Table 3.
Cervical cytology findings by treatment group in intention to treat and per protocol populations
| Intention to treat population (517 women) | Per protocol population (517 women) | |||||
|---|---|---|---|---|---|---|
| Oral E2 plus Vaginal P4 (258 women) | Placebo (259 women) | Proportion Difference | Oral E2 plus Vaginal P4 (258 women) | Placebo (259 women) | Proportion Difference | |
| Total abnormal cervical cytology | 51, 19.8% (15.1%, 25.2%) | 45, 17.4% (13.0%, 22.5%) | 2.4% (−4.3%, 9.1%) | 35, 13.6% (9.6%, 18.4%) | 36, 13.9% (9.9%, 18.7%) | −0.3% (−6.2%, 5.6%) |
| Atypical squamous cells of undetermined significance | 37, 14.3% (10.3%, 19.2%) | 35, 13.5% (9.6%, 18.3%) | 0.8% (−5.1%, 6.8%) | 28, 10.8% (7.3%, 15.2%) | 28, 10.8% (7.3%, 15.2%) | 0% (−5.3%, 5.3%) |
| Atypical squamous cells cannot rule out high grade squamous intraepithelial cells | 3, 1.2% (0.2%, 3.4%) | 3, 1.2% (0.2%, 3.4%) | 0% (−1.8%, 1.8%) | 1, 0.4% (0%, 2.1%) | 3, 1.1% (0.2%, 3.3%) | −0.8% (−2.3%, 0.7%) |
| Low grade squamous intraepithelial lesion | 3, 1.2% (0.2%, 3.4%) | 0, 0% (0%, 1.4%) | 1.2% (−0.1%, 2.5%) | 2, 0.8, (0%, 2.8%) | 0, 0% (0%, 1.4%) | 0.7% (−0.3%, 1.8%) |
| High grade squamous intraepithelial lesion | 3, 1.2% (0.2%, 3.4%) | 6, 2.3% (0.9%, 5.0%) | −1.1% (−3.4%, 1.1%) | 1, 0.4% (0%, 2.1%) | 4, 1.5% (0.4%, 3.9%) | −1.1% (−2.8%, 0.5%) |
| Atypical endocervical glandular cells of undetermined significance | 9, 3.5% (1.6%, 6.5%) | 2, 0.8% (0%, 2.8%) | 2.7% (0.2%, 5.2%) | 7, 2.7% (1.1%, 5.5%) | 2, 0.8% (0%, 2.8%) | 1.9% (−0.3%, 4.2%) |
Data reported as number of women, proportion, 95%confidence interval of proportion
E2=estradiol, P4=progesterone