Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark
Aarhus N, 8200, Denmark
Location status: Recruiting
Recruiting
NCT Number: NCT07160504
Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
50 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Vaginal estradiol tablets
DrugVaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic).
Primary outcomes
-
Endogenous thrombin potential (ETP)
Time frame: 0 months, 3 months
nmol/l x min
-
Endogenous trombin lag time (LT)
Time frame: 0 months, 3 months
min
-
Endogenous trombin peak height
Time frame: 0 months, 3 months
nmol/l
-
Factor VIII (FVIII)
Time frame: 0 months, 3 months
Percentage
-
Antithrombin
Time frame: 0 months, 3 months
Percentage
-
Protein S
Time frame: 0 months, 3 months
Percentage
-
Protein C
Time frame: 0 months, 3 months
Percentage
-
D-dimer
Time frame: 0 months, 3 months
ng/mL
-
CRP
Time frame: 0 months, 3 months
mg/l
-
Fibrinogen
Time frame: 0 months, 3 months
g/l
-
Tissue-type plaminogen activator (t-PA)
Time frame: 0 months, 3 months
ng/mL
-
Plasminogen activator inhibitor type 1 (PAI-1)
Time frame: 0 months, 3 months
ng/mL
-
Faktor XII (FXII)
Time frame: 0 months, 3 months
μg/mL
-
Prekallikrein (PK)
Time frame: 0 months, 3 months
μg/mL
-
H-Kininogen (HK)
Time frame: 0 months, 3 months
Percentage
-
Cleaved H-Kininogen (cHK)
Time frame: 0 months, 3 months
μg/mL
-
C1-esterase inhibitor (C1-inh)
Time frame: 0 months, 3 months
g/L
-
Endogenous kallikrein potential (EKP)
Time frame: 0 months, 3 months
nmol/L x min
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Aarhus
Other
Collaborators
- University of Southern Denmark
Registry information
Official study title
Is There an Effect of Local Vaginal Estrogen Treatment on the Hemostatic Parameters in Postmenopausal Women?
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Sep 8, 2025
- Registry last updated
- Sep 8, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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