Table 3.

Hormonal and bone age safety assessment

Before Treatment At BaselineAfter Treatment At Surgery
Hormonal safetyPlacebo N = 85Promestriene N = 84Placebo N = 85Promestriene N = 84
LH (UI/L)Mean (+/- SD)0.07 (±0.07)0.07 (±0.06)0.46 (±0.40)0.49 (±0.44)
FSH (UI/L)Mean (+/- SD)0.33 (±0.27)0.34 (±0.31)0.61 (±0.40)0.53 (±0.41)
AMH (pmol/L)Mean (±SD)1689 (±771)1703 (±758)1362 (±691)1511 (±717)
Estradiol (pmol/L)Mean (±SD)1.33 (±8.17)2.63 (±8.48)1.91 (±9.20)2.40 (±8.09)
Bone age safetyPlacebo N = 70Promestriene N = 67Placebo N = 70Promestriene N = 67
Estimated bone age (months)Mean (±SD)14.8 (±8.65)12.8 (±9.6)31.0 (±8.9)30.1 (±10.6)
Effective age (months)Mean (±SD)15.7(±5.2)15.8 (±5.1)30.4 (±5.3)30.7 (±5.7)
Before Treatment At BaselineAfter Treatment At Surgery
Hormonal safetyPlacebo N = 85Promestriene N = 84Placebo N = 85Promestriene N = 84
LH (UI/L)Mean (+/- SD)0.07 (±0.07)0.07 (±0.06)0.46 (±0.40)0.49 (±0.44)
FSH (UI/L)Mean (+/- SD)0.33 (±0.27)0.34 (±0.31)0.61 (±0.40)0.53 (±0.41)
AMH (pmol/L)Mean (±SD)1689 (±771)1703 (±758)1362 (±691)1511 (±717)
Estradiol (pmol/L)Mean (±SD)1.33 (±8.17)2.63 (±8.48)1.91 (±9.20)2.40 (±8.09)
Bone age safetyPlacebo N = 70Promestriene N = 67Placebo N = 70Promestriene N = 67
Estimated bone age (months)Mean (±SD)14.8 (±8.65)12.8 (±9.6)31.0 (±8.9)30.1 (±10.6)
Effective age (months)Mean (±SD)15.7(±5.2)15.8 (±5.1)30.4 (±5.3)30.7 (±5.7)
Table 3.

Hormonal and bone age safety assessment

Before Treatment At BaselineAfter Treatment At Surgery
Hormonal safetyPlacebo N = 85Promestriene N = 84Placebo N = 85Promestriene N = 84
LH (UI/L)Mean (+/- SD)0.07 (±0.07)0.07 (±0.06)0.46 (±0.40)0.49 (±0.44)
FSH (UI/L)Mean (+/- SD)0.33 (±0.27)0.34 (±0.31)0.61 (±0.40)0.53 (±0.41)
AMH (pmol/L)Mean (±SD)1689 (±771)1703 (±758)1362 (±691)1511 (±717)
Estradiol (pmol/L)Mean (±SD)1.33 (±8.17)2.63 (±8.48)1.91 (±9.20)2.40 (±8.09)
Bone age safetyPlacebo N = 70Promestriene N = 67Placebo N = 70Promestriene N = 67
Estimated bone age (months)Mean (±SD)14.8 (±8.65)12.8 (±9.6)31.0 (±8.9)30.1 (±10.6)
Effective age (months)Mean (±SD)15.7(±5.2)15.8 (±5.1)30.4 (±5.3)30.7 (±5.7)
Before Treatment At BaselineAfter Treatment At Surgery
Hormonal safetyPlacebo N = 85Promestriene N = 84Placebo N = 85Promestriene N = 84
LH (UI/L)Mean (+/- SD)0.07 (±0.07)0.07 (±0.06)0.46 (±0.40)0.49 (±0.44)
FSH (UI/L)Mean (+/- SD)0.33 (±0.27)0.34 (±0.31)0.61 (±0.40)0.53 (±0.41)
AMH (pmol/L)Mean (±SD)1689 (±771)1703 (±758)1362 (±691)1511 (±717)
Estradiol (pmol/L)Mean (±SD)1.33 (±8.17)2.63 (±8.48)1.91 (±9.20)2.40 (±8.09)
Bone age safetyPlacebo N = 70Promestriene N = 67Placebo N = 70Promestriene N = 67
Estimated bone age (months)Mean (±SD)14.8 (±8.65)12.8 (±9.6)31.0 (±8.9)30.1 (±10.6)
Effective age (months)Mean (±SD)15.7(±5.2)15.8 (±5.1)30.4 (±5.3)30.7 (±5.7)
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