| Period |
Screening |
Treatment |
| Visit |
0 |
Baseline |
2 |
3 |
| Day |
-30 to -1 |
0 |
91 |
182 |
| Medical History |
X |
X |
X |
X |
| Menopausal Symptoms |
X |
X |
X |
X |
| Vital Signs |
X |
X |
X |
X |
| Physical Examination |
X |
|
|
|
| Review of Incl./Excl. Criteria Study |
X |
|
|
|
| Informed Consent |
X |
|
|
|
| Urinalysis |
X |
|
X |
X |
| Concomitant Medications |
X |
X |
X |
X |
| Randomization |
|
X |
|
|
| Hormone assay |
X |
|
X |
X |
| Hematology |
X |
|
X |
X |
| Biochemistry |
X |
|
X |
X |
| Pelvic Ultrasound Endometrial Sampling/ Hysteroscopy |
X |
|
|
|
| Vaginal Maturation |
X |
|
|
X |
| Body Mass Index (kg/m2) |
|
X |
X |
X |
| Cardiovascular markers |
|
X |
X |
X |
| MENQOL |
|
X |
X |
X |
| Arterial Reactivity |
|
X |
X |
X |
| Dispense Study Medication |
|
X |
X |
|
| Medication Accountability |
|
|
X |
X |
| Record Adverse Event |
|
|
X |
X |
|
