Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women

Not Applicable

Recruiting

• Conditions: Vagina Atrophy
• Interventions: Drug: Vaginal estradiol tablets

• Registration Number: NCT07160504
• Lead Sponsor: University of Aarhus

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 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.

Study Timeline

• Study Start: 2025-03-21
• Status Verified: 2025-05
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaginal estrogen treatment	Vaginal estradiol tablets	-

Primary Outcome Measures

Name	Time	Method
Endogenous thrombin potential (ETP)	0 months, 3 months	nmol/l x min
Endogenous trombin lag time (LT)	0 months, 3 months	min
Endogenous trombin peak height	0 months, 3 months	nmol/l
Factor VIII (FVIII)	0 months, 3 months	Percentage
Antithrombin	0 months, 3 months	Percentage
Protein S	0 months, 3 months	Percentage
Protein C	0 months, 3 months	Percentage
D-dimer	0 months, 3 months	ng/mL
CRP	0 months, 3 months	mg/l
Fibrinogen	0 months, 3 months	g/l
Tissue-type plaminogen activator (t-PA)	0 months, 3 months	ng/mL
Plasminogen activator inhibitor type 1 (PAI-1)	0 months, 3 months	ng/mL
Faktor XII (FXII)	0 months, 3 months	μg/mL
Prekallikrein (PK)	0 months, 3 months	μg/mL
H-Kininogen (HK)	0 months, 3 months	Percentage
Cleaved H-Kininogen (cHK)	0 months, 3 months	μg/mL
C1-esterase inhibitor (C1-inh)	0 months, 3 months	g/L
Endogenous kallikrein potential (EKP)	0 months, 3 months	nmol/L x min

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark; 🇩🇰 Aarhus N, Denmark