Table 2.
Demographic characteristics and baseline laboratory parameters of randomized patients
| Substudy participants (n = 312) | Substudy nonparticipants (n = 314) | All patients (n = 626) | P value across two patient populations | |
|---|---|---|---|---|
| Treatment | 0.46 | |||
| Clomiphene | 103 (33.0%) | 106 (33.8%) | 209 (33.4%) | |
| Metformin | 98 (31.4%) | 110 (35.0%) | 208 (33.2%) | |
| Combined | 111 (35.6%) | 98 (31.2%) | 209 (33.4%) | |
| Age | ||||
| n | 312 | 314 | 626 | 0.447 |
| Mean (sd) | 28.3 (4.0) | 27.9 (4.1) | 28.1 (4.0) | |
| BMI | ||||
| n | 312 | 313 | 625 | 0.896 |
| Mean (sd) | 35.3 (8.9) | 35.2 (8.4) | 35.2 (8.7) | |
| <30 kg/m2 | 90/312 (28.8%) | 89/313 (28.4%) | 179/625 (28.6%) | 0.993 |
| 30–34 kg/m2 | 67/312 (21.5%) | 68/313 (21.7%) | 135/625 (21.6%) | |
| ≥ 35 kg/m2 | 155/312 (49.7%) | 156/313 (49.8%) | 311/625 (49.8%) | |
| Hirsutism | ||||
| n | 312 | 314 | 626 | 0.152 |
| <8 | 65/312 (20.8%) | 56/314 (17.8%) | 121/626 (19.3%) | 0.136 |
| 8–16 | 138/312 (44.2%) | 124/314 (39.5%) | 262/626 (41.9%) | |
| ≥ 16 | 109/312 (34.9%) | 134/314 (42.7%) | 243/626 (38.8%) | |
| Ethnicity | ||||
| Not Hispanic or Latino | 234/312 (75.0%) | 228/314 (72.6%) | 462/626 (73.8%) | |
| Hispanic or Latino | 78/312 (25.0%) | 86/314 (27.4%) | 164/626 (26.2%) | 0.497 |
| Race | ||||
| White | 214/309 (69.3%) | 221/314 (70.4%) | 435/623 (69.8%) | 0.894 |
| Black or African American | 54/309 (17.5%) | 55/314 (17.5%) | 109/623 (17.5%) | |
| Asian | 8/309 (2.6%) | 9/314 (2.9%) | 17/623 (2.7%) | |
| American Indian or Alaska Native | 37/309 (12.0%) | 35/314 (11.1%) | 72/623 (11.6%) | |
| Native Hawaiian or Other Pacific Islander | 0 | 1/314 (0.3%) | 1/623 (0.2%) | |
| Previous study drug exposure | ||||
| None | 126/312 (40.4%) | 136/314 (43.3%) | 262/626 (41.9%) | 0.774 |
| Metformin only | 28/312 (9.0%) | 26/314 (8.3%) | 54/626 (8.6%) | |
| Clomiphene citrate only | 99/312 (31.7%) | 89/314 (28.3%) | 188/626 (30.0%) | |
| Metformin and clomiphene citrate | 59/312 (18.9%) | 63/314 (20.1%) | 122/626 (19.5%) | |
| Prior parity | 110/312 (35.3%) | 99/314 (31.5%) | 209/626 (33.4%) | 0.323 |
| Ultrasound | ||||
| PCO morphologya | 285/312 (91.3%) | 288/314 (91.7%) | 573/626 (91.5%) | 0.867 |
| Left ovarian volume (cm3) | ||||
| n | 312 | 314 | 626 | 0.308 |
| Mean (sd) | 10.8 (6.1) | 11.4 (6.7) | 11.1 (6.4) | |
| Right ovarian volume (cm3) | ||||
| n | 312 | 314 | 626 | 0.432 |
| Mean (sd) | 12.2 (6.9) | 11.9 (7.1) | 12.0 (7.0) | |
| Testosterone | ||||
| n | 304 | 304 | 608 | 0.063 |
| Mean (sd) | 64.2 (29.7) | 59.9 (27.4) | 62.0 (28.6) | |
| Bioavailable testosterone | ||||
| n | 304 | 304 | 608 | 0.926 |
| Mean (sd) | 9.6 (7.0) | 9.5 (6.5) | 9.5 (6.7) | |
| Glucose | ||||
| n | 306 | 302 | 608 | 0.036 |
| Mean (sd) | 90.6 (18.0) | 87.3 (16.6) | 89.0 (17.4) | |
| Insulin | ||||
| n | 306 | 304 | 610 | 0.648 |
| Mean (sd) | 24.1 (31.7) | 21.8 (20.3) | 23.0 (26.6) | |
| Proinsulin | ||||
| n | 305 | 304 | 609 | 0.757 |
| Mean (sd) | 25.2 (28.0) | 24.6 (23.5) | 24.9 (25.8) | |
| SHBG | ||||
| n | 306 | 304 | 610 | 0.116 |
| Mean (sd) | 30.8 (19.3) | 28.5 (16.7) | 29.7 (18.1) |
a
Either or both ovaries.