Baseline Data for PPCOS I Subjects for Whom Stored Sera Were Available (n = 540)
| Variable . | . |
|---|---|
| Age, y | 28.07 (3.98) |
| BMI, kg/m2 | 35.29 (8.66) |
| ≥35 | 270 (50) |
| 30–34.99 | 118 (22) |
| <30 | 152 (28) |
| Parity | |
| 0 | 362 (67) |
| 1 | 178 (37) |
| Race | |
| White | 372 (69) |
| Black | 88 (16) |
| Asian | 16 (2.97) |
| American Indian | 61 (11.34) |
| Native Hawaiian | 1 (0.19) |
| Ethnicity | |
| Hispanic | 148 (27.41) |
| Non-Hispanic | 392 (72.59) |
| Hirsutisma | |
| Yes | 436 (81) |
| No | 104 (19) |
| Ovulatory dysfunctionb | |
| Yes | 415 (77) |
| No | 125 (23) |
| Smoking history | |
| Yes | 205 (38) |
| No | 335 (62) |
| Baseline TT, ng/dL | 61.72 (27.74) |
| Baseline SHBG, nmol/L | 29.53 (18.24) |
| Baseline FAIc | 9.51 (6.45) |
| Baseline HOMAd | 3.52 (1.90–6.15) |
| Baseline GIR | 5.38 (3.24–8.48) |
| Baseline creatinine | 0.76 (0.13) |
| Serum 25OHD, ng/mLe | 23.56 (9.88) |
| Categories of VitD, ng/mL | |
| <10e | 42 (8) |
| 10–19.99e | 143 (27) |
| 20–29.99e | 207 (38) |
| ≥30e | 148 (27) |
| Serum 25OHD >45 ng/mLe | |
| Yes | 10 (2) |
| No | 530 (98) |
| Study drug allocation | |
| CC alone | 175 (32) |
| CC+M | 183 (34) |
| M alone | 182 (34) |
| LB | 102 (19) |
| OVf | 402 (74) |
| PL | 42 (29) |
| Days in study | 180.70 (66.21) |
| Cycles to OV | 2.45 (1.87) |
| 1 | 235 (43) |
| 2 | 142 (26) |
| 3 | 39 (7) |
| 4 | 37 (7) |
| 5 | 13 (2) |
| 6 | 46 (8) |
| 7g | 26 (5) |
| 8g | 2 (0.4) |
| > two cycles to OV | |
| Yes | 163 (30) |
| No | 377 (70) |
| Variable . | . |
|---|---|
| Age, y | 28.07 (3.98) |
| BMI, kg/m2 | 35.29 (8.66) |
| ≥35 | 270 (50) |
| 30–34.99 | 118 (22) |
| <30 | 152 (28) |
| Parity | |
| 0 | 362 (67) |
| 1 | 178 (37) |
| Race | |
| White | 372 (69) |
| Black | 88 (16) |
| Asian | 16 (2.97) |
| American Indian | 61 (11.34) |
| Native Hawaiian | 1 (0.19) |
| Ethnicity | |
| Hispanic | 148 (27.41) |
| Non-Hispanic | 392 (72.59) |
| Hirsutisma | |
| Yes | 436 (81) |
| No | 104 (19) |
| Ovulatory dysfunctionb | |
| Yes | 415 (77) |
| No | 125 (23) |
| Smoking history | |
| Yes | 205 (38) |
| No | 335 (62) |
| Baseline TT, ng/dL | 61.72 (27.74) |
| Baseline SHBG, nmol/L | 29.53 (18.24) |
| Baseline FAIc | 9.51 (6.45) |
| Baseline HOMAd | 3.52 (1.90–6.15) |
| Baseline GIR | 5.38 (3.24–8.48) |
| Baseline creatinine | 0.76 (0.13) |
| Serum 25OHD, ng/mLe | 23.56 (9.88) |
| Categories of VitD, ng/mL | |
| <10e | 42 (8) |
| 10–19.99e | 143 (27) |
| 20–29.99e | 207 (38) |
| ≥30e | 148 (27) |
| Serum 25OHD >45 ng/mLe | |
| Yes | 10 (2) |
| No | 530 (98) |
| Study drug allocation | |
| CC alone | 175 (32) |
| CC+M | 183 (34) |
| M alone | 182 (34) |
| LB | 102 (19) |
| OVf | 402 (74) |
| PL | 42 (29) |
| Days in study | 180.70 (66.21) |
| Cycles to OV | 2.45 (1.87) |
| 1 | 235 (43) |
| 2 | 142 (26) |
| 3 | 39 (7) |
| 4 | 37 (7) |
| 5 | 13 (2) |
| 6 | 46 (8) |
| 7g | 26 (5) |
| 8g | 2 (0.4) |
| > two cycles to OV | |
| Yes | 163 (30) |
| No | 377 (70) |
Continuous data are presented as mean (standard deviation) or median (interquartile range), and categorical data are presented as number (percentage).
Ferriman-Gallwey score ≥8.
Ovulatory dysfunction as attributable cause for infertility.
FAI: TT (nmol/L)/SHBG (nmol/L) × 100.
HOMA-IR: glucose (mg/dL) × insulin (μIU/mL)/405.
Multiply by 2.5 for conversion to SI units (nmol/L).
Ovulation achieved during the course of the trial.
Maximum of six treatment cycles over a 30-week period.
Baseline Data for PPCOS I Subjects for Whom Stored Sera Were Available (n = 540)
| Variable . | . |
|---|---|
| Age, y | 28.07 (3.98) |
| BMI, kg/m2 | 35.29 (8.66) |
| ≥35 | 270 (50) |
| 30–34.99 | 118 (22) |
| <30 | 152 (28) |
| Parity | |
| 0 | 362 (67) |
| 1 | 178 (37) |
| Race | |
| White | 372 (69) |
| Black | 88 (16) |
| Asian | 16 (2.97) |
| American Indian | 61 (11.34) |
| Native Hawaiian | 1 (0.19) |
| Ethnicity | |
| Hispanic | 148 (27.41) |
| Non-Hispanic | 392 (72.59) |
| Hirsutisma | |
| Yes | 436 (81) |
| No | 104 (19) |
| Ovulatory dysfunctionb | |
| Yes | 415 (77) |
| No | 125 (23) |
| Smoking history | |
| Yes | 205 (38) |
| No | 335 (62) |
| Baseline TT, ng/dL | 61.72 (27.74) |
| Baseline SHBG, nmol/L | 29.53 (18.24) |
| Baseline FAIc | 9.51 (6.45) |
| Baseline HOMAd | 3.52 (1.90–6.15) |
| Baseline GIR | 5.38 (3.24–8.48) |
| Baseline creatinine | 0.76 (0.13) |
| Serum 25OHD, ng/mLe | 23.56 (9.88) |
| Categories of VitD, ng/mL | |
| <10e | 42 (8) |
| 10–19.99e | 143 (27) |
| 20–29.99e | 207 (38) |
| ≥30e | 148 (27) |
| Serum 25OHD >45 ng/mLe | |
| Yes | 10 (2) |
| No | 530 (98) |
| Study drug allocation | |
| CC alone | 175 (32) |
| CC+M | 183 (34) |
| M alone | 182 (34) |
| LB | 102 (19) |
| OVf | 402 (74) |
| PL | 42 (29) |
| Days in study | 180.70 (66.21) |
| Cycles to OV | 2.45 (1.87) |
| 1 | 235 (43) |
| 2 | 142 (26) |
| 3 | 39 (7) |
| 4 | 37 (7) |
| 5 | 13 (2) |
| 6 | 46 (8) |
| 7g | 26 (5) |
| 8g | 2 (0.4) |
| > two cycles to OV | |
| Yes | 163 (30) |
| No | 377 (70) |
| Variable . | . |
|---|---|
| Age, y | 28.07 (3.98) |
| BMI, kg/m2 | 35.29 (8.66) |
| ≥35 | 270 (50) |
| 30–34.99 | 118 (22) |
| <30 | 152 (28) |
| Parity | |
| 0 | 362 (67) |
| 1 | 178 (37) |
| Race | |
| White | 372 (69) |
| Black | 88 (16) |
| Asian | 16 (2.97) |
| American Indian | 61 (11.34) |
| Native Hawaiian | 1 (0.19) |
| Ethnicity | |
| Hispanic | 148 (27.41) |
| Non-Hispanic | 392 (72.59) |
| Hirsutisma | |
| Yes | 436 (81) |
| No | 104 (19) |
| Ovulatory dysfunctionb | |
| Yes | 415 (77) |
| No | 125 (23) |
| Smoking history | |
| Yes | 205 (38) |
| No | 335 (62) |
| Baseline TT, ng/dL | 61.72 (27.74) |
| Baseline SHBG, nmol/L | 29.53 (18.24) |
| Baseline FAIc | 9.51 (6.45) |
| Baseline HOMAd | 3.52 (1.90–6.15) |
| Baseline GIR | 5.38 (3.24–8.48) |
| Baseline creatinine | 0.76 (0.13) |
| Serum 25OHD, ng/mLe | 23.56 (9.88) |
| Categories of VitD, ng/mL | |
| <10e | 42 (8) |
| 10–19.99e | 143 (27) |
| 20–29.99e | 207 (38) |
| ≥30e | 148 (27) |
| Serum 25OHD >45 ng/mLe | |
| Yes | 10 (2) |
| No | 530 (98) |
| Study drug allocation | |
| CC alone | 175 (32) |
| CC+M | 183 (34) |
| M alone | 182 (34) |
| LB | 102 (19) |
| OVf | 402 (74) |
| PL | 42 (29) |
| Days in study | 180.70 (66.21) |
| Cycles to OV | 2.45 (1.87) |
| 1 | 235 (43) |
| 2 | 142 (26) |
| 3 | 39 (7) |
| 4 | 37 (7) |
| 5 | 13 (2) |
| 6 | 46 (8) |
| 7g | 26 (5) |
| 8g | 2 (0.4) |
| > two cycles to OV | |
| Yes | 163 (30) |
| No | 377 (70) |
Continuous data are presented as mean (standard deviation) or median (interquartile range), and categorical data are presented as number (percentage).
Ferriman-Gallwey score ≥8.
Ovulatory dysfunction as attributable cause for infertility.
FAI: TT (nmol/L)/SHBG (nmol/L) × 100.
HOMA-IR: glucose (mg/dL) × insulin (μIU/mL)/405.
Multiply by 2.5 for conversion to SI units (nmol/L).
Ovulation achieved during the course of the trial.
Maximum of six treatment cycles over a 30-week period.
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