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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002457-32 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) | Drug | A single oral dose of 2 tablets under fasting conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC(0-∞)) | ||
| Maximal concentration (Cmax) | ||
| Time to maximum (tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) from dosing up to last sample | ||
| Terminal half-life (t½) |
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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 |
|---|---|---|---|---|---|---|
| Neu-Ulm | 89231 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) | Drug | A single oral dose of 2 tablets under fasting conditions |
|
| 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA) | Drug | A single oral dose of 1 tablet under fasting conditions |
|
| 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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