3 | 42% (22%,63%) | 10% (1%,32%) | 0.04 |
MENQOL Incidence of Changes in Appearance, Texture or Tone of Skin at Month 3 |
46% (26%,67%) | 10% (1%,29%) | 0.01 |
BPI-AIA = Modified Brief Pain Inventory for Aromatase Inhibitor Arthralgia
SED = Symptom Experience Diary
MENQOL = Menopause Specific Quality of Life Questionnaire