Vagina Atrophy
Conditions
Keywords
Postmenopausal, Hemostasis, Venous thromboembolic event
Brief summary
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.
Detailed description
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: * First visit: prior the initiation of treatment an interview is carried out to assess inclusion criteria and information on demographics followed by blood sampling. * Second visit: follow-up blood sampling after three months treatment. Hemostatic parameters will be assessed, comparing the blood samples at baseline with the follow-up blood sample.
Interventions
Vaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic).
Sponsors
University of Southern Denmark
University of Aarhus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women aged ≥ 50 * Symptomatic vaginal atrophy * Indication for standard treatment with vaginal estrogen tablets 10 µg at least three times a week * Study population 1: without a history of venous thromboembolic event * Study population 2: with a history of venous thromboembolic event
Exclusion criteria
* Unable to give written informed consent * Does not speak Danish * Current cancer treatment * Current treatment with blood thinning medication (except plateletinhibitor) * Current treatment with local or systematic estrogen * Systemic inflammatory disease, liver disease or kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endogenous thrombin potential (ETP) | 0 months, 3 months | nmol/l x min |
| Endogenous trombin lag time (LT) | 0 months, 3 months | min |
| Endogenous trombin peak height | 0 months, 3 months | nmol/l |
| Factor VIII (FVIII) | 0 months, 3 months | Percentage |
| Antithrombin | 0 months, 3 months | Percentage |
| Protein S | 0 months, 3 months | Percentage |
| Protein C | 0 months, 3 months | Percentage |
| D-dimer | 0 months, 3 months | ng/mL |
| CRP | 0 months, 3 months | mg/l |
| Fibrinogen | 0 months, 3 months | g/l |
| Tissue-type plaminogen activator (t-PA) | 0 months, 3 months | ng/mL |
| Plasminogen activator inhibitor type 1 (PAI-1) | 0 months, 3 months | ng/mL |
| Faktor XII (FXII) | 0 months, 3 months | μg/mL |
| Prekallikrein (PK) | 0 months, 3 months | μg/mL |
| H-Kininogen (HK) | 0 months, 3 months | Percentage |
| Cleaved H-Kininogen (cHK) | 0 months, 3 months | μg/mL |
| C1-esterase inhibitor (C1-inh) | 0 months, 3 months | g/L |
| Endogenous kallikrein potential (EKP) | 0 months, 3 months | nmol/L x min |
Countries
Denmark
Contacts
Primary ContactPinar Bor, Pinar Bor, MD, PhD, Prof.
Outcome results
None listed