NCT07160504

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?

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vagina Atrophy

Interventions

Type	Name	Description
DRUG	Vaginal estradiol tablets	Vaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic).

Timeline

• Start date: 2025-03-21
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Denmark