Overview
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.
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.
Eligibility
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