Status:

RECRUITING

Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women

Lead Sponsor:

University of Aarhus

Collaborating Sponsors:

University of Southern Denmark

Conditions:

Vagina Atrophy

Eligibility:

FEMALE

50+ years

Phase:

PHASE4

Brief 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 cha...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 21 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT07160504

Start Date

March 21 2025

End Date

December 31 2026

Last Update

September 8 2025

Active Locations (1)

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Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark

Aarhus N, Denmark, 8200