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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519539-41-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
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This study investigates whether vaginal estrogen treatment has an effect on hemostatic parameters in postmenopausal women. Blood samples are collected before and after 3 months treatment to assess changes in hemostasis.
This prospective cohort study includes 90 postmenopausal women aged ≥ 50, having vaginal atrophy symptoms and indication for treatment with vaginal estrogen tablets 10 µg at least 3 times a week for 3 months. Participants are divided into 2 study populations. Study population 1: 45 without a history of venous thromboembolic event and study population 2: 45 with a history of venous thromboembolic event.
Participation will involve 2 visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal estrogen treatment | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal estradiol tablets | Drug | Vaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic). |
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| Measure | Description | Time Frame |
|---|---|---|
| Endogenous thrombin potential (ETP) | nmol/l x min | 0 months, 3 months |
| Endogenous trombin lag time (LT) | min | 0 months, 3 months |
| Endogenous trombin peak height | nmol/l | 0 months, 3 months |
| Factor VIII (FVIII) | Percentage | 0 months, 3 months |
| Antithrombin | Percentage | 0 months, 3 months |
| Protein S | Percentage | 0 months, 3 months |
| Protein C | Percentage | 0 months, 3 months |
| D-dimer | ng/mL | 0 months, 3 months |
| CRP | mg/l | 0 months, 3 months |
| Fibrinogen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pinar Bor, Pinar Bor, MD, PhD, Prof. | Contact | +45 78 42 11 13 | isipinbo@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark | Recruiting | Aarhus N | 8200 | Denmark |
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g/l
| 0 months, 3 months |
| Tissue-type plaminogen activator (t-PA) | ng/mL | 0 months, 3 months |
| Plasminogen activator inhibitor type 1 (PAI-1) | ng/mL | 0 months, 3 months |
| Faktor XII (FXII) | μg/mL | 0 months, 3 months |
| Prekallikrein (PK) | μg/mL | 0 months, 3 months |
| H-Kininogen (HK) | Percentage | 0 months, 3 months |
| Cleaved H-Kininogen (cHK) | μg/mL | 0 months, 3 months |
| C1-esterase inhibitor (C1-inh) | g/L | 0 months, 3 months |
| Endogenous kallikrein potential (EKP) | nmol/L x min | 0 months, 3 months |