| Period |
Screening/Run-in |
Treatment |
Follow-up |
| Visit |
0 |
Baseline |
2 |
3 |
4 |
| Day |
-30 to -1 |
0 |
31 |
92 |
120 |
Medical History |
X |
|
|
|
|
| Menopausal Symptoms |
X |
X |
X |
X |
X |
| Vital Signs |
X |
X |
X |
X |
X |
| Physical Examination |
X |
|
|
|
|
| Review of Incl./Excl. Criteria Study |
X |
|
|
|
|
| Informed Consent |
X |
|
|
|
|
| Urinalysis |
X |
|
X |
X |
X |
| Concomitant Medications |
X |
X |
X |
X |
X |
| Randomization |
|
X |
|
|
|
| Hormone assay |
X |
|
X |
X |
X |
| Hematology |
X |
|
X |
X |
X |
| Biochemistry |
X |
|
X |
X |
X |
| Pelvic Ultrasound Endometrial Sampling/Hysteroscopy |
X |
|
|
|
|
| Vaginal Maturation |
X |
|
|
X |
X |
| Body Mass Index (kg/m2) |
|
X |
X |
X |
X |
| Greene Scale |
X |
X |
X |
X |
X |
| MENQOL |
X |
X |
X |
X |
X |
| Dispense Study Medication |
|
X |
X |
|
|
| Medication Accountability |
|
|
X |
X |
|
| Record Adverse Event |
|
|
X |
X |
|
|
