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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1112-8626 | Other Identifier | WHO |
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This study is conducted in Europe. The primary aim of this observational study is to investigate the occurrence of bleeding in women taking 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) | Drug | Data collection of the use of 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) in women in connection to a daily clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding profile during the 52 weeks of treatment with 0.5 mg estradiol and 0.1 mg norethisterone acetate evaluated by bleeding, and bleeding or spotting rates | At every lunar month (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bleeding profile | During the 52 weeks of treatment | |
| Change in mean number of hot flushes per week | During the 52 weeks of treatment |
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Inclusion Criteria:
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The postmenopausal women (who are ammenorrheic) are to be offered participation in the study at the discretion of the treating physician following the decision to prescribe 0.5 mg estradiol and 0.1 mg norethisterone acetate for the treatment of their menopausal symptoms.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rud | 1309 | Norway | ||||
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Gothenburg |
| 416 85 |
| Sweden |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D000077563 | Norethindrone Acetate |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009640 | Norethindrone |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
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