Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women

NCT07160504 | Recruiting Phase 4 DMC

• 1 other identifier: 2024-519539-41-00
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Vagina Atrophy

Keywords

Postmenopausal; Hemostasis; Venous thromboembolic event

Outcome Measures

Primary Outcomes (18)

• Endogenous thrombin potential (ETP)

  nmol/l x min

  0 months, 3 months

• Endogenous trombin lag time (LT)

  min

  0 months, 3 months

• Endogenous trombin peak height

  nmol/l

  0 months, 3 months

• Factor VIII (FVIII)

  Percentage

  0 months, 3 months

• Antithrombin

  Percentage

  0 months, 3 months

• Protein S

  Percentage

  0 months, 3 months

• Protein C

  Percentage

  0 months, 3 months

• D-dimer

  ng/mL

  0 months, 3 months

• CRP

  mg/l

  0 months, 3 months

• Fibrinogen

  g/l

  0 months, 3 months

• Tissue-type plaminogen activator (t-PA)

  ng/mL

  0 months, 3 months

• Plasminogen activator inhibitor type 1 (PAI-1)

  ng/mL

  0 months, 3 months

• Faktor XII (FXII)

  μg/mL

  0 months, 3 months

• Prekallikrein (PK)

  μg/mL

  0 months, 3 months

• H-Kininogen (HK)

  Percentage

  0 months, 3 months

• Cleaved H-Kininogen (cHK)

  μg/mL

  0 months, 3 months

• C1-esterase inhibitor (C1-inh)

  g/L

  0 months, 3 months

• Endogenous kallikrein potential (EKP)

  nmol/L x min

  0 months, 3 months

Study Arms (1)

Vaginal estrogen treatment

OTHER

Drug: Vaginal estradiol tablets

Interventions

Vaginal estradiol tablets DRUG

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

Vaginal estrogen treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark

Aarhus N, 8200, Denmark

RECRUITING

Central Study Contacts

Pinar Bor, Pinar Bor, MD, PhD, Prof.

CONTACT

+45 78 42 11 13; isipinbo@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 8, 2025
• Study Start: March 21, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-05

Locations

DK (1)