Table 2.

Onset and Progression of Puberty for Patients in Pubertal Analysis Population

Pooled Treatment Group	Childhood Oral Placebo (n = 62)a	Childhood Low-Dose Estrogen (n = 61)a	P Valueb
Variable, y
Chronological age at study entry	7.22 (5.00–11.89)	7.93 (5.02–11.91)	.035
Bone age at study entry	6.00 (2.00–10.00)	6.83 (2.50–11.50)	.077
Age at transient Tanner breast stage ≥2	12.56 (5.95–14.36)	11.07 (6.14–15.39)	<.001
Age at sustained Tanner breast stage ≥2	12.62 (9.69–14.44)	11.64 (6.73–15.39)	<.001
Bone age at Tanner breast stage ≥2	12.00 (8.83–14.50)	10.00 (6.83–14.00)	.003
Age at Tanner breast stage ≥3	13.29 (10.44–15.69)	13.15 (8.70–15.90)	.086
Age at Tanner breast stage ≥4	14.00 (11.69–15.91)	14.27 (8.70–17.06)	.463
Age at Tanner breast stage 5	14.96 (11.69–16.62)	15.20 (11.63–17.05)	.997
Age at menarche	15.00 (11.00–16.00)	15.00 (10.40–17.00)	.986
Time from baseline to Tanner breast stage ≥2	5.08 (0.51–8.50)	1.95 (0.44–8.55)	.040
Time from baseline to menarche	7.20 (3.11–10.00)	5.58 (2.16–10.02)	.222
Time from Tanner breast stage ≥2 to menarche	2.16 (0.25–5.61)	3.33 (0.92–6.42)	.003
Time from Tanner breast stage ≥2 to Tanner breast stage 5	2.54 (0.49–4.03)	3.01 (1.51–6.59)	.104

Values are expressed as median (minimum-maximum) in years. Age at Tanner breast stage ≥2 reflects the fact that the precise timing of Tanner 2 was not observed for some girls, as the first recorded post-baseline stage was ≥B3; the analyses were performed in the same fashion for Tanner breast stages 3 and 4.

^aNumbers shown for pooled treatment groups are the maximum numbers; numbers of patients with data available at each specific stage are provided in the patient flow diagram (Supplemental Figure 1).

^bP values for baseline variables were obtained from ANOVA; P values for comparison of ages at specific stages were obtained from analysis of covariance with baseline age as covariate; P values for time to event variables were obtained from Cox regression models with baseline age as covariate.