Table 2.

Endometrial biopsy findings by treatment group in intention to treat and per protocol populations

	Intention to treat population (198 women)			Per protocol population (163 women)
	Oral E2 plus Vaginal P4 (134 women)	Placebo (64 women)	Proportion Difference	Oral E2 plus Vaginal P4 (111 women)	Placebo (52 women)	Proportion Difference
Endometrial malignancy or hyperplasia	17, 12.7% (7.6%, 19.5%)	2, 3.1% (0.4%, 10.8%)	9.6% (2.5%, 16.6%)	15, 13.5% (7.8%, 21.3%)	1, 1.9% (0%, 10.3%)	11.6% (4.2%, 19.0%)
Endometrial malignancy	1, 0.7% (0%, 4.1%)	2, 3.1% (0.4%, 10.8%)	−2.4% (−6.9%, 2.1%)	0, 0% (0%, 3.3%)	1, 1.9% (0%, 10.3%)	−1.9% (−5.7%, 1.8%)
Complex hyperplasia with atypia	4, 3.0% (0.8%, 7.5%)	0, 0% (0%, 5.6%)	3.0% (0.1%, 5.9%)	4, 3.6% (1.0%, 9.0%)	0, 0% (0%, 6.8%)	3.6% (0.1%, 7.1%)
Simple hyperplasia with atypia	1, 0.7% (0%, 4.1%)	0, 0% (0%, 5.6%)	0.7% (−0.7%, 2.2%)	1, 0.9% (0%, 4.9%)	0, 0% (0%, 6.8%)	0.9% (−0.9%, 2.7%)
Complex hyperplasia without atypia	7, 5.2% (2.1%, 10.5%)	0, 0% (0%, 5.6%)	5.2% (1.5%, 9.0%)	6, 5.4% (2.0%, 11.4%)	0, 0% (0%, 6.8%)	5.4% (1.2%, 9.6%)
Simple hyperplasia without atypia	4, 3.0% (0.8%, 7.5%)	0, 0% (0%, 5.6%)	3.0% (0.1%, 5.9%)	4, 3.6% (1.0%, 9.0%)	0, 0% (0%, 6.8%)	3.6% (0.1%, 7.1%)
Secretory endometrium	2, 1.5% (0.2%, 5.3%)	1, 1.6% (0%, 8.4%)	−0.1% (−3.7%, 3.6%)	2, 1.8% (0.2%, 6.4%)	1, 1.9% (0%, 10.3%)	−0.1% (−4.6%, 4.4%)
Proliferative endometrium	96, 71.6% (63.2%, 79.1%)	7, 10.9% (4.5%, 21.2%)	60.7% (49.9%, 71.5%)	79, 71.2% (61.8%, 79.4%)	6, 11.5% (4.3%, 23.4%)	59.6% (47.5%, 71.7%)
Atrophic endometrium	37, 27.6% (20.2%, 36.0%)	26, 40.6% (28.5%, 53.6%)	−13.0% (−27.2%, 1.2%)	27, 24.3% (16.7%, 33.4%)	22, 42.3% (28.7%, 56.8%)	−18.0% (−33.6%, −2.4%)
Other benign results	65, 48.5% (39.8%, 57.3%)	41, 64.1% (51.1%, 75.7%)	−15.6% (−30.0%, 1.1%)	48, 43.2% (33.9%, 53.0%)	32, 61.5% (47.0%, 74.7%)	−18.3% (−34.4%, −2.2%)

Data reported as number of women, proportion, 95%confidence interval of proportion

E2=estradiol, P4=progesterone