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This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estradiol, 25 mcg | Drug | Vaginal tablets for 6-12 weeks according to product labelling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently' | ||
| Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events |
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Inclusion Criteria:
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Women with atrophic vaginitis caused by estrogen deficiency prescribed with Vagifem® by their treating physician
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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 | Mainz | 55127 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Stute P. Urogenitale Beschwerden und Östradioltherapie: Auswirkung einer vaginalen niedrig dosierten Östradioltherapie auf die Prävalenz und Intensität von urogenitalen Beschwerden. Gynäkologische Endokrinologie 2008; 6 (1): 48-52 |
| 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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| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |