Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women

Is There an Effect of Local Vaginal Estrogen Treatment on the 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.

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.

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