Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00820664 | A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women | PHASE1 | COMPLETED | 29 | — | — | Dec 1, 2008 | May 1, 2009 | Jan 22, 2016 | - | — |
Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply.
| Arm | Type | Description |
|---|---|---|
| 17β-estradiol 2.0 milligrams | ACTIVE_COMPARATOR | Estrace 2.0 mg tablet |
| 17β-estradiol 0.5 milligrams | ACTIVE_COMPARATOR | Estrace 0.5 mg tablet |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Comparator: Estrace 0.5 mg | DRUG | 0.5 mg tablet taken once daily for 28 days |
| Comparator: Estrace 2 mg | DRUG | 2 mg tablets taken once daily for 28 days. |
| Comparator: Placebo | DRUG | Placebo 0 mg capsule taken once daily for 28 days |
Inclusion Criteria: * Patient is a healthy postmenopausal woman less than or equal to 65 years of age with onset of menopause less than or equal to 10 years prior to prestudy visit 1 * Patient has a uterus and no history of uterine bleeding in the past 3 months * Patient has not had a previous endo...