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Clinical Trials in Denmark / NCT07160504
Recruiting Phase 4

Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women

NCT07160504 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Phase 4
Started
2025-03-21
Last updated
2025-09-08

Condition(s) studied

Vagina Atrophy

Investigational drug(s) / intervention(s)

Vaginal estradiol tablets

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

Study 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.

Eligibility

Sex
FEMALE
Min age
50 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark Aarhus N Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07160504 on ClinicalTrials.gov ↗ ← All trials in Denmark