Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaginal estradiol tablets.
- Who it may be relevant to
- Registry conditions: Vagina Atrophy. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Is There an Effect of Local Vaginal Estrogen Treatment on the Hemostatic Parameters in Postmenopausal Women?
Overview
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.
Interventions
- Drug Vaginal estradiol tablets
Vaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic).
Primary outcome measures
- Endogenous thrombin potential (ETP) [Time frame: 0 months, 3 months]
- Endogenous trombin lag time (LT) [Time frame: 0 months, 3 months]
- Endogenous trombin peak height [Time frame: 0 months, 3 months]
- Factor VIII (FVIII) [Time frame: 0 months, 3 months]
- Antithrombin [Time frame: 0 months, 3 months]
- Protein S [Time frame: 0 months, 3 months]
- Protein C [Time frame: 0 months, 3 months]
- D-dimer [Time frame: 0 months, 3 months]
- CRP [Time frame: 0 months, 3 months]
- Fibrinogen [Time frame: 0 months, 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark — Aarhus N
Identifiers
NCT: NCT07160504 · 2024-519539-41-00 · 2024-519539-41-00