Vagina AtrophyPhase 4NCT07160504
Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women
A Phase 4 study testing Vaginal estradiol tablets in people with Vagina Atrophy, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Vagina Atrophy
- What is being tested?
- Vaginal estradiol tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Mar 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark
Aarhus N, 8200
Pinar Bor, MD, PhD, Prof., 22504767, isipinbo@rm.dk
About this study
Official title: Is There an Effect of Local Vaginal Estrogen Treatment on the Hemostatic Parameters in Postmenopausal Women?
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.
Read the 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.
- Conditions
- Vagina Atrophy
- Being tested
- Vaginal estradiol tablets
- Keywords
- Postmenopausal, Hemostasis, Venous thromboembolic event
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal estradiol tabletsDrug
Vaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic).
| Study group | Role | What they receive |
|---|---|---|
| Vaginal estrogen treatment | Other | Not described Receives: Drug: Vaginal estradiol tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous thrombin potential (ETP)
nmol/l x min
Measured: 0 months, 3 months
Endogenous trombin lag time (LT)
min
Measured: 0 months, 3 months
Endogenous trombin peak height
nmol/l
Measured: 0 months, 3 months
Factor VIII (FVIII)
Percentage
Measured: 0 months, 3 months
Antithrombin
Percentage
Measured: 0 months, 3 months
Protein S
Percentage
Measured: 0 months, 3 months
Protein C
Percentage
Measured: 0 months, 3 months
D-dimer
ng/mL
Measured: 0 months, 3 months
CRP
mg/l
Measured: 0 months, 3 months
Fibrinogen
g/l
Measured: 0 months, 3 months
Tissue-type plaminogen activator (t-PA)
ng/mL
Measured: 0 months, 3 months
Plasminogen activator inhibitor type 1 (PAI-1)
ng/mL
Measured: 0 months, 3 months
Faktor XII (FXII)
μg/mL
Measured: 0 months, 3 months
Prekallikrein (PK)
μg/mL
Measured: 0 months, 3 months
H-Kininogen (HK)
Percentage
Measured: 0 months, 3 months
Cleaved H-Kininogen (cHK)
μg/mL
Measured: 0 months, 3 months
C1-esterase inhibitor (C1-inh)
g/L
Measured: 0 months, 3 months
Endogenous kallikrein potential (EKP)
nmol/L x min
Measured: 0 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start21 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vagina AtrophyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160504
- Sponsor's protocol ID
- 2024-519539-41-00
- Other IDs
- 2024-519539-41-00
- Status last verified
- May 2025
- First submitted
- 13 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Effect of Local Vaginal Estrogen Treatment on the Hemostatic Parameters in Postmenopausal Women?
- ClinicalTrials.gov ID
- NCT07160504
- Acronym / sponsor ID
- 2024-519539-41-00
- Conditions
- Vagina Atrophy
- Keywords
- Postmenopausal, Hemostasis, Venous thromboembolic event
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal estrogen treatment | Other | Drug: Vaginal estradiol tablets |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal estradiol tabletsVaginal estrogen tablets 10 µg at least 3 times a week (on indication, prescribed at the outpatient clinic). | Drug | Vaginal estrogen treatment |
Primary outcome
Endogenous thrombin potential (ETP)
Time frame: 0 months, 3 months
nmol/l x min
Endogenous trombin lag time (LT)
Time frame: 0 months, 3 months
min
Endogenous trombin peak height
Time frame: 0 months, 3 months
nmol/l
Factor VIII (FVIII)
Time frame: 0 months, 3 months
Percentage
Antithrombin
Time frame: 0 months, 3 months
Percentage
Protein S
Time frame: 0 months, 3 months
Percentage
Protein C
Time frame: 0 months, 3 months
Percentage
D-dimer
Time frame: 0 months, 3 months
ng/mL
CRP
Time frame: 0 months, 3 months
mg/l
Fibrinogen
Time frame: 0 months, 3 months
g/l
Tissue-type plaminogen activator (t-PA)
Time frame: 0 months, 3 months
ng/mL
Plasminogen activator inhibitor type 1 (PAI-1)
Time frame: 0 months, 3 months
ng/mL
Faktor XII (FXII)
Time frame: 0 months, 3 months
μg/mL
Prekallikrein (PK)
Time frame: 0 months, 3 months
μg/mL
H-Kininogen (HK)
Time frame: 0 months, 3 months
Percentage
Cleaved H-Kininogen (cHK)
Time frame: 0 months, 3 months
μg/mL
C1-esterase inhibitor (C1-inh)
Time frame: 0 months, 3 months
g/L
Endogenous kallikrein potential (EKP)
Time frame: 0 months, 3 months
nmol/L x min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaginal estradiol tablets in people with Vagina Atrophy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pinar Bor, Pinar Bor, MD, PhD, Prof. (+45 78 42 11 13, isipinbo@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous thrombin potential (ETP) (time frame: 0 months, 3 months). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.