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This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| estradiol / norethisterone acetate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) | Drug | After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®. |
| Measure | Description | Time Frame |
|---|---|---|
| Postmenopausal women's acceptance of bleeding | After 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding profile in postmenopausal women | After 24 weeks of treatment | |
| Acceptance of hot flushes and breast tenderness | After 24 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Kristiansand | Norway | ||||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| Kristiansund |
| Norway |
| Novo Nordisk Investigational Site | Larvik | Norway |
| Novo Nordisk Investigational Site | Oslo | 0309 | Norway |
| Novo Nordisk Investigational Site | Trondheim | NO-7012 | Norway |
| Novo Nordisk Investigational Site | Borås | 503 32 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 411 19 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 418 33 | Sweden |
| Novo Nordisk Investigational Site | Kungsbacka | 434 30 | Sweden |
| Novo Nordisk Investigational Site | Linköping | 581 85 | Sweden |
| Novo Nordisk Investigational Site | Linköping | 582 20 | Sweden |
| Novo Nordisk Investigational Site | Linköping | 582 22 | Sweden |
| Novo Nordisk Investigational Site | Norrköping | 602 22 | Sweden |
| Novo Nordisk Investigational Site | Norrköping | 602 32 | Sweden |
| Novo Nordisk Investigational Site | Sigtuna | 193 30 | Sweden |
| Novo Nordisk Investigational Site | Södertälje | 151 23 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 111 37 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 111 57 | Sweden |
| Novo Nordisk Investigational Site | Uddevalla | 451 30 | 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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