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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-4908 | Other Identifier | WHO | |
| 2009-017034-50 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial part 1 | Active Comparator |
| |
| Trial part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estradiol, 25 mcg | Drug | Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction | from dosing to day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events and local tolerability | from dosing to day 4 |
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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 |
|---|---|---|---|---|---|---|
| Mainz | 55127 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| estradiol, 25 mcg | Drug | Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A) |
|
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |