Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-21

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Vagina Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vaginal estrogen treatment

Group Type OTHER

Vaginal estradiol tablets

Intervention Type DRUG

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

Interventions

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Vaginal estradiol tablets

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No