Table 4.
Menopausal symptoms reported at screening
| US Participants | EU Participants | |||||
|---|---|---|---|---|---|---|
| Dallas, TX (n = 9) | Chicago, IL (n = 7) | Total US (N = 16) | UK (n = 8) | France (n = 8) | Total EU (N = 16) | |
| Age at VMS onset, mean (SD), y | 46.2 (6.2) | 49.9 (5.3) | 47.8 (5.9) | 48.3 (4.4) | 48.9 (4.0) | 48.6 (4.1) |
| Average weekly number of moderate to severe VMS,a mean (SD) | ||||||
| Moderate | 34.1 (15.2) | 27.1 (13.9) | 30.9 (14.5) | 40.3 (19.0) | 25.0 (28.7) | 32.6 (24.8) |
| Severe | 27.2 (23.3) | 31.7 (27.7) | 29.2 (24.5) | 25.4 (22.7) | 44.1 (21.4) | 34.8 (23.4) |
| Other menopausal symptoms at screening,b n (%) | ||||||
| Problems sleeping | 8 (88.9) | 7 (100) | 15 (93.8) | 6 (75.0) | 6 (75.0) | 12 (75.0) |
| Mood swings | 6 (66.7) | 2 (28.6) | 8 (50.0) | 6 (75.0) | 6 (75.0) | 12 (75.0) |
| Weight gain | 7 (77.8) | 7 (100) | 14 (87.5) | 5 (62.5) | 6 (75.0) | 11 (68.8) |
| Vaginal dryness | 6 (66.7) | 4 (57.1) | 10 (62.5) | 4 (50.0) | 4 (50.0) | 8 (50.0) |
| Memory/concentration problems | 5 (55.6) | 3 (42.9) | 8 (50.0) | 7 (87.5) | 0 | 7 (43.8) |
| Headaches | 4 (44.4) | 3 (42.9) | 7 (43.8) | 5 (62.5) | 2 (25.0) | 7 (43.8) |
| Depression | 3 (33.3) | 1 (14.3) | 4 (25.0) | 1 (12.5) | 0 | 1 (6.3) |
VMS vasomotor symptoms
aParticipants were asked at screening, “In a typical week, how many hot flashes (including night sweats) do you have that are mild, moderate, or severe?” and were asked to provide the “number per typical week” for each severity level. Participants were provided with the following definitions: mild = sensation of heat without sweating; moderate = sensation of heat with sweating, but able to continue activity; severe = sensation of heat with sweating, causing cessation of activity
bParticipants were queried at screening as to whether they had each of the listed symptoms