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: * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
90
Vaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic).
Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark
Aarhus N, Denmark
RECRUITINGEndogenous thrombin potential (ETP)
nmol/l x min
Time frame: 0 months, 3 months
Endogenous trombin lag time (LT)
min
Time frame: 0 months, 3 months
Endogenous trombin peak height
nmol/l
Time frame: 0 months, 3 months
Factor VIII (FVIII)
Percentage
Time frame: 0 months, 3 months
Antithrombin
Percentage
Time frame: 0 months, 3 months
Protein S
Percentage
Time frame: 0 months, 3 months
Protein C
Percentage
Time frame: 0 months, 3 months
D-dimer
ng/mL
Time frame: 0 months, 3 months
CRP
mg/l
Time frame: 0 months, 3 months
Fibrinogen
g/l
Time frame: 0 months, 3 months
Tissue-type plaminogen activator (t-PA)
ng/mL
Time frame: 0 months, 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Plasminogen activator inhibitor type 1 (PAI-1)
ng/mL
Time frame: 0 months, 3 months
Faktor XII (FXII)
μg/mL
Time frame: 0 months, 3 months
Prekallikrein (PK)
μg/mL
Time frame: 0 months, 3 months
H-Kininogen (HK)
Percentage
Time frame: 0 months, 3 months
Cleaved H-Kininogen (cHK)
μg/mL
Time frame: 0 months, 3 months
C1-esterase inhibitor (C1-inh)
g/L
Time frame: 0 months, 3 months
Endogenous kallikrein potential (EKP)
nmol/L x min
Time frame: 0 months, 3 months