Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women

University of Aarhus

Status and phase: Enrolling; Phase 4

Conditions: Vagina Atrophy

Treatments: Drug: Vaginal estradiol tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT07160504

2024-519539-41-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Vaginal estrogen treatment

Other group

Treatment:

Drug: Vaginal estradiol tablets