Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT07160504
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Is There an Effect of Local Vaginal Estrogen Treatment on the Hemostatic Parameters in Postmenopausal Women?
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-519539-41-00 | CTIS | None | View |