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Vaginal estrogen safety under scrutiny: new study targets blood clot risk

NCT ID NCT07160504

Knowledge-focused Sponsor: University of Aarhus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether vaginal estrogen tablets, used to treat vaginal atrophy, change blood clotting factors in postmenopausal women. Researchers will take blood samples before and after 3 months of treatment. The goal is to see if this common treatment might raise or lower the risk of blood clots, especially in women who have had a clot before.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vaginal estradiol tablets
What this could lead to
If it works, this could clarify whether local vaginal estrogen is safe for women with a history of blood clots.
What could go wrong
This is a small, early-phase study focused on lab markers, not clinical outcomes. Results may not change current practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

postmenopausal atrophic vaginitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vagina atrophy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark

    RECRUITING

    Aarhus N, 8200, Denmark